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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00241527
Registration number
NCT00241527
Ethics application status
Date submitted
18/10/2005
Date registered
19/10/2005
Date last updated
24/01/2011
Titles & IDs
Public title
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Query!
Scientific 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
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Secondary ID [1]
0
0
SH-NEN-0003
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Secondary ID [2]
0
0
D9617C00003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSAIDs
0
0
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Upper GI Symptoms
0
0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Mean change in the upper GI symptoms (pain, discomfort or
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Assessment method [1]
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Timepoint [1]
0
0
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Primary outcome [2]
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0
burning in the upper abdomen), rated on a 7-graded severity scale
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Assessment method [2]
0
0
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Timepoint [2]
0
0
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Secondary outcome [1]
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- Mean change in the upper GI symptom score
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Assessment method [1]
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0
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Timepoint [1]
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Secondary outcome [2]
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- The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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- Mean upper GI symptom score by day over the duration of the study.
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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- Proportions of patients with upper GI symptoms during night, over the duration of the study.
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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- 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.
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [9]
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- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
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Assessment method [9]
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Timepoint [9]
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Secondary outcome [10]
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-Short Form-36 (SF-36) score at baseline.
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Assessment method [10]
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Timepoint [10]
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2002
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Research Site - Five Dock
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Research Site - Carina Heights
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Research Site - Kippa Ring
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Research Site - Ivanhoe
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- Five Dock
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- Carina Heights
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- Kippa Ring
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- Ivanhoe
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Funding & Sponsors
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Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00241527
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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AstraZeneca Nexium Medical Sciences Director, MD
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00241527
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