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Pacific time) to report results of the Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.
The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN.
The purpose of the interim analysis was to allow for a sample size adjustment if necessary to maintain appropriate statistical power to detect a treatment effect between Clonidine Topical Gel and placebo.
BDSI met with representatives of the FDA on November 21, 2013 to discuss the proposed clinical development program for Clonidine Topical Gel for the treatment of PDN.
On April 3, 2014, BDSI announced the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN).
The intent of the study will be to demonstrate the efficacy and safety of Clonidine Topical Gel for the treatment of PDN.
The Phase 3 trial is a multicenter, randomized, double blind, placebo controlled study to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with painful diabetic neuropathy.
In addition to the progress on its two buprenorphine containing products, BDSI expanded its product portfolio in 2013 by in-licensing Clonidine Topical Gel, a proposed treatment for painful diabetic neuropathy.
Clonidine Topical Gel Phase 3 program enrollment anticipated to begin first quarter
Food and Drug Administration (FDA) regarding the clinical development program for Clonidine Topical Gel that will allow the program to proceed to Phase 3 clinical studies in the first quarter of 2014.
Over-the-counter topical gel stops nosebleeds in just one minute
Clonidine Topical Gel for Painful Diabetic Neuropathy to initiate Phase 2b study by year-end