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Sponsored by: |
CombinatoRx |
---|---|
Information provided by: | CombinatoRx |
ClinicalTrials.gov Identifier: | NCT00721331 |
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.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Drug: nortriptyline HCl + loratadine Drug: nortriptyline HCl Drug: mometasone furoate Drug: Active ingredient free vehicle cream of CRx-197 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Factorial Assignment, Safety Study |
Official Title: | A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine): Experimental |
Drug: nortriptyline HCl + loratadine
Topical
|
CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine): Experimental |
Drug: nortriptyline HCl + loratadine
Topical
|
0.1% nortriptyline HCl: Experimental |
Drug: nortriptyline HCl
Topical
|
0.1% mometasone furoate: Active Comparator |
Drug: mometasone furoate
Topical
|
Active ingredient free vehicle cream of CRx-197: Placebo Comparator |
Drug: Active ingredient free vehicle cream of CRx-197
Topical
|
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CombinatoRx, Inc. ( James Keane, Sr. Clinical Project Manager ) |
Study ID Numbers: | CRx-197-001, EudraCT # 2008-000611-15 |
Study First Received: | July 21, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00721331 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
CombinatoRx Atopic Dermatitis |
Topical CRx-197 Normal Healthy Volunteers |
Dermatitis, Atopic Skin Diseases Mometasone furoate Healthy Histamine Hypersensitivity Genetic Diseases, Inborn |
Loratadine Nortriptyline Hypersensitivity, Immediate Histamine phosphate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Immune System Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Histamine Agents Anti-Allergic Agents |
Pharmacologic Actions Antidepressive Agents, Tricyclic Histamine Antagonists Therapeutic Uses Histamine H1 Antagonists Antipruritics Histamine H1 Antagonists, Non-Sedating Dermatologic Agents Central Nervous System Agents Antidepressive Agents |