A Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With T… (NCT00903994) | Clinical Trial Compass
CompletedPhase 2
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
United States17 participantsStarted 2007-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
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.