Trials / Completed
CompletedNCT03472677
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Centrexion Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
A clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Ice Pack and Cooling Device | A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine). |
| DRUG | CNTX-4975-05 (trans-capsaicin) | Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine). |
| DRUG | CNTX-4975-05 (trans-capsaicin) | Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05. |
| DRUG | CNTX-4975-05 (trans-capsaicin) | Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05. |
| DRUG | Capsaicin | Four intradermal injections of capsaicin, two on each forearm. |
Timeline
- Start date
- 2018-03-21
- Primary completion
- 2018-07-27
- Completion
- 2018-08-03
- First posted
- 2018-03-21
- Last updated
- 2018-12-19
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03472677. Inclusion in this directory is not an endorsement.