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| ID | Type | Description | Link |
|---|---|---|---|
| Ketoprofen Topical Patch, 20% |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Single Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketoprofen Topical Patch 20% | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 consecutive days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 consecutive days | |
| Assess the time to first perceptible pain relief | 3 consecutive days |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Research Institute, LLC | Phoenix | Arizona | 85050 | United States | ||
| CPI, Clinical Research Atlanta |
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| 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. | 3 consecutive days |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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