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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
119
Arizona Research Center
Phoenix, Arizona, United States
Premier Research
Phoenix, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Center for Clinical Research, Inc
Castro Valley, California, United States
eStudySite, La Mesa
La Mesa, California, United States
TriWest Research Associates
La Mesa, California, United States
Chesapeake Research Group, LLC
Pasadena, Maryland, United States
Center for Advanced Medicine and Research
City of Saint Peters, Missouri, United States
University Orthopedics Center- Altoona
Altoona, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
...and 6 more locations
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS in subjects treated with CNTX-4975 compared with placebo.
Time frame: 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
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).
Time frame: 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)
Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary) using NPRS (mean of daily pain scores for each week).
Time frame: Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12
Area under the curve (AUC) for average neuroma foot pain (Diary)
Area under the curve (AUC) for average neuroma foot pain (Diary) with walking (NPRS).
Time frame: Baseline (mean of Day -7 through Day -1), to Week 12
Foot Function measured by FFI-R-R
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.
Time frame: Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)
QOL as measured by the EQ-5D.
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.
Time frame: Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12)
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