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 |
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Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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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 | Phase |
|---|---|---|
| Diarrhea HIV Infections | Drug: Octreotide | Not Applicable |
| 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. |
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
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| 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:
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Octreotide Diarrhea Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
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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 |