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.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002253

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: August 1992

History of Changes

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:	Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment
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: Diarrhea HIV/AIDS

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 22 Study Locations

Sponsors and Collaborators

Sandoz

More Information


ClinicalTrials.gov Identifier:	NCT00002253 History of Changes
Other Study ID Numbers:	102B D204
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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:


HIV Infections Immunologic Deficiency Syndromes Diarrhea Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms Octreotide Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents

ClinicalTrials.gov processed this record on September 27, 2016

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