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Completed

NCT Number: NCT00542789

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

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Key information

Conditions

Gastric Ulcer Arthritis Arthritis, Rheumatoid Autoimmune Diseases Back Pain Connective Tissue Diseases Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Immune System Diseases Intestinal Diseases Joint Diseases Low Back Pain Lumbago Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Peptic Ulcer Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases Stomach Diseases Stomach Ulcer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Chiryū, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Medical history of gastric and/or duodenal ulcer
  • A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion criteria

  • Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
  • History of esophageal, gastric or duodenal surgery
  • Having severe liver disease or chronic renal disease

Treatment and study plan

Esomeprazole

Drug

20mg once daily oral

Other names: Nexium

Placebo

Drug

once daily oral

Primary outcomes

  1. Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period

    Time frame: each visit up to 24 weeks

    The absence of gastric and/or duodenal ulcer throughout the treatment period

Secondary outcomes

  1. Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment

    Time frame: up to 4 weeks

    The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment

  2. Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment

    Time frame: up to 12 weeks

    The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Important dates

Study start
2007
Study completion
2009
First posted
Oct 12, 2007
Registry last updated
May 28, 2010

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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