Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
APR Applied Pharma Research s.a.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
