Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027391
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2001-12-05
Brief Title:
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy FSHD
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine whether albuterol or oxandrolone alone or in combination are able to increase strength and muscle mass in patients with FSHD It also will determine if albuterol given in pulsed fashion will have more effect than when given continuously
Detailed Description:
Patients will be randomized to 1 of 4 groups placebo pulsed albuterol oxandrolone or both pulsed albuterol and oxandrolone Treatment will continue for 52 weeks unless unacceptable side effects occur Patients will undergo testing of muscle function All patients will return for follow-up assessments at Weeks 4 12 26 and 52
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-002029-01 | None | None | None |