Phase 3
N=219
Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
Gastric Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00401752 ↗Enrolled (actual)
219
Serious AEs
1.8%
Results posted
Jul 2010
Primary outcome: Primary: 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. — 59.4; 59.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole (Drug); Ranitidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
59.4; 59.5 | — |
| SECONDARY 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. |
81.1; 73.9 | — |
| SECONDARY 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. |
100; 97.7 | — |
| SECONDARY Percentage of Participants With the Occurance of Any Adverse Event. |
16.8; 22.7 | — |
| SECONDARY 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. |
93.3; 81.8 | — |
| SECONDARY 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 |
80.2; 69.4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent.
- A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months.
- Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally;
Exclusion Criteria
- History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
Data sourced from ClinicalTrials.gov (NCT00401752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.