Track topics on Twitter Track topics that are important to you
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Crossroads Research, Inc.
Published on BioPortfolio: 2014-08-27T03:52:28-0400
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...
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.
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...
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...
This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore t...
Acoustic neuroma is the most common extra-axial primary cerebellopontine angle tumour in adults. A plethora of studies have been published about acoustic neuroma, but none of the previous works have h...
Neuromas are pathologic nerve distensions caused by a nerve's response to trauma, resulting in a dysfunctional to non-functional nerve. Depending on the severance of the affected nerve, the resulting ...
The painful post amputation neuroma significantly impairs the prosthesis-wearing lower-limb amputee. It remains poorly understood, with literature limited to cohorts of traumatic amputees. This paper ...
Past studies have shown high rates of ocular complications with the need for ophthalmic surgery following acoustic neuroma resection (ANR).
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...
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.
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. ...