MedTrace Logo

Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

NCT01822665 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-03-31

Study results available
· View outcomes & findings →

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.

Conditions

  • Gastrointestinal Mucosal Damage

Interventions

DRUG

Ibuprofen

Liquid gelation capsules or tablets of 400 mg strength

DRUG

Paracetamol

Paracetamol fast dissolving tablets of 500 mg strength

OTHER

Placebo

Placebo tablets

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822665 on ClinicalTrials.gov