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Sponsors and Collaborators: |
Nobel Pharmaceuticals Amarillo Biosciences, Inc. |
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Information provided by: | Nobel Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00483184 |
The purpose of this study is to determine the safety and efficacy of natural human interferon alpha (IFN alpha) on size, number, incidence and pain of oral ulcers associated with Behçet's Disease (BD).
Condition | Intervention | Phase |
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Behcet Syndrome Behcet Disease Mucocutaneous Ulceration |
Biological: Veldona, |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study, Evaluation of Low Dose Natural Human Interferon Alpha Administered by the Oral Mucosal Route in the Treatment of Behçet's Disease |
Estimated Enrollment: | 90 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
0 IU IFN alpha (placebo) bid (n=30)
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Biological: Veldona,
Very low dose oral natural human interferon alpha lozenges
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2: Experimental
500 IU IFNα bid (n=30)
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Biological: Veldona,
Very low dose oral natural human interferon alpha lozenges
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3: Experimental
1000 IU IFNα bid (n=30)
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Biological: Veldona,
Very low dose oral natural human interferon alpha lozenges
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Behçet's disease is a severe chronic relapsing inflammatory disorder marked by oral and genital ulcers, uveitis and skin lesions, as well as varying multisystem involvement including the joints, blood vessels, central nervous system, and gastrointestinal tract. Oral ulcers are the initial symptom for most of Behçet's cases and are the single manifestation of the disease required for an official diagnosis, along with two other hallmark symptoms.
Ninety (90) patients will be enrolled in a randomized, parallel, double-blind, placebo-controlled study to evaluate the effectiveness of low dose natural human IFN α administered by the oral mucosal route in reducing the number, size, incidence and pain of oral ulcers in patients with Behçet's disease.
The clinical trial will consist of 3 groups of patients randomized in a 1:1:1 ratio to twice daily receive 2 lozenges containing 500 IU IFN α(2,000 IU daily, n=30), one active (500 IU) and one placebo lozenge (1,000 IU daily, n=30) or 2 placebo lozenges (n=30). Subjects will be monitored weekly over an initial 4 weeks of treatment and then bi-weekly over an additional 8 weeks of treatment. Medication will be self-administered as 2 lozenges taken twice daily (morning and evening). Oral lesions will be counted and measured at each study visit, and patients will answer a series of questionnaires. Results will be subjected to statistical analysis at the completion of the study, with change in total ulcer burden of a patient, a measurement of the total oral mucosal surface area involved with ulcerous lesions at each visit, serving as the primary endpoint. The total ulcer burden from each treated visit will be compared to the baseline total ulcer burden and the amount of change determined. Patients with a 75% decrease in total ulcer burden will be considered responders.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Turkey | |
Istanbul University Cerrahpasa Medical School Department of Internal Medicine | |
Istanbul, Turkey | |
Osmangazi University Medical School, Dept of Rheumatology | |
Eskisehir, Turkey | |
Gulhane Military Medical School | |
Ankara, Turkey | |
Istanbul University Istanbul Medical School | |
Istanbul, Turkey |
Study Director: | Hasan Yazici, MD | Istanbul University Cerrahpaşa Medical School |
Principal Investigator: | Cem Mat, MD | Istanbul University Cerrahpasa Medical School |
Principal Investigator: | Cengiz Korkmaz, MD | Osmangazi University Medical School |
Principal Investigator: | Ayhan Dinc, MD | Gülhane Military Medical School |
Principal Investigator: | Ahmet Gul, MD | İstanbul University Istanbul Medical School |
Responsible Party: | Nobel Pharmaceuticals ( Hasan Zeytin ) |
Study ID Numbers: | 04HUBD01 |
Study First Received: | June 5, 2007 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00483184 |
Health Authority: | Turkey: Ministry of Health; United States: Food and Drug Administration |
Interferon-alpha Mouth Diseases Uveitis, Anterior Panuveitis Oral Ulcer Vasculitis Skin Diseases Ulcer |
Eye Diseases Interferons Vascular Diseases Behcet Syndrome Uveitis Stomatognathic Diseases Interferon Alfa-2a Behcet syndrome |
Anti-Infective Agents Uveal Diseases Skin Diseases, Vascular Disease Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents |