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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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

Research Site

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

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.

Age, Customized

Gender, Male/Female

Region of Enrollment

8 participants had a missing for this measurement (3 participants in Esomeprazole 20 mg group and 5 participants in Placebo group). Negative means a patient had no Helicobacter pylori infection and Positive means a patient had Helicobacter pylori infection.

Helicobacter pylori status

Study Specific Characteristic

0 - 12 weeks

13 - 24 weeks

25 - 36 weeks

37 - 48 weeks

Participants not taking investigational drug were not included. In total 364 participants were included in the efficacy evaluation at the interim analysis. 24 of the 364 total participants had an occurrence of gastric and/or duodenal ulcers by the 48-week assessment.

Time from randomization to occurrence of gastric and/or duodenal ulcers up to data cut-off date for interim analysis.

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.

Participants who had LANZA scores at both baseline and post-dose were included into this analysis.

Change in degree of gastric mucosal lesion by modified Lanza scale from baseline to last measurement up to Week 48

12 weeks

24 weeks

36 weeks

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.

Patients with endoscopy were included in the analyses at 12, 24, 36 and 48 weeks after randomisation.

Number of participants with Reflux esophagitis evaluated by the LA classification up to Week 48.

Improved

Unchanged

Worsened

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".

Participants who had the measurements of epigastric pain at baseline and post-dose up to 48 weeks were included in this analysis.

Change in the severity of Epigastric pain from baseline to last measurement  up to Week 48

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".

Participants who had the measurements of heartburn at baseline and post-dose up to 48 weeks were included in this analysis.

Change in the severity of Heartburn from baseline to last measurement  up to Week 48.

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".

Participants who had the measurements of anorexia at baseline and post-dose up to 48 weeks were included in this analysis.

Change in the severity of Anorexia from baseline to last measurement  up to Week 48

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".

Participants who had the measurements of abdomen enlarged feeling at baseline and post-dose up to 48 weeks were included in this analysis.

Change in the severity of Abdomen enlarged feeling from baseline to last measurement  up to Week

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".

Participants who had the measurements of Nausea and/or Vomiting at baseline and post-dose up to 48 weeks were included in this analysis.

Change in the severity of Nausea and/or Vomiting from baseline to last measurement  up to Week 48

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".

Change in the severity of Discomfort in the stomach from baseline to last measurement  up to Week 48

Adverse event

Adverse event (Frequency>=5%)

Death

Serious adverse event other than death

Adverse event leading to discontinuation of study

Drug-related adverse event

Severe adverse event

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

All participants who received any study drug were included in this analysis.

Number of participants with adverse events

Randomised and included in the analyses

At data cut off date (26 Feb 2011)

Out of 914 enrolled participants, 430 participants were assigned , but 484 participants were not assigned. The major reasons of no assignment were 'Did not meet eligibility criteria' (462 participants) and 'Voluntary discontinuation by participant' (21 participants). After 366 participants were randomised, the interim analysis was done.

Arms	Assigned Interventions
Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily oral	Drug: Esomeprazole 20mg, capsule, 72 weeks
Placebo Comparator: Placebo Placebo once daily oral	Drug: Placebo Placebo, capsule, 72 weeks

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR-D961PC00001.pdf

D961PC00001- Clinical Study Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator