EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

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.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Study of esomeprazole 20 mg or 40 mg vs placebo effectiveness on the occurrence of peptic ulcers in subjects on Low Dose Acetylsalicylic Acid (LDA)

AstraZeneca Clinical Trial Information – Outside US

Research Site

A randomized, double-blind, parallel-group, multicentre, phase III study to
            assess the effect of esomeprazole 20 or 40 mg od versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low dose acetylsalicylic acid (ASA)

The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Age Categorical

Gender, Male/Female

Not enough patients had peptic ulcer, gastric ulcer, or duodenal ulcer to report the intended primary endpoint of time to peptic ulcer and two secondary endpoints, time to gastric ulcer and time to duodenal ulcer.  Percentage used instead.

Percentage of participants who experienced the occurence of peptic ulcer(s).

The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Percentage of participants who experienced the occurence of gastric ulcer.

The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Percentage of participants who experienced the occurrence of duodenal ulcer.

RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.

Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.

Number of participants reporting 0 in the dichotomized RDQ (Reflux and Disease Questionnaire) score (0 versus >0) for the dyspepsia dimension during the 26-week visit or the week prior to the last visit.

RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'.  Best score possible 0, worst score possible - daily occurrence.

Number of participants reporting 0 in the dichotomized RDQ (Reflux and Disease Questionnaire) score (0 versus >0) for the Gastroesophageal reflux disease dimension during the 26-week visit or the week prior to the last visit.

Patients randomized who had endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Arms	Assigned Interventions
Experimental: Esomeprazole 40 mg Esomeprazole 40 mg	Drug: Esomeprazole 40 mg Esomeprazole 40 mg once daily
Experimental: Esomeprazole 20 mg Esomeprazole 20 mg	Drug: Esomeprazole 20 mg Esomeprazole 20 mg once daily
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo once daily

Study of esomeprazole 20 mg or 40 mg vs placebo effectiveness on the occurrence of peptic ulcers in subjects on Low Dose Acetylsalicylic Acid (LDA) - Oberon

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

AstraZeneca Clinical Trial Information – Outside US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=443&filename=CSP-D961FC00003.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=443&filename=CSR-D961FC00003.pdf

CSP-D961FC00003.pdf

CSR-D961FC00003.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator