Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Mucosal Damage

Treatments: Drug: Paracetamol; Other: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01822665

A1901106

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 4 patient groups, including a placebo group

Paracetamol Tablet

Active Comparator group

Description:

Paracetamol 500 mg tablet, 2 tablets administered 4 times a day (QID) with water.

Treatment:

Drug: Paracetamol

Ibuprofen Tablet

Active Comparator group

Description:

Ibuprofen 400 mg tablet, 2 tablets administered three times a day (TID) with water

Treatment:

Drug: Ibuprofen

Placebo Tablet

Placebo Comparator group

Description:

Placebo tablets, 2 tablets QID administered with water.

Treatment:

Other: Placebo

Ibuprofen Capsule

Active Comparator group

Description:

Ibuprofen 400 mg liquid gel capsules, 2 tablets, TID administered with water

Treatment:

Drug: Ibuprofen