Effect of injection site cooling in treatment of OA knee
Research type
Research Study
Full title
A Phase 1b Study to Characterize the Effect of Injection Site Cooling on Pain Experienced after CNTX-4975-05 (Trans-capsaicin) Intra-articular and Capsaicin Intradermal Injections in Healthy Volunteers and Subjects with Bilateral Painful Knee Osteoarthritis.
IRAS ID
241297
Contact name
David Ball
Contact email
Sponsor organisation
Centrexion Therapeutics
Eudract number
2017-004266-10
Duration of Study in the UK
0 years, 3 months, 21 days
Research summary
Centrexion Therapeutics Corp are sponsoring a trial to research the active ingredient in the study drug CNTX-4975 05, capsaicin. Capsaicin is the substance in chili peppers that makes them taste hot. CNTX-4975-05 is designed to provide pain relief for weeks to months after a single injection into the knee joint.
This study is investigating two knee joint cooling methods in healthy volunteers initially, to determine how the temperature varies within the knee joint using the two cooling methods. Healthy volunteers will not receive injection of the study compound. The results from this cohort will guide the use of cooling and timing of measurements in the later cohorts of the trial.
In later cohorts, the study will investigate the effect of injection site cooling on the pain experienced after injections of CNTX-4975-05 (synthetic capsaicin) into the knees of subjects with moderate to severe painful osteoarthritis of the knee (OA knee).
The effect of injection site cooling on the pain experienced after injection of capsaicin in the skin of the forearms is also being investigated.
Subject's participation in the trial will last approximately 60 days (up to a maximum of 72 days) and subjects will be required to attend the Manchester Clinic for 6 outpatient visits in Cohort 1 and 7 outpatient visits for Cohorts 2-4. The visits will take place at the MAC Clinical Research Unit located in Manchester. As part of this study, participants will undergo physical and neurological assessments, blood and urine sampling for laboratory analysis, ECGs, rating scales and questions relating to pain and imaging of both knees (X-rays) if required (OA knee patients only). Study specific on-site assessments will be completed by a qualified clinician. Some of these assessments at the beginning of the study will determine if a subject is eligible to participate.
REC name
Wales REC 1
REC reference
18/WA/0017
Date of REC Opinion
1 Mar 2018
REC opinion
Further Information Favourable Opinion