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OpenTrials
Completed

NCT Number: NCT00629928

Ulcer Prevention II

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

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Key information

Conditions

NSAID Associated Gastric Ulcers Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No active/current gastric or duodenal ulcer on baseline endoscopy.
  • A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
  • Other inclusion criteria, as defined in the protocol.

Exclusion criteria

  • 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.

Treatment and study plan

Esomeprazole

Drug

20mg oral capsule daily

Other names: Nexium

Placebo

Drug

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 treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy.

    Time frame: Assessments at Week 0, Week 4, Week 12, Week 26

Secondary outcomes

  1. 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 20 mg qd versus placebo in patients receiving daily NSAID therapy.

    Time frame: Assessments at Week 0, Week 4, Week 12, Week 26

  2. Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy.

    Time frame: Assessments at Week 0, Week 4, Week 12, Week 26

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Mar 6, 2008
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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