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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT00792727
First received: November 14, 2008
Last updated: August 18, 2014
Last verified: August 2014

November 14, 2008
August 18, 2014
September 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00792727 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoarthritis of the Knee
Drug: ketaprofen
2 topical patches applied once daily for 28 days
Other Name: Ketaprofen, patch,
Experimental: Ketaprofen
Treatment with experimental drug
Intervention: Drug: ketaprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
May 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00792727
HKT-500-US07
No
Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
Not Provided
Study Director: Mr. Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP