A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-… (NCT03528369) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control
United States122 participantsStarted 2018-05-14
Plain-language summary
This is a multi-center, randomized, double-blind clinical trial to examine the comparative effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content) (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied at the clinic for 60 minutes on each of four consecutive days.
Who can participate
Age range35 Years – 75 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:
* Osteoarthritis (OA) of both knees;
* OA of both knees must be confirmed by tibiofemoral joint radiographs obtained within the past 6 months;
* Rheumatoid factor (RF) negative and Erythrocyte sedimentation rate (ESR) \<40 mm/hr;
* Chronic knee pain in at least 1 knee for \> 3 months;
* WOMAC pain score of \> 250 (using VAS WOMAC format) at screening, and at baseline, in at least one knee;
* Knee pain score of \> 5 on the NRS pain scale at screening, and at baseline, in at least one knee;
* Knee pain is not potentially due to acute trauma unrelated to OA (no acute traumatic knee injury in medical history);
* No burning-stinging pain, unrelated to subject's knee pain, at intended site of application;
* Knee pain must be greater than pain in any other part of subject's body;
* American College of Rheumatology (ACR) global functional status I, II, or III (excluding IV).
Exclusion Criteria:
* Spontaneously improving or rapidly deteriorating OA of the knee;
* Rheumatoid or psoriatic arthritis, or a form of arthritis (e.g. gout, pseudogout), Paget's disease of bone, or any other disease affecting the joints that are inconsistent with a diagnosis of idiopathic OA;
* Labile or poorly controlled hypertension;
* Use of steroids for 1 month prior to screening, or intraarticular-visco-supplementation within 3 months prior to screening;
* Used any capsaicin-containing product on or in the vicinity of the knee within 4 weeks prior to screening;
* Used topically appli…
What they're measuring
1
Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35
Timeframe: 35 days after the last dose of study drug on Day 4