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

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