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A Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma) | Clinical Trials | Clareo Health

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A Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)

An Open-Label, Multiple-Dose Extension Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)

NCT02678793•Centrexion Therapeutics

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female aged \>18 years at the time of the Screening Visit.
•2. Completion of study 4975-MN-202.
•3. Female not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing one of the following medically acceptable methods of birth control throughout the study period:
•1. Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before investigational product (IP) administration.
•2. Total abstinence from sexual intercourse since the last menses before IP administration.
•3. Intrauterine device.
•4. Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream).
•4. Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and weekly IWRS/IVRS entries, and to communicate meaningfully with the study personnel.
•5. Signed an Informed Consent Form approved by the Institutional Review Board.
•6. Subject agrees to take only the rescue medications for neuroma foot pain from the time of screening through study completion, and agrees to discontinue all topical medications for neuroma pain after Screening.

Exclusion Criteria

•1. Other chronic pain anywhere in the body that is severe in intensity or would interfere with the subject's ability to evaluate foot pain from intermetatarsal neuroma.
•2. Signs of arterial insufficiency in the feet, including clinically meaningful edema.
•3. Raynaud's disease or phenomenon, previous frostbite, or other cause of vascular instability in the feet resulting from application of cold to the foot.
•4. Daily use of opioids for any condition.
•5. Corticosteroid injection in the affected foot within 30 days of Screening.
•6. Presence of any medical condition (or taking any medication) or unstable health status that, in the judgment of the investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease.
•7. Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator).
•8. Has a positive pregnancy test at the Screening Visit.

Locations (10)

Arizona Research Center

Phoenix, Arizona, United States

NEA Baptist Clinic

Jonesboro, Arkansas, United States

TriWest Research Associates, LLC

El Cajon, California, United States

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

Key Dates

Start Date

December 1, 2015

Primary Completion Date

December 1, 2016

Completion Date

March 1, 2017

Last Updated

May 9, 2018

Enrollment

ACTUAL participants

Conditions

Morton's Neuroma

Interventions

CNTX-4975

DRUG

Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain

NCT05695339

Morton's Neuroma

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COMPLETEDNA

Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

NCT03940963

Symptomatic NeuromaMorton's Neuroma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)

Inclusion Criteria

Exclusion Criteria

Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain

Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma