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.
NCT ID: NCT00002253
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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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
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Octreotide
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Locations
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USC School of Medicine
Los Angeles, California, United States
UCSD Med Ctr
San Diego, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
San Mateo County Gen Hosp
San Mateo, California, United States
Med Service
Miami, Florida, United States
Emory Univ School of Medicine
Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Maine Med Ctr Med Clinics
Portland, Maine, United States
Douglas Plesko
Boston, Massachusetts, United States
Boston City Hosp
Boston, Massachusetts, United States
Henry Ford Hosp
Detroit, Michigan, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States
Mount Sinai Med Ctr
New York, New York, United States
SUNY Stony Brook / Health Sciences Ctr
Stony Brook, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States
Countries
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Other Identifiers
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D204
Identifier Type: -
Identifier Source: secondary_id
102B
Identifier Type: -
Identifier Source: org_study_id