Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219700

Enrollment

125

Registered

2005-09-22

Start date

2005-01-31

Completion date

2005-11-30

Last updated

2008-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

NSAID-PC, IBU-PC

Brief summary

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

Interventions

DRUGIbuprofen-PC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.	—

Secondary

Measure	Time frame
WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026