NSAIDs, Upper GI Symptoms
Conditions
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.
Interventions
DRUGEsomeprazole
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy. | — |
Countries
Australia, Canada, Czechia, Italy, Norway, Poland, Slovakia, South Africa, Sweden, United Kingdom, United States
Outcome results
None listed