At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 28 enrolled
Drug / intervention
Ibuprofen +2 moredrug
Likely dose
Ibuprofen 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination
In Brief
A Phase 4 clinical trial evaluating Ibuprofen, Paracetamol, and 1 other intervention for Gastrointestinal Mucosal Damage. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study evaluated the effect of oral fast-dissolving formulations of paracetamol and ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic examinations were conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Mucosal Damage
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
Primary CompletionJul 2012
First PostedApr 2013
TodayJul 2026
First PostedApr 2, 2013
Enrollment StartFeb 1, 2012
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.3 years ago
Interventions
Ibuprofendrug
Liquid gelation capsules or tablets of 400 mg strength
Paracetamoldrug
Paracetamol fast dissolving tablets of 500 mg strength
Placeboother
Placebo tablets