A Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal… (NCT02283957) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
United States119 participantsStarted 2014-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female aged \>18 years at the time of the Screening Visit.
✓. Pain associated with intermetatarsal neuroma (Morton's neuroma) for a minimum of 3 months prior to Screening.
✓. Diagnosis of Morton's neuroma, confirmed by evidence of focal tenderness and pain in the distal third intermetatarsal space, AND either
✓. A mean neuroma foot pain score of 4 or greater during the 7 days prior to dosing (NPRS, 0-10) as rated daily at bedtime (9:00 PM ± 3 hours) for average pain with walking in the last 24-hours. At least 5 of 7 scores during the week prior to dosing must be recorded.
✓. Tried conservative treatment with analgesics (acetaminophen or nonsteroidal anti-inflammatory drugs) and non-pharmacologic therapy (such as wide shoes, orthotics, and/or arch supports) without complete success.
✓. 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:
✓. Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and daily IWRS/IVRS entries, and to communicate meaningfully with the study personnel.
What they're measuring
1
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS
Timeframe: Baseline (mean of Day -7 through Day -1), to week 4 (mean of Day 22 through Day 28)
. Signed an Informed Consent Form approved by the Institutional Review Board.
Exclusion criteria
✕. Clinically significant bursitis in either foot.
✕. The subject has more than one painful intermetatarsal neuroma in the affected foot which, in the opinion of the Investigator, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma in the affected foot.
✕. Radiography within 6 months of the Treatment Visit (Day 1) to exclude musculoskeletal pathology must be performed, to include any osseous abnormality such as stress fracture, osteophyte, tumor, or cyst in the bones or toes adjacent to the third inter-metatarsal space or any significant evidence of arthritis in the joints of the 3rd and 4th metatarsal-phalangeal joints or inter-phalangeal joints of the 3rd and 4th toes.
✕. Previous neurectomy in the same nerve.
✕. Any painful condition or prior surgery on the affected ankle or foot, which, in the judgment of the investigator, might adversely impact the interpretation of study data.
✕. Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis etc.) or evidence of clinically meaningful ischemia which, in the judgment of the investigator and the medical monitor, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma.
✕. Other chronic pain anywhere in the body that is greater than or equal to the intensity of foot pain from intermetatarsal neuroma.
✕. Signs of arterial insufficiency in the feet, including clinically meaningful edema.