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

Tracking Information
First Submitted Date ICMJE	October 18, 2005
First Posted Date ICMJE	October 19, 2005
Last Update Posted Date	January 24, 2011
Study Start Date ICMJE	January 2001
Actual Primary Completion Date	August 2002 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 18, 2005)	To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00241540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 18, 2005)	- To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy; - To assess the impact of treatment
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Official Title ICMJE	Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo & 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
Brief Summary	This study is 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 period of 4 weeks in treatment of relief of upper GI symptoms.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	GERD
Intervention ICMJE	Drug: Esomeprazole
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: October 18, 2005)	808
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2002
Actual Primary Completion Date	August 2002 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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). 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, France, Germany, Hungary, Spain, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00241540
Other Study ID Numbers ICMJE	D9617C00001; SH-NEN-0001
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	AstraZeneca
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
PRS Account	AstraZeneca
Verification Date	January 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP