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

• Sponsor: Hisamitsu Pharmaceutical Co., Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00792727
• Collaborator: (none)
• Enrollment: 380
• Locations: 36
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 10.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Drug: ketoprofen Patch; Other: Placebo Patch	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 380 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketoprofen Patch Treatment with experimental drug	Drug: ketoprofen Patch; 2 topical patches applied once daily for 28 days; Other Names: Ketoprofen topical patch
Placebo Comparator: Placebo Patch Treatment with placebo drug	Other: Placebo Patch; 2 topical placebo patches applied once daily for 28 days; Other Names: Sham Treatment

Outcome Measures

Primary Outcome Measures

1. Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days) [14 days ± 2 days]

Secondary Outcome Measures

1. 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) [28 days (±3 days)]

2. WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8 [28 days (±3 days)]

3. WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8 [28 days (±3 days)]

4. 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. [28 days]

5. Subject's Global Assessment at Visit 6 and Visit 8 [28 days (±3 days)]

6. Investigator's Global Assessment at Visit 6 and Visit 8 [28 days (±3 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hisamitsu Investigator Site	Birmingham	Alabama	United States	35242
2	Hisamitsu Investigator Site	Chandler	Arizona	United States	85225
3	Hisamitsu Investigator Site	Peoria	Arizona	United States	85381
4	Hisamitsu Investigator Site	San Diego	California	United States	92108
5	Hisamitsu Investigator Site	Colorado Springs	Colorado	United States	80910
6	Hisamitsu Investigator Site	Denver	Colorado	United States	80204
7	Hisamitsu Investigator Site	Denver	Colorado	United States	80209
8	Hisamitsu Investigator Site	Daytona Beach	Florida	United States	32117
9	Hisamitsu Investigator Site	Delray Beach	Florida	United States	33484
10	Hisamitsu Investigator Site	Fort Myers	Florida	United States	33916
11	Hisamitsu Investigator Site	Pembroke Pines	Florida	United States	33024
12	Hisamitsu Investigator Site	Evansville	Indiana	United States	47714
13	Hisamitsu Investigator Site	Crestview Hills	Kentucky	United States	41017
14	Hisamitsu Investigator Site	Fall River	Massachusetts	United States	02720
15	Hisamitsu Investigator Site	Omaha	Nebraska	United States	68114
16	Hisamitsu Investigator Site	Las Vegas	Nevada	United States	89104
17	Hisamitsu Investigator Site	Reno	Nevada	United States	89502
18	Hisamitsu Investigator Site	Albuquerque	New Mexico	United States	87102
19	Hisamitsu Investigator Site	Greensboro	North Carolina	United States	27401
20	Hisamitsu Investigator Site	Bismark	North Dakota	United States	58503
21	Hisamitsu Investigator Site	Cincinnati	Ohio	United States	45227
22	Hisamitsu Investigator Site	Columbus	Ohio	United States	43212
23	Hisamitsu Investigator Site	Mogadore	Ohio	United States	44260
24	Hisamitsu Investigator Site	Zanesville	Ohio	United States	43701
25	Hisamitsu Investigator Site	Oklahoma City	Oklahoma	United States	73109
26	Hisamitsu Investigator Site	Tulsa	Oklahoma	United States	74136
27	Hisamitsu Investigator Site	Warwick	Rhode Island	United States	02886
28	Hisamitsu Investigator Site	Anderson	South Carolina	United States	29621
29	Hisamitsu Investigator Site	Austin	Texas	United States	78752
30	Hisamitsu Investigator Site	San Antonio	Texas	United States	78217
31	Hisamitsu Investigator Site	San Antonio	Texas	United States	78232
32	Hisamitsu Investigator Site	Salt Lake City	Utah	United States	84107
33	Hisamitsu Investigator Site	Arlington	Virginia	United States	22205
34	Hisamitsu Investigator Site	Charlottesville	Virginia	United States	22911
35	Hisamitsu Investigator Site	Newport News	Virginia	United States	23606
36	Hisamitsu Investigator Site	Yakima	Washington	United States	98902

Sponsors and Collaborators

• Hisamitsu Pharmaceutical Co., Inc.

Investigators

• Study Director: Mr. Kenichi Furuta, Hisamitsu Pharmaceutical Co., Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
• ClinicalTrials.gov Identifier: NCT00792727
• Other Study ID Numbers: HKT-500-US07
• First Posted: Nov 18, 2008
• Last Update Posted: Jun 4, 2015
• Last Verified: May 1, 2015

• Keywords provided by Hisamitsu Pharmaceutical Co., Inc.: Pain; Knee; Arthritis; Knee pain
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Ketoprofen

Study Results

No Results Posted as of Jun 4, 2015