- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00633412
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only
June 9, 2009 updated by: AstraZeneca
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers.
This study looks at the treatment of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
- A gastric ulcer >= 5mm in diameter, but no ulcer >25 mm at its greatest diameter, at the baseline endoscopy.
- Other key inclusion criteria, as specified in the protocol.
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.
- Many other conditions and criteria, as specified in the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
20mg Oral tablet daily
|
20mg oral daily
Other Names:
40mg oral tablet daily
Other Names:
|
EXPERIMENTAL: 2
40mg Oral tablet daily
|
20mg oral daily
Other Names:
40mg oral tablet daily
Other Names:
|
ACTIVE_COMPARATOR: 3
150mg oral twice daily
|
150mg oral twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of patients with no gastric ulcers after 8 weeks of treatment.
Time Frame: Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.
|
Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N
Time Frame: Assessments at Week 0, Week 4 and Week 8
|
Assessments at Week 0, Week 4 and Week 8
|
To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.
Time Frame: Assessments at Week 0, Week 4 and Week 8
|
Assessments at Week 0, Week 4 and Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Study Completion (ACTUAL)
March 1, 2003
Study Registration Dates
First Submitted
March 5, 2008
First Submitted That Met QC Criteria
March 11, 2008
First Posted (ESTIMATE)
March 12, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 11, 2009
Last Update Submitted That Met QC Criteria
June 9, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Peptic Ulcer
- Duodenal Diseases
- Ulcer
- Stomach Ulcer
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Histamine Antagonists
- Histamine Agents
- Histamine H2 Antagonists
- Ranitidine
- Ranitidine bismuth citrate
- Esomeprazole
Other Study ID Numbers
- SH-NEN-0005
- D9617C00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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