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

NCT00721331 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

nortriptyline HCl + loratadine

Topical

DRUG

nortriptyline HCl + loratadine

Topical

DRUG

nortriptyline HCl

Topical

DRUG

mometasone furoate

Topical

DRUG

Active ingredient free vehicle cream of CRx-197

Topical

Sponsors & Collaborators

  • Zalicus

    lead INDUSTRY

Principal Investigators

  • Jutta Harten, MD · Proinnovera GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00721331 on ClinicalTrials.gov