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

NCT00792727 | Completed Phase 3

• 1 other identifier: HKT-500-US07
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 36

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.

Conditions

Osteoarthritis of the Knee

Keywords

Pain; Knee; Arthritis; Knee pain

Outcome Measures

Primary Outcomes (1)

• Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days)

  14 days ± 2 days

Secondary Outcomes (6)

• 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)

• 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)

• WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8

  28 days (±3 days)

• 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

• Subject's Global Assessment at Visit 6 and Visit 8

  28 days (±3 days)

Study Arms (2)

Ketoprofen Patch

EXPERIMENTAL

Treatment with experimental drug

Drug: ketoprofen Patch

Placebo Patch

PLACEBO COMPARATOR

Treatment with placebo drug

Other: Placebo Patch

Interventions

ketoprofen Patch DRUG

2 topical patches applied once daily for 28 days

Also known as: Ketoprofen topical patch

Ketoprofen Patch

Placebo Patch OTHER

2 topical placebo patches applied once daily for 28 days

Also known as: Sham Treatment

Placebo Patch

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hisamitsu Pharmaceutical Co., Inc.: lead

Study Sites (36)

Hisamitsu Investigator Site

Birmingham, Alabama, 35242, United States

Location

Hisamitsu Investigator Site

Chandler, Arizona, 85225, United States

Location

Hisamitsu Investigator Site

Peoria, Arizona, 85381, United States

Location

Hisamitsu Investigator Site

San Diego, California, 92108, United States

Location

Hisamitsu Investigator Site

Colorado Springs, Colorado, 80910, United States

Location

Hisamitsu Investigator Site

Denver, Colorado, 80204, United States

Location

Hisamitsu Investigator Site

Denver, Colorado, 80209, United States

Location

Hisamitsu Investigator Site

Daytona Beach, Florida, 32117, United States

Location

Hisamitsu Investigator Site

Delray Beach, Florida, 33484, United States

Location

Hisamitsu Investigator Site

Fort Myers, Florida, 33916, United States

Location

Hisamitsu Investigator Site

Pembroke Pines, Florida, 33024, United States

Location

Hisamitsu Investigator Site

Evansville, Indiana, 47714, United States

Location

Hisamitsu Investigator Site

Crestview Hills, Kentucky, 41017, United States

Location

Hisamitsu Investigator Site

Fall River, Massachusetts, 02720, United States

Location

Hisamitsu Investigator Site

Omaha, Nebraska, 68114, United States

Location

Hisamitsu Investigator Site

Las Vegas, Nevada, 89104, United States

Location

Hisamitsu Investigator Site

Reno, Nevada, 89502, United States

Location

Hisamitsu Investigator Site

Albuquerque, New Mexico, 87102, United States

Location

Hisamitsu Investigator Site

Greensboro, North Carolina, 27401, United States

Location

Hisamitsu Investigator Site

Bismarck, North Dakota, 58503, United States

Location

Hisamitsu Investigator Site

Cincinnati, Ohio, 45227, United States

Location

Hisamitsu Investigator Site

Columbus, Ohio, 43212, United States

Location

Hisamitsu Investigator Site

Mogadore, Ohio, 44260, United States

Location

Hisamitsu Investigator Site

Zanesville, Ohio, 43701, United States

Location

Hisamitsu Investigator Site

Oklahoma City, Oklahoma, 73109, United States

Location

Hisamitsu Investigator Site

Tulsa, Oklahoma, 74136, United States

Location

Hisamitsu Investigator Site

Warwick, Rhode Island, 02886, United States

Location

Hisamitsu Investigator Site

Anderson, South Carolina, 29621, United States

Location

Hisamitsu Investigator Site

Austin, Texas, 78752, United States

Location

Hisamitsu Investigator Site

San Antonio, Texas, 78217, United States

Location

Hisamitsu Investigator Site

San Antonio, Texas, 78232, United States

Location

Hisamitsu Investigator Site

Salt Lake City, Utah, 84107, United States

Location

Hisamitsu Investigator Site

Arlington, Virginia, 22205, United States

Location

Hisamitsu Investigator Site

Charlottesville, Virginia, 22911, United States

Location

Hisamitsu Investigator Site

Newport News, Virginia, 23606, United States

Location

Hisamitsu Investigator Site

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Arthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Mr. Kenichi Furuta

  Hisamitsu Pharmaceutical Co., Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 18, 2008
• Study Start: September 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 4, 2015

Record last verified: 2015-05

Locations

US (36)