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Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

NCT ID: NCT01822665

Last Updated: 2014-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Mucosal Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Paracetamol Tablet

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

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Paracetamol fast dissolving tablets of 500 mg strength

Ibuprofen Tablet

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

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Liquid gelation capsules or tablets of 400 mg strength

Placebo Tablet

Placebo tablets, 2 tablets QID administered with water.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets

Ibuprofen Capsule

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

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Liquid gelation capsules or tablets of 400 mg strength

Interventions

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Ibuprofen

Liquid gelation capsules or tablets of 400 mg strength

Intervention Type DRUG

Paracetamol

Paracetamol fast dissolving tablets of 500 mg strength

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Houston Institute for Clinical Research

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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A1901106

Identifier Type: -

Identifier Source: org_study_id