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

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ClinicalTrials.gov Identifier: NCT00483184
Recruitment Status : Completed
First Posted : June 6, 2007
Results First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Sponsor:
Collaborator:
Amarillo Biosciences, Inc.
Information provided by:
Nobel Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Behcet Syndrome
Behcet Disease
Mucocutaneous Ulceration
Intervention Biological: Veldona,
Enrollment 84
Recruitment Details Eighty four Behcet's Disease patients were followed at the rheumatology or dedicated BS outpatient clinics of 4 medical schools in Turkey.
Pre-assignment Details Consecutive patients aged 18-75 fulfilling Behçet’s disease International Study Group criteria (16) with the presence of active oral ulcers (OU) within the previous year were included. A further requirement was the presence of at least 2 OU accessible to measurement and with a total diameter of at least 4 mm.
Arm/Group Title 1 2 3
Hide Arm/Group Description (placebo)0 IU IFN alpha (Veldona)500 IU IFNα bid (Veldona)1000 IU IFNα bid
Period Title: Overall Study
Started 27 31 26
Completed 22 27 23
Not Completed 5 4 3
Reason Not Completed
Withdrawal by Subject             2             2             0
Lost to Follow-up             1             0             0
Adverse Event             1             2             2
Protocol Violation             1             0             1
Arm/Group Title 1 2 3 Total
Hide Arm/Group Description (placebo)0 IU IFN alpha (Veldona)500 IU IFNα bid (Veldona)1000 IU IFNα bid Total of all reporting groups
Overall Number of Baseline Participants 27 31 26 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 31 participants 26 participants 84 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
31
 100.0%
26
 100.0%
84
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 31 participants 26 participants 84 participants
36  (8.6) 37  (10.2) 36  (9.4) 37  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 31 participants 26 participants 84 participants
Female
20
  74.1%
20
  64.5%
19
  73.1%
59
  70.2%
Male
7
  25.9%
11
  35.5%
7
  26.9%
25
  29.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Turkey Number Analyzed 27 participants 31 participants 26 participants 84 participants
27 31 26 84
1.Primary Outcome
Title Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.
Hide Description A patient with a 75% or greater decrease in total OU for three visits was considered a “sustained responder”.
Time Frame (0-12 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 2 3
Hide Arm/Group Description:
(placebo)0 IU IFN alpha
(Veldona)500 IU IFNα bid
(Veldona)1000 IU IFNα bid
Overall Number of Participants Analyzed 22 27 23
Measure Type: Number
Unit of Measure: patients with sustained response
13 10 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1, 2, 3
Comments Results were expressed as mean or number. Normal distributed data among the treatment groups were compared by One-way ANOVA test, non-normal distributed data were compared by Kruskal Wallis test, and then Bonferroni post-hoc test was used for multiple comparisons. Differences from baseline within treatment groups were evaluated by repeated measures ANOVA test for normal distributed data, Freidman test for non-normal distributed data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 2 3
Hide Arm/Group Description (placebo)0 IU IFN alpha (Veldona)500 IU IFNα bid (Veldona)1000 IU IFNα bid
All-Cause Mortality
1 2 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1 2 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      1      0    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
cervical intraepithelial neoplasia *  0/0  0 1/1 (100.00%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 2 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2      5      2    
Gastrointestinal disorders       
nausea *  0/0  0 2/2 (100.00%)  2 0/0  0
General disorders       
headache *  2/2 (100.00%)  2 4/4 (100.00%)  6 2/2 (100.00%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Hasan Zeytin MD., Ph.D.
Organization: Nobel Ilac San ve Tic. A.S.
Phone: +90 216 6336012 ext 6012
Responsible Party: Hasan Zeytin, Nobel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00483184     History of Changes
Other Study ID Numbers: 04HUBD01
First Submitted: June 5, 2007
First Posted: June 6, 2007
Results First Submitted: April 27, 2009
Results First Posted: June 16, 2009
Last Update Posted: June 16, 2009