Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

PLx Pharma

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Ibuprofen-PC

Study type: Interventional

Funder types: Industry; Other; NIH

Identifiers

NCT00219700

PL-IB-002

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind