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Completed

NCT Number: NCT01069939

Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Yotsukaidou, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of written informed consent before starting the study-related procedures and examinations
  • Patients who have the history of gastric and/or duodenal ulcer.
  • A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.

Exclusion criteria

  • Having gastric or duodenal ulcer (except for ulcer scar).
  • History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.

Treatment and study plan

Esomeprazole

Drug

20mg, capsule, 72 weeks

Placebo

Drug

Placebo, capsule, 72 weeks

Primary outcomes

  1. Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.

    Time frame: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)

    Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.

Secondary outcomes

  1. Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48

    Time frame: Up to 48 weeks (Baseline to last measurement)

    Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion.

  2. Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.

    Time frame: 12, 24, 36 and 48 weeks

    Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.

  3. Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48

    Time frame: Up to 48 weeks (Baseline to last measurement)

    The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

  4. Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.

    Time frame: Up to 48 weeks (Baseline to last measurement)

    The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

  5. Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48

    Time frame: Up to 48 weeks (Baseline to last measurement)

    The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

  6. Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week

    Time frame: Up to 48 weeks (Baseline to last measurement)

    The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

  7. Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48

    Time frame: Up to 48 weeks (Baseline to last measurement)

    The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

  8. Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48

    Time frame: Up to 48 weeks (Baseline to last measurement)

    The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

  9. Number of Participants With Adverse Events

    Time frame: Up to 70 weeks at the longest

    Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2010
Registry last updated
Nov 22, 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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