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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
SH-NEN-0003
Secondary ID [2] 0 0
D9617C00003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSAIDs 0 0
Upper GI Symptoms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Esomeprazole

Treatment: Drugs: Esomeprazole
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in the upper GI symptoms (pain, discomfort or
Timepoint [1] 0 0
Primary outcome [2] 0 0
burning in the upper abdomen), rated on a 7-graded severity scale
Timepoint [2] 0 0
Secondary outcome [1] 0 0
- Mean change in the upper GI symptom score
Timepoint [1] 0 0
Secondary outcome [2] 0 0
- The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
- Mean upper GI symptom score by day over the duration of the study.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
- Proportions of patients with upper GI symptoms during night, over the duration of the study.
Timepoint [5] 0 0
Secondary outcome [6] 0 0
- 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.
Timepoint [6] 0 0
Secondary outcome [7] 0 0
- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [7] 0 0
Secondary outcome [8] 0 0
- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
Timepoint [8] 0 0
Secondary outcome [9] 0 0
- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
Timepoint [9] 0 0
Secondary outcome [10] 0 0
-Short Form-36 (SF-36) score at baseline.
Timepoint [10] 0 0

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2002
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Five Dock
Recruitment hospital [2] 0 0
Research Site - Carina Heights
Recruitment hospital [3] 0 0
Research Site - Kippa Ring
Recruitment hospital [4] 0 0
Research Site - Ivanhoe
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- Five Dock
Recruitment postcode(s) [2] 0 0
- Carina Heights
Recruitment postcode(s) [3] 0 0
- Kippa Ring
Recruitment postcode(s) [4] 0 0
- Ivanhoe
Recruitment outside Australia
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United States of America
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Alabama
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Yoxall

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00241527
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Nexium Medical Sciences Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries