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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.

Not Applicable
Completed
Conditions
Diarrhea
HIV Infections
Registration Number
NCT00002253
Lead Sponsor
Sandoz
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (22)

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

Scroll for more (12 remaining)
USC School of Medicine
🇺🇸Los Angeles, California, United States

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