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Report for Clinical Trial NCT01069939

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01069939 Prevention
MeSH: Duodenal Ulcer
HPO: Duodenal ulcer

2 Interventions

Name: Esomeprazole

Description: 20mg, capsule, 72 weeks

Type: Drug

Esomeprazole 20mg

Name: Placebo

Description: Placebo, capsule, 72 weeks

Type: Drug

Placebo


Primary Outcomes

Description: 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.

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

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

Secondary Outcomes

Description: 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.

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

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

Description: 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.

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

Time: 12, 24, 36 and 48 weeks

Description: 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".

Measure: Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48

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

Description: 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".

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

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

Description: 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".

Measure: Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48

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

Description: 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".

Measure: Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week

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

Description: 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".

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

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

Description: 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".

Measure: Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48

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

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

Measure: Number of Participants With Adverse Events

Time: Up to 70 weeks at the longest

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 D961H

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. --- D961H ---

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. --- D961H ---

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. --- D961H --- --- D961H ---



HPO Nodes


HPO:
Duodenal ulcer
Genes 5
PLG ARID1B PLA2G4A PLG PLG