Prevention of Gastric Ulcers

NCT00629512 | Completed Phase 3

• 1 other identifier: SH-NEN-0013
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

NSAID Associated Gastric Ulcers

Keywords

NSAID, Nexium, esomeprazole, Gastric Ulcers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (3)

1

EXPERIMENTAL

20mg oral daily

Drug: Esomeprazole

2

EXPERIMENTAL

40mg oral daily

Drug: Esomeprazole

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Esomeprazole DRUG

20mg oral daily

Also known as: Nexium

1

Placebo DRUG

3

Eligibility Criteria

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

You may qualify if:

• No gastric or duodenal ulcer on baseline endoscopy.
• A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.

You may not qualify if:

• History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
• History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
• Other criteria, as defined in the protocol.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Esomeprazole

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

Study Officials

• Professor Chris Hawkey

  Queens Medical Centre

  PRINCIPAL INVESTIGATOR

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 6, 2008
• Study Start: March 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: March 13, 2009

Record last verified: 2009-03