drugset / Trial / NCT00721331

A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

NCT00721331

Phase 1 Completed 20 enrolled Zalicus
RandomizedFactorialTriple-blindTreatment

Summary

This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.

Timeline

Start
2008-07
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Loratadine Small molecule 0.1 % Topical
Subject Loratadine Small molecule 0.3 % Topical
Comparator Mometasone Other / unclassified 0.1 % Topical
Subject Nortriptyline Small molecule 0.1 % Topical

Indications