Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

Phase 4

Completed

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 conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ibuprofen Tablet	Ibuprofen	Ibuprofen 400 mg tablet, 2 tablets administered three times a day (TID) with water
Ibuprofen Capsule	Ibuprofen	Ibuprofen 400 mg liquid gel capsules, 2 tablets, TID administered with water
Paracetamol Tablet	Paracetamol	Paracetamol 500 mg tablet, 2 tablets administered 4 times a day (QID) with water.
Placebo Tablet	Placebo	Placebo tablets, 2 tablets QID administered with water.

Primary Outcome Measures

Name	Time	Method
Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule	Day 7	Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.

Secondary Outcome Measures

Name	Time	Method
Incidence of Gastric and/or Duodenal Mucosal Injury	Day 7	Number of participants with endoscopy score equal to or more than 2 were determined based on Lanza score for both gastric and duodenal mucosal damage.
GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet	Day 7	Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.
Duodenal Mucosal Damage (DMD) Scores	Day 7	DMD was measured using a 5- point Lanza scale: 0 - normal duodenum; 1 - mucosal hemorrhages; 2 - one or two erosions; 3 - numerous areas of erosions and 4 - more than 10 erosions/ ulcers.
Incidence of Fecal Occult Blood	Day 7	The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood).