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Completed

NCT Number: NCT00595517

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

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Key information

Conditions

Gastric Ulcer Arthritis Arthritis, Rheumatoid Autoimmune Diseases Back Pain Connective Tissue Diseases Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Immune System Diseases Intestinal Diseases Joint Diseases Low Back Pain Lumbago Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Peptic Ulcer Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases Stomach Diseases Stomach Ulcer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Saitama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Medical history of gastric and/or duodenal ulcer
  • A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion criteria

  • Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
  • History of esophageal, gastric or duodenal surgery
  • Having severe liver disease or chronic renal disease

Treatment and study plan

Esomeprazole 20 mg

Drug

Esomeprazole 20 mg once daily

Primary outcomes

  1. Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period

    Time frame: up to 52 weeks

Secondary outcomes

  1. Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment

    Time frame: up to 4 weeks after treatment

  2. Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment

    Time frame: up to 12 weeks after treatment

  3. Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment

    Time frame: up to 24 weeks after treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2008
Registry last updated
Sep 14, 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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