Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241527
First received: October 18, 2005
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.


Condition Intervention Phase
NSAIDs
Upper GI Symptoms
Drug: Esomeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo and Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Mean change in the upper GI symptoms (pain, discomfort or
  • burning in the upper abdomen), rated on a 7-graded severity scale

Secondary Outcome Measures:
  • - Mean change in the upper GI symptom score
  • - The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
  • - Mean upper GI symptom score by day over the duration of the study.
  • - Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
  • - Proportions of patients with upper GI symptoms during night, over the duration of the study.
  • - The proportion of patients with resolution or relief of investigator-recorded symptoms of heartburn, acid regurgitation, nausea & upper abdominal bloating at the 2-week, and 4-week visits.
  • - The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
  • - Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
  • - Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
  • -Short Form-36 (SF-36) score at baseline.

Estimated Enrollment: 556
Study Start Date: December 2000
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • 18 years of age, or older.
  • Capable of completing the diary card.
  • Ability to complete the HRQL questionnaires.
  • A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).
  • Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)
  • Hp negative by UBT, serology or biopsy based test, at visit 1.

Exclusion Criteria:

  • Current, or history of, gastric or duodenal ulcer
  • Current, or history of, esophageal, gastric or duodenal surgery.
  • History of GERD, not associated with NSAID use.
  • Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
  • Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
  • Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241527

  Show 131 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00241527     History of Changes
Other Study ID Numbers: D9617C00003, SH-NEN-0003
Study First Received: October 18, 2005
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014