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A Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00903994
First received: May 15, 2009
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

Open-label study to be conducted at 2 US investigational sites in subjects who have acute tendonitis or bursitis of the shoulder, elbow, or knee. Eligible subjects receive treatment with the KTP, applied once daily at the same application site for 3 consecutive days.


Condition Intervention Phase
Tendonitis of the Shoulder, Elbow, or Knee
Drug: Ketoprofen Topical Patch 20%
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: An Open-Label, Phase II, Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • To measure the time to onset of action of the KTP in the treatment of pain associated with acute tendonitis or bursitis of the shoulder, elbow, or knee as measured by the time to meaningful pain relief. [ Time Frame: 3 consecutive days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of the KTP as measured by adverse events cutaneous AEs, assessments of local tolerability and patch adherence, and vital signs [ Time Frame: 3 consecutive days ] [ Designated as safety issue: Yes ]
  • Assess the time to first perceptible pain relief [ Time Frame: 3 consecutive days ] [ Designated as safety issue: No ]
  • Assess the effect of KTP in the treatment of pain associated with acute tendonitis or bursitis of the shoulder, elbow or knee as measured by pain intensity during activity and pain relief. [ Time Frame: 3 consecutive days ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
Single Arm
Drug: Ketoprofen Topical Patch 20%
Ketoprofen is a pressure-sensitive adhesive material containing 20% Ketoprofen which is applied to a polyester textile and covered with a foil release liner.for the treatment of mild to moderate acute pain associated with Tendonitis or Bursitis of the shoulder, elbow or knee

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are males or females 18 years of age or older (If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all females are considered to be of childbearing potential unless they are post-menopausal, biologically sterile, or surgically sterile (i.e., hysterectomy, bilateral oophorectomy), or have undergone tubal ligation for greater than or equal to one year.)
  • Have a diagnosis of acute tendonitis or bursitis of the shoulder, elbow or knee with acute onset of the current episode in the 15 days preceding the screening visit
  • Have average pain intensity during daily activities over the past 24 hours rated 5 or greater on an 11-point scale (range 0 to 10). (If the onset of acute tendonitis or bursitis is less than 24 hours before the screening visit, the patient will rate the average pain intensity during daily activity since the time of onset.) Site personnel must not reveal this eligibility criterion to prospective patients.
  • Are willing to discontinue use of all analgesic medications (including over-the-counter [OTC] analgesics) except the study patch. Note: Aspirin at a daily dose of 81 mg per day for cardiovascular prophylaxis will be allowed.
  • Have been informed of the nature of the study and have provided written informed consent

Exclusion Criteria:

  • Have a positive urine pregnancy test (females of childbearing potential only) or are pregnant or lactating
  • Have tendonitis or bursitis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis, spondyloarthropathies), or resulting from calcification or requiring surgery
  • Have had pharmacologic treatment (e.g., analgesic medications except 81mg prophylactic aspirin) less than 12 hours before the baseline assessments
  • Have received systemic corticosteroids in the 30 days preceding the screening visit (e.g., intra-articular, peritendinous, oral, or parenteral administration). Nasal inhalation steroids are permitted.
  • Have received any pharmacologic treatment or physical therapy in the past 6 months for the joint targeted for this study. Pharmacologic treatment or physical therapy for current tendonitis or bursitis is allowed unless the medication or therapy is prohibited by the protocol.
  • Require continued use of an immobilization device for treatment of the current episode of tendonitis or bursitis
  • Have a history or physical examination finding that is incompatible with safe participation in the study, including GI ulcer or bleeding, anemia or prolonged bleeding time
  • Have a history, or physical examination finding, that is incompatible with study product use or with obtaining robustly interpretable data, chronic skin conditions such as psoriasis, clinically significant osteoarthritis, or skin lesions or wounds at the affected site
  • Have a history of drug or alcohol abuse
  • Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. This includes:

    • patients with allergies to prescription or OTC products containing NSAIDs
    • patients in whom aspirin or other NSAIDs or analgesic drugs induce the syndrome of asthma, rhinitis and nasal polyps
    • patients taking medications that may affect clotting, for example warfarin, parenteral heparin, ticlopidine (Ticlid®) or clopidogrel (Plavix®)
    • patients taking lithium
    • patients taking methotrexate
  • Are renally or hepatically impaired in the judgment of the investigator based on the patient's medical history or other available clinical laboratory information
  • Are taking sleep medications, muscle relaxants, anticonvulsants or antidepressants at a dose that has not been stable for at least 3 months
  • Receiving physical therapy for the tendonitis/bursitis. Ongoing, stable physical therapy for conditions not related to tendonitis/bursitis is allowed.
  • Have scheduled elective surgery or other invasive procedures during the period of study participation
  • Have any illness or concurrent condition that would, in the opinion of the investigator or medical monitor, make study participation unsafe or would confound study results (e.g.,inflammatory arthritis, spondyloarthropathies, fibromyalgia, or are currently undergoing treatment for chronic pain)
  • Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903994

Locations
United States, Arizona
HOPE Research Institute, LLC
Phoenix, Arizona, United States, 85050
United States, Georgia
CPI, Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00903994     History of Changes
Other Study ID Numbers: EN3269-201, Ketoprofen Topical Patch, 20%
Study First Received: May 15, 2009
Last Updated: May 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Acute Pain

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Ketoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014