Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00241527

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 III

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
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

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

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

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

Study ID Numbers:	D9617C00003, SH-NEN-0003
Study First Received:	October 18, 2005
Last Updated:	December 7, 2005
ClinicalTrials.gov Identifier:	NCT00241527 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Diseases
Omeprazole

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions
Digestive System Diseases

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009