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

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ClinicalTrials.gov Identifier: NCT02678793
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Tracking Information
First Submitted Date  ICMJE January 18, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date May 9, 2018
Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02678793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
Official Title  ICMJE 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morton's Neuroma
Intervention  ICMJE Drug: CNTX-4975
Study Arms  ICMJE Subjects who have completed Study 4975-MN-202 will be eligible
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.
Intervention: Drug: CNTX-4975
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2018)
67
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2016)
85
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678793
Other Study ID Numbers  ICMJE 4975-MN-203
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centrexion Therapeutics
Study Sponsor  ICMJE Centrexion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centrexion Therapeutics
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP