Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-11-30

Brief Summary

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To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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NSAID-PC IBU-PC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Ibuprofen-PC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* moderate osteoarthritis in the hip and/or knee requiring chronic pain medication
* others per protocol

Exclusion Criteria

* sensitivity to NSAIDs and lecithin
* hypertension
* history of GI and other specific problems
* use of medications and other criteria per the protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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PLx Pharma

Other Identifiers

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PL-IB-002

Identifier Type: -

Identifier Source: org_study_id