Completed

NCT Number: NCT01822665

Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

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.

Completed

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Key information

Conditions

Gastrointestinal Mucosal Damage

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

Liquid gelation capsules or tablets of 400 mg strength

Paracetamol

Drug

Paracetamol fast dissolving tablets of 500 mg strength

Placebo

Other

Placebo tablets

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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

Time frame: 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 Gastric and/or Duodenal Mucosal Injury

Time frame: 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.
Incidence of Fecal Occult Blood

Time frame: Day 7

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Apr 2, 2013
Registry last updated: Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.