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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.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002253
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, HIV Infections

Keywords

Octreotide, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

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.

Interventions

DRUGOctreotide

Sponsors

Sandoz
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026