Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483184
Status:
COMPLETED
Last Update Posted:
2009-06-16
First Post:
2007-06-05
Brief Title:
Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcets Disease
Sponsor:
Nobel Pharmaceuticals
Organization:
Nobel Pharmaceuticals
Study Overview
Official Title:
Phase II Study Evaluation of Low Dose Natural Human Interferon Alpha Administered by the Oral Mucosal Route in the Treatment of Behçets Disease
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Behçets Disease BD
Detailed Description:
Behçets 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 Behçets 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 Behçets disease
The clinical trial will consist of 3 groups of patients randomized in a 111 ratio to twice daily receive 2 lozenges containing 500 IU IFN α2000 IU daily n30 one active 500 IU and one placebo lozenge 1000 IU daily n30 or 2 placebo lozenges n30 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
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 Behçets disease
The clinical trial will consist of 3 groups of patients randomized in a 111 ratio to twice daily receive 2 lozenges containing 500 IU IFN α2000 IU daily n30 one active 500 IU and one placebo lozenge 1000 IU daily n30 or 2 placebo lozenges n30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None