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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,

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
1 (placebo)0 IU IFN alpha
2 (Veldona)500 IU IFNα bid
3 (Veldona)1000 IU IFNα bid

Participant Flow:   Overall Study
    1   2   3
STARTED   27   31   26 
COMPLETED   22   27   23 
NOT COMPLETED   5   4   3 
Withdrawal by Subject                2                2                0 
Lost to Follow-up                1                0                0 
Adverse Event                1                2                2 
Protocol Violation                1                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 (placebo)0 IU IFN alpha
2 (Veldona)500 IU IFNα bid
3 (Veldona)1000 IU IFNα bid
Total Total of all reporting groups

Baseline Measures
   1   2   3   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   31   26   84 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   27   31   26   84 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (8.6)   37  (10.2)   36  (9.4)   37  (9.4) 
Gender 
[Units: Participants]
       
Female   20   20   19   59 
Male   7   11   7   25 
Region of Enrollment 
[Units: Participants]
       
Turkey   27   31   26   84 


  Outcome Measures

1.  Primary:   Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.   [ Time Frame: (0-12 weeks) ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: hasan.zeytin@nobel.com.tr


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
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