Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00483184
Other study ID # 04HUBD01
Secondary ID
Status Completed
Phase Phase 2
First received June 5, 2007
Last updated April 27, 2009
Start date April 2006
Est. completion date April 2008

Study information

Verified date April 2009
Source Nobel Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 IFNa 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
Veldona,
Very low dose oral natural human interferon alpha lozenges

Locations

Country Name City State
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

Sponsors (2)

Lead Sponsor Collaborator
Nobel Pharmaceuticals Amarillo Biosciences, Inc.

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm. (0-12 weeks) No
Secondary Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety 12 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT03274648 - Dietary Interventions and Butyrate Production in Behçet's Patients N/A
Terminated NCT01693653 - Tocilizumab for the Treatment of Behcet's Syndrome Phase 2
Completed NCT04961463 - Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model N/A
Completed NCT05142995 - Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
Recruiting NCT00931957 - Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease N/A
Completed NCT03514056 - Frequency of Fibromyalgia in Behcet Disease
Not yet recruiting NCT03771768 - Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease N/A
Terminated NCT03554161 - Tocilizumab for the Treatment of Refractory Behcet's Uveitis Phase 2
Recruiting NCT04738864 - Neuro-ultrasound Assessment in Behcet's Disease N/A
Completed NCT03264391 - Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography
Completed NCT04386824 - Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
Completed NCT03962335 - Gut Microbiota and Behcet's Syndrome: a Dietary Intervention Trial (MAMBA Study) N/A
Completed NCT01532570 - Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions Phase 3
Not yet recruiting NCT04186559 - Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers Phase 2
Terminated NCT04218565 - Golimumab for the Treatment of Refractory Behcet's Uveitis Phase 2
Not yet recruiting NCT03747354 - Assessment of Disease Activity in Behcet by Complete Blood Count N/A
Recruiting NCT05200715 - AutoInflammatory Disease Alliance Registry (AIDA)
Completed NCT05098678 - Zinc Supplementation and Behçet's Syndrome N/A
Completed NCT00866359 - A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease Phase 2
Completed NCT05032248 - Uses of Tacrolimus in Behcet Disease N/A