drugset / Trial / NCT01822665

Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

NCT01822665 ↗

Phase 4 Completed 28 enrolled GlaxoSmithKline
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2012-02
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 500 mg Oral
Comparator Ibuprofen Small molecule 400 mg Oral