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 range

35 Years – 75 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT03528369

SponsorPropella Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-14

Results submitted2019-12-02

View on ClinicalTrials.gov More Osteoarthritis, Knee trials