Back to resultsA 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.
Primary Purpose
Diarrhea, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Octreotide
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Octreotide, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Eligibility Criteria
Inclusion Criteria Patients must have the following: Only patients who have completed the duration of Study D203, FDA 102A will be eligible for this study. Each of these patients must give written informed consent to participate in Study D204, FDA 102B as well.
Sites / Locations
- USC School of Medicine
- UCSD Med Ctr
- UCSF - San Francisco Gen Hosp
- Kaiser Permanente Med Ctr
- San Mateo County Gen Hosp
- Med Service
- Emory Univ School of Medicine
- Rush Presbyterian - Saint Luke's Med Ctr
- Maine Med Ctr Med Clinics
- Douglas Plesko
- Boston City Hosp
- Henry Ford Hosp
- Univ of Missouri at Kansas City School of Medicine
- Mount Sinai Med Ctr
- SUNY Stony Brook / Health Sciences Ctr
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Buckley Braffman Stern Med Associates
- Miriam Hosp / Family Healthcare Ctr at SSTAR
- Univ TX Galveston Med Branch
- Baylor College of Medicine
- Infectious Disease Physicians Inc
- Univ of Wisconsin School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002253
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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 1992
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, HIV Infections
Keywords
Octreotide, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Octreotide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have the following:
Only patients who have completed the duration of Study D203, FDA 102A will be eligible for this study.
Each of these patients must give written informed consent to participate in Study D204, FDA 102B as well.
Facility Information:
Facility Name
USC School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSD Med Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Mateo County Gen Hosp
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Name
Med Service
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Maine Med Ctr Med Clinics
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Douglas Plesko
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston City Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Univ of Missouri at Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Stony Brook / Health Sciences Ctr
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948121
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Miriam Hosp / Family Healthcare Ctr at SSTAR
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Univ of Wisconsin School of Medicine
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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.
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