ALGRX 4975 in the Treatment of Patients With Morton's Neuroma

2014-08-27 03:52:28 | BioPortfolio


Subjects will have painful primary or post-operative intermetatarsal neuroma. Study drug or placebo will be injected into the space containing the neuroma. Subjects will complete weekly assessments for severity of foot pain, a brief pain inventory, and the amount of pain medication taken. Subjects will be seen for a screening visit, a treatment visit, and two follow-up visits after treatment. The last scheduled visit is one month after treatment. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment.


Subjects will have painful primary or post-operative intermetatarsal neuroma. Each subject will be randomly allocated to receive either ALGRX 4975 or placebo in a 1:1 ratio. Study drug or placebo will be injected into the intermetatarsal space containing a painful neuroma. Subjects will complete weekly assessments for the Average Foot Pain Severity, the 7 Interference Items of the BPI, and the number of analgesic units taken. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment.

Plasma concentrations will be assessed pre-dose and post dose at 5, 10, 15, 20, 30, and 45 min and at 1, 1.5, 2, 2.5, 3 and 4 hours.

Safety will be assessed at baseline and during the study with adverse events (all visits), vital signs (Visit 2 pre and post-injection and Visit 3 or at early termination), and laboratory assessments (hematology, chemistry, urinalysis) and ECG (Screening and Visit 3 or at early termination). The injection site will be examined and assessed by a 6-point scale for erythema, edema, and hemorrhage before the injection and at 1, 2 and 4 hours after the injection. A pain on injection NRS will be assessed immediately post- injection at 15, 30, and 45 minutes and 1, 2, 3, and 4 hours after study drug administration. A sensory examination of the foot will be performed before the injection and 4 hours after the injection and at the completion of the study. If a subject has injection pain, the foot may be wrapped in ice for up to 20 minutes, analgesic medication may be provided.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment




ALGRX 4975


Crossroads Research, Inc.
Owings Mills
United States




AlgoRx Pharmaceuticals

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:52:28-0400

Clinical Trials [28 Associated Clinical Trials listed on BioPortfolio]

ALGRX 4975 in the Treatment of Tennis Elbow

Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to reduc...

An 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.

Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal

Postoperative pain after gall bladder removal can be significant, mobility limiting and extend hospital stay. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that h...

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

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...

Study of ALGRX 3268 for Needlestick Pain in Children

Minor needlestick procedures often cause significant pain and distress in children, yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, ne...

PubMed Articles [21 Associated PubMed Articles listed on BioPortfolio]

Prediction of Clinical Prognosis according to Intermetatarsal Distance and Neuroma Size on Ultrasonography in Morton Neuroma: A Prospective Observational Study.

This study aims to evaluate the clinical importance of intermetatarsal distance, size of neuroma, and proportion of neuroma in the intermetatarsal space in examinations of Morton neuroma using ultraso...

Trough-Shaped Audiograms Are Common in Patients with Acoustic Neuroma and Sudden Sensorineural Hearing Loss.

Acoustic neuroma sometimes presents with sudden-onset sensorineural hearing loss as a primary symptom. We investigated 848 untreated cases that included 20 cases with acoustic neuroma with sudden-onse...

Traumatic Neuroma With Melanoma Perineural Invasion.

Traumatic neuroma is a reactive non-neoplastic neural proliferation that results from trauma. Although such type of lesions found surgical scars due to different reasons, its involvement by residual o...

Time course of traumatic neuroma development.

This study was designed to characterize morphologic stages during neuroma development post amputation with an eye toward developing better treatment strategies that intervene before neuromas are fully...

Dorsal suspension for Morton's neuroma: A comparison with neurectomy.

The purpose of this study was to investigate and compare the clinical outcomes of dorsal suspension with those of neurectomy for the treatment of Morton's neuroma.

Medical and Biotech [MESH] Definitions

A tumor made up of nerve cells and nerve fibers. (Dorland, 27th ed)

A nerve inflammation in the foot caused by chronic compression of the plantar nerve between the METATARSAL BONES.

A benign SCHWANNOMA of the eighth cranial nerve (VESTIBULOCOCHLEAR NERVE), mostly arising from the vestibular branch (VESTIBULAR NERVE) during the fifth or sixth decade of life. Clinical manifestations include HEARING LOSS; HEADACHE; VERTIGO; TINNITUS; and FACIAL PAIN. Bilateral acoustic neuromas are associated with NEUROFIBROMATOSIS 2. (From Adams et al., Principles of Neurology, 6th ed, p673)

Pathological processes of the VESTIBULOCOCHLEAR NERVE, including the branches of COCHLEAR NERVE and VESTIBULAR NERVE. Common examples are VESTIBULAR NEURITIS, cochlear neuritis, and ACOUSTIC NEUROMA. Clinical signs are varying degree of HEARING LOSS; VERTIGO; and TINNITUS.

More From BioPortfolio on "ALGRX 4975 in the Treatment of Patients With Morton's Neuroma"

Quick Search


Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Searches Linking to this Trial