Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

NCT00219700 | Completed Phase 2

• 1 other identifier: PL-IB-002
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis

Keywords

NSAID-PC; IBU-PC

Outcome Measures

Primary Outcomes (1)

• Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.

Secondary Outcomes (1)

• WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.

Interventions

Ibuprofen-PC DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• PLx Pharma: lead
• National Institutes of Health (NIH): collaborator
• Texas Higher Education Coordinating Board: collaborator

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: November 26, 2008

Record last verified: 2008-11