Trials / Completed
CompletedNCT01335295
Safety Study of Flavocoxid in Duchenne Muscular Dystrophy
Open Pilot Trial to Test the Safety and Tolerability of Flavocoxid in Duchenne Muscular Dystrophy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Messina · Academic / Other
- Sex
- Male
- Age
- 4 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
Objective of this study is to evaluate safety and tolerability of flavocoxid administered at the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in association with steroids (deflazacort on alternate days) started at least one year before. The investigators will also perform a multidimensional clinical evaluation covering functional and muscle strength and quality of life (QoL)assessments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Flavocoxid | Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for 1 year |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2011-04-14
- Last updated
- 2014-02-03
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01335295. Inclusion in this directory is not an endorsement.