Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002253
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin SMS 201-995 in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either Responders or Non-Responders in a Prior Placebo-Controlled Double-Blind Sandostatin Study
Sponsor:
Sandoz
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin SMS 201-995 in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either Responders or Non-Responders in a Prior Placebo-Controlled Double-Blind Sandostatin Study
Status:
COMPLETED
Status Verified Date:
1992-08
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:
The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be Responders in a previous placebo-controlled double-blind study of Sandostatin Study D203 - FDA 102A
The secondary objectives include 1 To evaluate clinical efficacy and safety of open-label Sandostatin in patients who were Non-Responders in Study D203 - FDA 102A 2 To evaluate the efficacy and safety of Sandostatin during prolonged open-label treatment in Responders from Study D03 - FDA 102A
The secondary objectives include 1 To evaluate clinical efficacy and safety of open-label Sandostatin in patients who were Non-Responders in Study D203 - FDA 102A 2 To evaluate the efficacy and safety of Sandostatin during prolonged open-label treatment in Responders from Study D03 - FDA 102A
Detailed Description:
None
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 |
|---|---|---|---|
| D204 | None | None | None |