Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

NCT00108810 | Completed Phase 2

• 1 other identifier: ZMK-202
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.

Conditions

Pain; Osteoarthritis, Knee

Keywords

Pain; Osteoarthritis; OA; Mild to Moderate Osteoarthritis (OA) Pain of the Knee

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the WOMAC pain subscale score

  28 days

Secondary Outcomes (3)

• Number of participants wih adverse events

  28 days

• Patient Global Satisfaction score

  28 days

• Mean change from baseline for average pain over the last 24 hours VAS scores

  28 days

Study Arms (2)

Transdermal Ketoprofen Patch with CHADD

EXPERIMENTAL

Drug: Transdermal Ketoprofen Patch with CHADD

Placebo patch and a dummy heating unit

PLACEBO COMPARATOR

Drug: Placebo transdermal patch

Interventions

Transdermal Ketoprofen Patch with CHADD DRUG

12 hours patch application for 28 days

Also known as: Matrix Transdermal Ketoprofen/CHADD Sytem

Transdermal Ketoprofen Patch with CHADD

Placebo transdermal patch DRUG

12 hours application for 28 days

Also known as: Placebo patch with dummy heating unit

Placebo patch and a dummy heating unit

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is between forty (40) and seventy-five (75) years of age.
• Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year.

You may not qualify if:

• Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
• Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (5)

SouthBay Pharma Research

Buena Park, California, 90620, United States

Location

The Center for Rheumatology and Bone Research

Washington D.C., District of Columbia, 20006, United States

Location

Radiant Research

Daytona Beach, Florida, 32114, United States

Location

University Clinical Research

Pembroke Pines, Florida, 33024, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David Borenstein, MD

  The Center for Rheumatology

  PRINCIPAL INVESTIGATOR

• H F Farmer, MD

  Radiant Research Inc.

  PRINCIPAL INVESTIGATOR

• Larry Gilderman, DO

  University Clinical Research

  PRINCIPAL INVESTIGATOR

• Soledad Lee, MD

  Southbay Pharma Research

  PRINCIPAL INVESTIGATOR

• Joseph A Markenson, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2005
• First Posted: April 19, 2005
• Study Start: April 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: June 5, 2012

Record last verified: 2012-05

Locations

US (5)