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.

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Sandoz Inc.
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002253

Purpose

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.

Condition	Intervention
Diarrhea HIV Infections	Drug: Octreotide

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: AIDS Diarrhea

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002253

Show 22 Study Locations

Sponsors and Collaborators

Sandoz Inc.

More Information

No publications provided

Study ID Numbers:	102B, D204
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002253 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Octreotide
Diarrhea
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Diarrhea
Slow Virus Diseases
Antineoplastic Agents, Hormonal
Signs and Symptoms, Digestive
Immune System Diseases
Antineoplastic Agents
Acquired Immunodeficiency Syndrome
Gastrointestinal Agents
Octreotide

Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Signs and Symptoms
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009