Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004416
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Botulinum Toxin Type A for Achalasia
Sponsor:
University of Texas
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-04
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:
OBJECTIVES I Compare the efficacy of two doses of botulinum toxin in the treatment of achalasia
II Compare the safety of these two doses in these patients
II Compare the safety of these two doses in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind dose response study Patients are randomized to one of two treatment arms each arm receives a different dose of botulinum toxin type A
All patients undergo a flexible upper gastrointestinal endoscopy Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants Some patients may receive a second treatment depending on response andor time of relapse
Patients are followed daily for 7 days then every 1-6 months for 1-2 years after treatment
Completion date provided represents the completion date of the grant per OOPD records
All patients undergo a flexible upper gastrointestinal endoscopy Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants Some patients may receive a second treatment depending on response andor time of relapse
Patients are followed daily for 7 days then every 1-6 months for 1-2 years after treatment
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| UTMB-GCRC-470 | None | None | None |
| UTMB-FDR001421 | None | None | None |
| JHH-94122903 | None | None | None |
| MCMASTER-FDA | None | None | None |
| UTMB-97-230 | None | None | None |
| UTMB-BB | None | None | None |