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.

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Sandoz

Status

Completed

Conditions

Diarrhea
HIV Infections

Treatments

Drug: Octreotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002253
D204
102B

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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