Prevention of Gastric Ulcers

NSAID Associated Gastric Ulcers Clinical Trial

Official title:

A Comparative Efficacy and Safety Study of Nexium (Esomeprazole Magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric Ulcers Associated With Daily NSAID Use in Patients at Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629512
• Other study ID #: SH-NEN-0013
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2008
• Last updated: March 12, 2009
• Start date: March 2001
• Est. completion date: December 2002

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBulgaria: Ministry of HealthBrazil: National Health Surveillance AgencyCanada: Health CanadaHong Kong: Department of HealthHungary: National Institute of PharmacyMexico: Ministry of HealthNorway: Directorate of HealthPoland: Ministry of Science and Higher EducationSweden: Medical Products AgencySingapore: Clinical Trials & Epidemiology Research Unit (CTERU)United States of America: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention 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; versus placebo; in patients at risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. No gastric or duodenal ulcer on baseline endoscopy.

2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.

3. Other inclusion criteria, as defined in the protocol.

Exclusion Criteria:

1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.

2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.

3. Other criteria, as defined in the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• NSAID Associated Gastric Ulcers
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Esomeprazole
20mg oral daily
• Esomeprazole
40mg oral daily
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk		Assessments at Week 0, Week 4, Week 12, Week 26
Secondary	Investigator-assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo in patients receiving daily NSAID therapy.		Assessments at Week 0, Week 4, Week 12, Week 26
Secondary	Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy		Assessments at Week 0, Week 4, Week 12, Week 26