Subjects who have completed study 4975-MN-202 will be eligible to receive open-label treatment with CNTX-4975 200 µg in study 4975-MN-203 if they meet the inclusion/exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Arizona Research Center
Phoenix, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Evaluate the safety and tolerability of repeat injections of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events
Time frame: over the course of 1 year.
Evaluate the safety and tolerability of repeat injections of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests
Time frame: over the course of 1 year.
To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in NPRS.
Time frame: over the course of 1 year.
To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in Patient Global Impression of Change
Time frame: over the course of 1 year.
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Chesapeake Research Group
Pasadena, Maryland, United States
Center for Advanced Medicine & Research
City of Saint Peters, Missouri, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Allcare Foot and Ankle Centre
Arlington, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States