HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain - Full Text View

Purpose

Ketaprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: ketaprofen	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Four-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Hisamitsu Pharmaceutical Co., Inc.:

Primary Outcome Measures:

Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days) [ Time Frame: 14 days ± 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

WOMAC: Change from the baseline of the pain subscale score at Visit 5 (Day 7 ±1 day), Visit 7 (Day 21 ±3 days) and Visit 8 (Day 28 ±3 days) [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
Pain Intensity differences at rest, on motion and of overall assessment using a VAS scale at each follow-up assessments time point through Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Subject's Global Assessment at Visit 6 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
Investigator's Global Assessment at Visit 6 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]

Enrollment:	380
Study Start Date:	September 2007
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ketaprofen Treatment with experimental drug	Drug: ketaprofen 2 topical patches applied once daily for 28 days Other Name: Ketaprofen, patch,

Detailed Description:

The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

man or woman ≥45 years of age.
clinical diagnosis of unilateral or bilateral OA of the knee
taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
mild to moderate OA of the knee at the screening visit
subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
subject understands that treatment will be administered on an inpatient basis.
subject is capable of understanding and complying with the protocol and has signed the informed consent document.

Exclusion Criteria:

subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
subject has symptoms that are attributable to primary inflammatory diseases of the joint
subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
subject has arthropathies that occur in conjunction with systemic diseases
subject has a chronic pain condition
subject is grossly obese
subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
subject has a history of osteotomies.
subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments
subject used opioids for OA pain within 1 month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792727

Show 36 Study Locations

Sponsors and Collaborators

Hisamitsu Pharmaceutical Co., Inc.

Investigators

Study Director:

Mr. Kenichi Furuta

Hisamitsu Pharmaceutical Co., Inc.

More Information

No publications provided

Responsible Party:	Mr. Kenichi Furuta, General Manager of International Development Department, Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT00792727 History of Changes
Other Study ID Numbers:	HKT-500-US07
Study First Received:	November 14, 2008
Last Updated:	November 17, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Pain
Knee
Arthritis
Knee pain

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013