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 assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug (NSAID)therapy.

Efficacy and safety study of Esomeprazole 20mg qd vs Ranitidine 150mg bid in patients with an NSAID-induced gastric ulcer

Research Site

A multicenter, randomized, double-blind, double-dummy, parallel-group, 8 week comparative efficacy and safety study of esomeprazole 20 mg every day (qd) versus Ranitidine 150 mg twice a day (bid) in patients with an NSAID-associated gastric ulcer when daily NSAID is continued

Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.
(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent).

Age Continuous

Gender, Male/Female

According to the protocol, the sample size was 320 patients which could achieve 80% power of superiority. Since the patient recruitment is very difficult, total 219 patients were randomized in present study, the power decreased to 60%

The percentage of subjects whose gastric ulcer(s) (GUs) was (were) healed at Week 4 after treatment with esomeprazole 20 mg qd and ranitidine 150 mg bid in patients receiving daily non-steroidal anti-inflammatory drug (NSAID)therapy.

Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.

The percentage of subjects whose gastric ulcer(s) was (were) healed at Week 8 after treatment with esomeprazole 20 mg qd and ranitidine 150 mg bid in patients receiving daily NSAID therapy.

Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at  Week 8.

The resolution of heartburn symptoms at week 4 and week 8 after treatment with esomeprazole 20 mg qd and ranitidine 150 mg bid in patients receiving daily NSAID therapy.

Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.

Percentage of participants with the occurance of any adverse event.  

Healed was defined as the absence of  ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.

The percentage of participants whose Duodenal ulcer(s) (DUs) was (were) healed at Week 4 and Week 8 after treatment with esomeprazole 20 mg qd and ranitidine 150 mg bid in patients receiving daily NSAID therapy.

Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.

The percentage of participants whose GU(s) and DU(s) in combination were healed at Week 4 and Week 8 after treatment with esomeprazole 20 mg qd and ranitidine 150 mg bid in patients receiving daily NSAID therapy

Overall Study

Total 397 patients from 24 centers in China were enrolled. 178 patients were not randomised due to unwillingness to continue the study or development of any exclusion criteria, etc. Total 219 patients were randomised, 217 patients were included in ITT population.

Efficacy and safety study of Esomeprazole 20mg qd vs Ranitidine 150mg bid in patients with an NSAID-induced gastric ulcer

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

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=441&filename=CSR-D9617L00001.pdf

CSR-D9617L00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator