Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004685
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy
Sponsor:
Ohio State University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
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:
OBJECTIVES I Determine whether albuterol increases strength in patients with facioscapulohumeral dystrophy as measured by quantitative voluntary isometric contraction testing
II Determine whether albuterol increases muscle mass in this patient population as determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry DEXA
III Examine the long term safety of albuterol in this patient population
II Determine whether albuterol increases muscle mass in this patient population as determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry DEXA
III Examine the long term safety of albuterol in this patient population
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled study Patients are randomized into one of three treatment groups The first group receives placebo The second group receives low dose albuterol orally every 12 hours The third group receives high dose albuterol orally every 12 hours Treatment continues for 52 weeks unless unacceptable side effects occur
All patients return for follow up assessments at weeks 4 12 24 and 52
Completion date provided represents the completion date of the grant per OOPD records
All patients return for follow up assessments at weeks 4 12 24 and 52
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OSURF-96H0022 | None | None | None |
| OSURF-FDR001293 | None | None | None |