IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a 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.
This study has been completed.
Sponsor:
Sandoz
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | 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 NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| 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
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
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 |
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 21, 2017