Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

Completed · Phase 4 · Has a placebo group

Conditions studied: Gastrointestinal Mucosal Damage

In brief

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.

Key facts

Study ID

NCT01822665

Run by

GlaxoSmithKline

People needed

28

Starts

2012-02-01

Expected to finish

2012-07-01

Last updated by the study team

2014-03-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index: 18-30 kg/m\^2
• Body Weight 60-80 kg
• Participant with both a normal stomach and proximal duodenum mucosa as evidenced by endoscopic results

You may not qualify if…

• Participant with evidence of current/active, or a history of gastrointestinal disease
• Participant with a history of renal disease, pulmonary edema, cardiomyopathy, liver disease, intrinsic coagulation defects, bleeding diseases or anticoagulant therapy
• Participant with a history of using antacids, H2 receptor antagonists, proton pump inhibitors, or misoprostol more than twice a month or has used any of these medications within 1 week of Visit 1.
• Participant with a current or recurrent disease, within 12 months of Visit 1, that could affect the action, absorption, disposition, or excretion of the study treatments or evaluation of the clinical or laboratory tests

Where it is running

• Houston Institute for Clinical Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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