A Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
- Conditions
- Painful Intermetatarsal Neuroma (Morton's Neuroma)
- Interventions
- Other: Placebo
- Registration Number
- NCT02283957
- Lead Sponsor
- Centrexion Therapeutics
- Brief Summary
Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo injected into the intermetatarsal space around a Morton's neuroma. The injection of study medication will be administered by ultrasound-guided needle placement following ankle block anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects will return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 mL injection of 200 µg of CNTX-4975 CNTX-4975 Single dose, 2 mL 2 mL injection of 600 µg of CNTX-4975 CNTX-4975 Single dose, 2 mL 2 mL injection of placebo Placebo Single dose, 2 mL 2 mL injection of 25 µg of CNTX-4975 CNTX-4975 Single dose, 2 mL
- Primary Outcome Measures
Name Time Method Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS Baseline (mean of Day -7 through Day -1), to week 4 (mean of Day 22 through Day 28) Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS in subjects treated with CNTX-4975 compared with placebo.
- Secondary Outcome Measures
Name Time Method Change from Baseline in average neuroma foot pain (Diary) with walking Baseline (mean of Day -7 through Day -1), Week 1 through Week 12 Change from Baseline during the Follow-up Period in average neuroma foot pain (Diary) with walking using NPRS (mean of daily pain scores for each week).
Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12 Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) using NPRS (mean of daily pain scores for each week).
Foot Function measured by FFI-R-R Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) Change from Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) in foot function as measured by the FFI-R-R.
Area under the curve (AUC) for average neuroma foot pain (Diary) Baseline (mean of Day -7 through Day -1), to Week 12 Area under the curve (AUC) for average neuroma foot pain (Diary) with walking (NPRS).
QOL as measured by the EQ-5D. Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) Change from Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12) in QOL as measured by the EQ-5D.
Trial Locations
- Locations (15)
eStudySite, La Mesa
🇺🇸La Mesa, California, United States
Chesapeake Research Group, LLC
🇺🇸Pasadena, Maryland, United States
University Orthopedics Center- Altoona
🇺🇸Altoona, Pennsylvania, United States
The Education and Research Foundation
🇺🇸Lynchberg, Virginia, United States
TriWest Research Associates
🇺🇸La Mesa, California, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Premier Research
🇺🇸Austin, Texas, United States
Center for Advanced Medicine and Research
🇺🇸St. Peters, Missouri, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
Allcare Foot and Ankle Center
🇺🇸Arlington, Texas, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Center for Clinical Research, Inc
🇺🇸Castro Valley, California, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Endeavor Clinical Trials, PA
🇺🇸San Antonio, Texas, United States