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



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:5/11/2018
Start Date:December 2015
End Date:March 2017

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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)

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.


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.
We found this trial at
10
sites
Jonesboro, Arkansas 72401
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
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Lynchburg, VA
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8028 Ritchie Highway
Pasadena, Maryland 21122
443-557-0374
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Altoona, Pennsylvania 16602
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Arlington, Texas 76015
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Arlington, TX
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El Cajon, California 92020
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Phoenix, Arizona 85023
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Phoenix, AZ
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2730 South Saint Peters Parkway
Saint Peters, Missouri 63303
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Saint Peters, MO
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Salt Lake City, Utah 84107
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Salt Lake City, UT
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State College, Pennsylvania 16801
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State College, PA
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