Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-Induced Gastric Ulcer
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Ulcer
Intervention: Esomeprazole (Drug); Ranitidine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Tore Lind, MD, Study Director, Affiliation: AstraZeneca
Overall contact:
AstraZeneca China Study Information, Phone: +86 21 52564555
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 NSAID therapy.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg qd Versus Ranitidine 150 mg Bid in Patients With an NSAID-Associated Gastric Ulcer When Daily NSAID is Continued
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Assess the efficacy of esomeprazole 20 mg qd through 4 weeks of treatment in these patients
Secondary outcome: Assess the efficacy of esomeprazole 20 mg qd through 8 weeks of treatment in these patients.Evaluate the patient symptoms for up to 8 weeks of treatment in these patients. Evaluate the safety and tolerability for up to 8 weeks of treatment in these patients.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
AstraZeneca China Study Information, Phone: +86 21 52564555
Research Site, Shanghai, China; Recruiting
Research Site, Beijing, China; Recruiting
Research Site, Hong Kong, Hong Kong; Not yet recruiting
Research Site, Fuzhou, Fujian, China; Recruiting
Research Site, Guangzhou, Guangdong, China; Recruiting
Research Site, Ha'er bin, Heilongjiang, China; Recruiting
Research Site, Wuhan, Hubei, China; Recruiting
Research Site, Suzhou, Jiangsu, China; Recruiting
Research Site, Shenyang, Liaoning, China; Recruiting
Research Site, Xi'an, Shanxi, China; Recruiting
Additional Information
Starting date: March 2006
Last updated: August 15, 2007
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