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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.

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ClinicalTrials.gov Identifier: NCT00002253
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Diarrhea HIV Infections Drug: Octreotide

Study Design

Study Type : Interventional  (Clinical Trial)
Masking: Double
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 the National Library of Medicine

MedlinePlus related topics: Diarrhea HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002253


  Hide Study Locations
Locations
United States, California
USC School of Medicine
Los Angeles, California, United States, 90033
UCSD Med Ctr
San Diego, California, United States, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
San Mateo County Gen Hosp
San Mateo, California, United States, 94403
United States, Florida
Med Service
Miami, Florida, United States, 33125
United States, Georgia
Emory Univ School of Medicine
Atlanta, Georgia, United States, 30303
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Maine
Maine Med Ctr Med Clinics
Portland, Maine, United States, 04102
United States, Massachusetts
Douglas Plesko
Boston, Massachusetts, United States, 02115
Boston City Hosp
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
SUNY Stony Brook / Health Sciences Ctr
Stony Brook, New York, United States, 117948121
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, United States, 02906
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
United States, Wisconsin
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Sandoz
More Information

ClinicalTrials.gov Identifier: NCT00002253     History of Changes
Other Study ID Numbers: 102B
D204
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 1992

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