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

NCT00633412 | Completed Phase 3

• 2 other identifiers: SH-NEN-0005D9617C00005
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSAID Associated Gastric Ulcers

Keywords

NSAID; Nexium; esomeprazole; Gastric Ulcers

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• 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

  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.

  Assessments at Week 0, Week 4 and Week 8

Study Arms (3)

1

EXPERIMENTAL

20mg Oral tablet daily

Drug: Esomeprazole

2

EXPERIMENTAL

40mg Oral tablet daily

Drug: Esomeprazole

3

ACTIVE COMPARATOR

150mg oral twice daily

Drug: Ranitidine

Interventions

Esomeprazole DRUG

20mg oral daily

Also known as: Nexium

1

Ranitidine DRUG

150mg oral twice daily

Also known as: Zantac

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Esomeprazole; Ranitidine

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 12, 2008
• Study Start: February 1, 2001
• Study Completion: March 1, 2003
• Last Updated: June 11, 2009

Record last verified: 2009-06