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.
2 other identifiers
interventional
N/A
1 country
22
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.
Trial Health
Trial Health Score
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22 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (22)
USC School of Medicine
Los Angeles, California, 90033, United States
UCSD Med Ctr
San Diego, California, 92103, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
San Mateo County Gen Hosp
San Mateo, California, 94403, United States
Med Service
Miami, Florida, 33125, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Maine Med Ctr Med Clinics
Portland, Maine, 04102, United States
Douglas Plesko
Boston, Massachusetts, 02115, United States
Boston City Hosp
Boston, Massachusetts, 02118, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
SUNY Stony Brook / Health Sciences Ctr
Stony Brook, New York, 117948121, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, 02906, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1992-08