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.
Completed · Not applicable
Conditions studied: Diarrhea, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002253
- Run by
- Sandoz
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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