Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease

This study has been completed.
Sponsor:
Collaborator:
Amarillo Biosciences, Inc.
Information provided by:
Nobel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00483184
First received: June 5, 2007
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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
Behcet Syndrome
Behcet Disease
Mucocutaneous Ulceration
Biological: Veldona,
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nobel Pharmaceuticals:

Primary Outcome Measures:
  • Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm. [ Time Frame: (0-12 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: April 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
(placebo)0 IU IFNa
Biological: Veldona,
Very low dose oral natural human interferon alpha lozenges
Experimental: 2
(Veldona)500 IU IFNα bid
Biological: Veldona,
Very low dose oral natural human interferon alpha lozenges
Experimental: 3
(Veldona)1000 IU IFNα bid
Biological: Veldona,
Very low dose oral natural human interferon alpha lozenges

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is a male or a non-pregnant, non-lactating female.
  • Has a history and clinical presentation consistent with a diagnosis of Behçet's Disease and meets International Study Group criteria (Appendix B).
  • Has a history of oral ulcers for at least 12 months.
  • Has a history of monthly episodes of multiple oral ulcers.
  • Has the presence of at least 2 oral ulcers at study entry, both of which are accessible to measurement, with a total diameter of at least 4 mm.
  • Has signed an IRB approved subject consent form.
  • Has completed all screening procedures satisfactorily, is deemed to be an acceptable subject and is otherwise eligible for entry into the study.
  • Is willing and able to comply with the protocol.

Exclusion Criteria:

  • Has a severe, acute, or chronic systemic disease other than Behçet's Disease such as congestive heart failure, hepatic failure, renal failure, Systemic Lupus Erythematosus (SLE), Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS or ARC, or any other condition for which they are immunocompromised.
  • Is under active treatment for dental conditions, such that multiple dental office visits would be required during the study period, or presents with oral conditions which are not thought to be related to Behçet's Disease and, in the judgment of a qualified dentist, will require treatment during the study period.
  • Is suffering from any medical condition other than Behçet's Disease known to cause oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid, SLE, Crohn's disease, Reiter's syndrome, or AIDS.
  • Has an eating disorder and/or psychiatric illness requiring treatment.
  • Has hypersensitivity to interferon-alpha.
  • Is a pregnant or lactating female, or is of childbearing potential and is not using a medically acceptable contraceptive method throughout the study.
  • Has had previous exposure to any parenteral interferon therapy.
  • Has had exposure to IFNα lozenges within 30 days of screening.
  • Has had exposure to thalidomide within 30 days of screening.
  • Has had exposure to methotrexate within 30 days of screening.
  • Has had exposure to any immune-suppressive medication within 30 days of screening.
  • Has a history of, or is currently exhibiting, any disease or condition which, in the opinion of the Principal Investigator, would place the subject at increased risk during study therapy.
  • Has any abnormality in a hematological or biochemical variable which, in the opinion of the Principal Investigator, would place the subject at increased risk during study therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483184

Locations
Turkey
Gulhane Military Medical School
Ankara, Turkey
Osmangazi University Medical School, Dept of Rheumatology
Eskisehir, Turkey
Istanbul University Cerrahpasa Medical School Department of Internal Medicine
Istanbul, Turkey
Istanbul University Istanbul Medical School
Istanbul, Turkey
Sponsors and Collaborators
Nobel Pharmaceuticals
Amarillo Biosciences, Inc.
Investigators
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
  More Information

No publications provided by Nobel Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hasan Zeytin, Nobel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00483184     History of Changes
Other Study ID Numbers: 04HUBD01
Study First Received: June 5, 2007
Results First Received: April 27, 2009
Last Updated: April 27, 2009
Health Authority: Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Vasculitis
Interferons
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014