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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00241553




Registration number
NCT00241553
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 Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Scientific title
Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs
Secondary ID [1] 0 0
SH-NEN-0004
Secondary ID [2] 0 0
D9617C00004
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the efficacy of esomeprazole versus placebo through 6 months of treatment for the prevention of relapse of upper GI symptom associated with NSAID use
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Signed informed consent.
* Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
* A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs.
* Daily NSAID treatment dose and type:
* Must have been stable for at least 9 weeks prior to inclusion
* Are expected to remain stable for the duration of the study.
* Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally.
* Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Discontinuation from study SH-NEN-0003
* 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.
* Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.

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
1/04/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2003
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Research Site - Five Dock
Recruitment hospital [2] 0 0
Research Site - Various Cities
Recruitment hospital [3] 0 0
Research Site - Carina Heights
Recruitment hospital [4] 0 0
Research Site - Kippa Ring
Recruitment hospital [5] 0 0
Research Site - Ivanhoe
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- Five Dock
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- Various Cities
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- Carina Heights
Recruitment postcode(s) [4] 0 0
- Kippa Ring
Recruitment postcode(s) [5] 0 0
- Ivanhoe
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess theefficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.
Trial website
https://clinicaltrials.gov/study/NCT00241553
Trial related presentations / publications
Hawkey CJ, Talley NJ, Scheiman JM, Jones RH, Langstrom G, Naesdal J, Yeomans ND; NASA/SPACE author group. Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies. Arthritis Res Ther. 2007;9(1):R17. doi: 10.1186/ar2124.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00241553