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Completed

NCT Number: NCT00787254

Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).

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Key information

Conditions

Stomach Ulcer Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasugai-shi, Aichi-ken, Japan

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About this study

In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
  • The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion criteria

  • Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
  • Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
  • Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.
  • Past or planned surgery affecting gastric acid secretion.
  • Clinically significant hepatic or renal disorder.
  • Serious cardiac dysfunction, hypertension, or hematological disorder.

Treatment and study plan

Lansoprazole

Drug

Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.

Other names: AG-1749

Gefarnate

Drug

Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.

Primary outcomes

  1. Number of Participants With Gastric Ulcer and/or Duodenal Ulcer

    Time frame: 24 Months

    The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.

Secondary outcomes

  1. Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

    Time frame: Baseline and Month 3.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  2. Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

    Time frame: Baseline and Month 6.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  3. Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

    Time frame: Baseline and Month 12.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  4. Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

    Time frame: Baseline and Month 18.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  5. Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

    Time frame: Baseline and Month 24.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  6. Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

    Time frame: Baseline and Month 3.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  7. Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

    Time frame: Baseline and Month 6.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  8. Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

    Time frame: Baseline and Month 12.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  9. Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

    Time frame: Baseline and Month 18.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  10. Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

    Time frame: Baseline and Month 24.

    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  11. Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)

    Time frame: On occurrence (up to month 24).

    Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.

  12. Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)

    Time frame: Baseline and Month 3.

    The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  13. Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)

    Time frame: Baseline and Month 6.

    The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  14. Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)

    Time frame: Baseline and Month 12.

    The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  15. Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)

    Time frame: Baseline and Month 18.

    The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  16. Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)

    Time frame: Baseline and Month 24.

    The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  17. Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)

    Time frame: Baseline and Month 3.

    The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  18. Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)

    Time frame: Baseline and Month 6.

    The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  19. Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)

    Time frame: Baseline and Month 12.

    The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  20. Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)

    Time frame: Baseline and Month 18.

    The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  21. Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)

    Time frame: Baseline and Month 24.

    The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  22. Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)

    Time frame: Baseline and Month 3.

    The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  23. Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)

    Time frame: Baseline and Month 6.

    The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  24. Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)

    Time frame: Baseline and Month 12.

    The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  25. Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)

    Time frame: Baseline and Month 18.

    The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  26. Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)

    Time frame: Baseline and Month 24.

    The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  27. Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)

    Time frame: Baseline and Month 3.

    The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  28. Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)

    Time frame: Baseline and Month 6.

    The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  29. Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)

    Time frame: Baseline and Month 12.

    The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  30. Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)

    Time frame: Baseline and Month 18.

    The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  31. Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)

    Time frame: Baseline and Month 24.

    The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  32. Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)

    Time frame: Baseline and Month 3.

    The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  33. Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)

    Time frame: Baseline and Month 6.

    The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  34. Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)

    Time frame: Baseline and Month 12.

    The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  35. Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)

    Time frame: Baseline and Month 18.

    The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  36. Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)

    Time frame: Baseline and Month 24.

    The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  37. Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)

    Time frame: Baseline and Month 3.

    The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  38. Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)

    Time frame: Baseline and Month 6.

    The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  39. Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)

    Time frame: Baseline and Month 12.

    The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  40. Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)

    Time frame: Baseline and Month 18.

    The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  41. Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)

    Time frame: Baseline and Month 24.

    The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  42. Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)

    Time frame: Baseline and Month 3.

    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  43. Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)

    Time frame: Baseline and Month 6.

    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  44. Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)

    Time frame: Baseline and Month 12.

    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  45. Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)

    Time frame: Baseline and Month 18.

    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  46. Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)

    Time frame: Baseline and Month 24.

    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  47. Number of Participants With Adverse Events

    Time frame: Per Incidence (up to 24 months).

    Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric and Duodenal Ulcers During Long-term Treatment With Nonsteroid Anti-inflammatory Drug

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 7, 2008
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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