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Sponsored by: |
Jacobus Pharmaceutical |
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Information provided by: | Jacobus Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00429533 |
The purpose of this 12-month study was to determine the efficacy of dapsone as a glucocorticoid-sparing agent in maintenance phase pemphigus vulgaris.
Condition | Intervention | Phase |
---|---|---|
Pemphigus Vulgaris |
Drug: Dapsone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Prospective Randomized Placebo-Controlled Clinical Trial of Dapsone as a Glucocorticoid-Sparing Agent in Maintenance Phase Pemphigus Vulgaris |
Estimated Enrollment: | 48 |
Study Start Date: | November 1996 |
Estimated Study Completion Date: | February 2004 |
Patients were entered into the trial on steroids in combination with cytotoxic agents as needed. The steroid dose was the lowest dose at which the patient’s disease was controlled before the last flare (see eligibility criteria). The patients were randomized to receive either Dapsone or placebo.
Treatment was to be started at a dose of 50 mg and increased by 25 mg increments each week once the hemoglobin was shown not to have dropped by more than 2 gm/dl. The target dose was 150 mg and patients who did not respond could be advanced to 200 mg daily. After beginning treatment, a standardized steroid taper was commenced. A standardized steroid taper was suggested with tapering by 10 mg/wk for doses above 40 mg/day or more slowly if warranted. A slower taper thereafter or an every other day dosing schedule would be elected according to the individual investigator’s preference.
Flares were treated by increasing the dose of steroids - in the case of a mild flare to the last dose preceding the flare, in the case of a moderate flare by 20 mg/day and in the case of a severe flare by 40 mg/day. Tapering was to be resumed once the disease had stabilized. Disease activity was assessed by a simple scoring system for skin, mucosa, and sites involved. Laboratory assessments initially weekly became monthly once the study medication dosage was stabilized.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Northwestern University Medical Center | |
Chicago, Illinois, United States, 60611-3010 | |
Rush-Presbyterian-St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, New Jersey | |
Cooper Hospital/University Medical Center | |
Camden, New Jersey, United States, 08103 | |
United States, New York | |
The New York VA Medical Center, New York University | |
New York, New York, United States, 10010 | |
United States, Ohio | |
Case Western Reserve University School of Medicine | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
University of Texas | |
Dallas, Texas, United States, 75235 |
Study Chair: | Victoria P. Werth, MD | University of Pennsylvania |
Principal Investigator: | Victoria P. Werth, MD | University of Pennsylvania |
Principal Investigator: | Diana Chen, MD | Northwestern University |
Principal Investigator: | Warren R Heymann, MD | Cooper Hospital/University Medical Center |
Principal Investigator: | Neil Korman, MD | Case Western Reserve University School of Medicine |
Principal Investigator: | Amit Pandya, MD | University of Texas |
Principal Investigator: | M J Rico, MD | The New York VA Medical Center - New York University |
Principal Investigator: | Michael D Tharp, MD | Rush University Medical Center |
Study ID Numbers: | 51,988 |
Study First Received: | January 29, 2007 |
Last Updated: | February 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00429533 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Folic Acid Anti-Bacterial Agents Antimalarials Pemphigus Vulgaris Autoimmune Diseases Skin Diseases, Vesiculobullous |
Skin Diseases Dapsone Folic Acid Antagonists Glucocorticoids Pemphigus |
Anti-Infective Agents Antiprotozoal Agents Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Skin Diseases, Vesiculobullous Skin Diseases Immune System Diseases Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Pemphigus Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Dapsone Leprostatic Agents |