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

January 24, 2011 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: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

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

Description

Inclusion Criteria:

  1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
  2. Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

  1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
  2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
  3. 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
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
20mg Oral tablet daily
Drug: Esomeprazole
20mg Oral tablet once daily
Other Names:
  • Nexium
Drug: Esomeprazole
40mg oral tablet once daily
Other Names:
  • Nexium
ACTIVE_COMPARATOR: 3
150mg oral twice daily
Drug: Ranitidine
150mg oral twice daily
Other Names:
  • Zantac
EXPERIMENTAL: 2
40mg oral tablet daily
Drug: Esomeprazole
20mg Oral tablet once daily
Other Names:
  • Nexium
Drug: Esomeprazole
40mg oral tablet once daily
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
Time Frame: Assessments at week 0, week 4 and week 8
Assessments at week 0, week 4 and week 8
Safety and tolerability of the treatments for 8 weeks of treatment.
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

AstraZeneca

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

Primary Completion (ACTUAL)

October 1, 2003

Study Completion (ACTUAL)

October 1, 2003

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (ESTIMATE)

March 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-NEN-0006

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.

Clinical Trials on NSAID Associated Gastric Ulcers

Clinical Trials on Ranitidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe