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Sponsored by: |
CombinatoRx |
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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
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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 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
CombinatoRx Atopic Dermatitis |
Topical CRx-197 Normal Healthy Volunteers |
Anti-Inflammatory Agents Neurotransmitter Agents Dermatitis, Atopic Skin Diseases Adrenergic Agents Mometasone furoate Psychotropic Drugs Anti-Allergic Agents Healthy Histamine Antidepressive Agents, Tricyclic Hypersensitivity |
Histamine Antagonists Genetic Diseases, Inborn Loratadine Nortriptyline Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists Antipruritics Skin Diseases, Eczematous Skin Diseases, Genetic Antidepressive Agents Dermatitis |
Anti-Inflammatory Agents Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Dermatitis, Atopic Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Hypersensitivity Loratadine Therapeutic Uses Nortriptyline Skin Diseases, Eczematous Antipruritics |
Dermatologic Agents Skin Diseases, Genetic Antidepressive Agents Dermatitis Immune System Diseases Skin Diseases Mometasone furoate Histamine Agents Anti-Allergic Agents Pharmacologic Actions Antidepressive Agents, Tricyclic Histamine Antagonists Genetic Diseases, Inborn Hypersensitivity, Immediate Histamine H1 Antagonists |