A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (MONA)
This study has been completed.
Horizon Pharma, Inc.
Information provided by (Responsible Party):
Horizon Pharma, Inc.
First received: May 26, 2008
Last updated: November 27, 2012
Last verified: November 2012
The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Horizon Pharma, Inc.:
Primary Outcome Measures:
- Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.
|Study Start Date:||June 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
After the 4 week run-in period with immediate release prednisone (Cortancyl), patients were switched to the identical dose of modified release prednisone tablets (Lodotra). Study medication for the Lodotra treatment period consisted of Lodotra in 2 dose strengths (5 mg and 1 mg prednisone per tablet). Patients were to take their tablets with or after the evening meal (at 10 pm +/- 30 minutes) for 4 weeks.
Administered with food at approximately 10 pm during the 4 week treatment period; patients received the identical dose of Lodotra as received of IR prednisone during the run-in period.
Other Name: modified release tablet formulation of prednisone
Active Comparator: Cortancyl
During the 4 week run-in period, patients remained on their respective pre-study dose of prednisone or equivalent. However, patients were standardized to 5 mg and 1 mg tablets of immediate release prednisone (Cortancyl). Patients were to take their tablets with or after the morning meal (at 8am +/- 30 minutes) for 4 weeks.
Administered in the morning with food during the 4 week run-in period; patients remained on their respective pre-study dose of prednisone or equivalent standardized to 5 mg and 1 mg tablets of immediate release (IR) prednisone (Cortancyl).
Other Name: immediate release prednisone tablets
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