Status:
COMPLETED
Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Lead Sponsor:
GlaxoSmithKline
Conditions:
Gastrointestinal Mucosal Damage
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 cond...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01822665
Start Date
February 1 2012
End Date
July 1 2012
Last Update
March 31 2014
Active Locations (1)
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1
Houston Institute for Clinical Research
Houston, Texas, United States, 77074