Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

GlaxoSmithKline28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gastrointestinal Mucosal Damage

Interventions

IbuprofenDRUG

Liquid gelation capsules or tablets of 400 mg strength

ParacetamolDRUG

Paracetamol fast dissolving tablets of 500 mg strength

PlaceboOTHER

Placebo tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Houston Institute for Clinical Research

Houston, Texas, United States

Outcomes

Primary Outcomes

Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule

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.

Time frame: Day 7

Secondary Outcomes

GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet

Time frame: Day 7

Duodenal Mucosal Damage (DMD) Scores

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.

Time frame: Day 7

Incidence of Gastric and/or Duodenal Mucosal Injury

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.

Time frame: Day 7

Incidence of Fecal Occult Blood

The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood).

Time frame: Day 7

Data from ClinicalTrials.gov

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