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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

Primary Purpose

NSAID Associated Gastric Ulcers

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Esomeprazole

Ranitidine

Esomeprazole

About this trial

This is an interventional treatment trial for NSAID Associated Gastric Ulcers focused on measuring NSAID, Nexium, esomeprazole, Gastric Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

20mg Oral tablet daily

40mg Oral tablet daily

150mg oral twice daily

Outcomes

Primary Outcome Measures

The proportion of patients with no gastric ulcers after 8 weeks of treatment.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT00633412

First Posted

March 5, 2008

Last Updated

June 9, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00633412

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

February 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSAID Associated Gastric Ulcers

Keywords

NSAID, Nexium, esomeprazole, Gastric Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

20mg Oral tablet daily

Arm Title

Arm Type

Experimental

Arm Description

40mg Oral tablet daily

Arm Title

Arm Type

Active Comparator

Arm Description

150mg oral twice daily

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

20mg oral daily

Intervention Type

Drug

Intervention Name(s)

Ranitidine

Other Intervention Name(s)

Zantac

Intervention Description

150mg oral twice daily

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

40mg oral tablet daily

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Time Frame

Assessments at Week 0, Week 4 and Week 8

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paula Fernstrom

Organizational Affiliation

Nexium Global Product Director, AstraZeneca

Official's Role

Study Director

12. IPD Sharing Statement

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