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| Descriptive Information Fields | |
| Brief Title † | A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea |
| Official Title † | A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea |
| Brief Summary | To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes. |
| Detailed Description | |
| Study Phase | |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Diarrhea HIV Infections |
| Intervention † | Drug: Octreotide |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Patients must have the following:
Prior Medication: Required:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
Present intravenous drug abuse. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002252 |
| Organization ID | 102A |
| Secondary IDs †† | D203 |
| Study Sponsor † | Sandoz Pharmaceuticals |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | August 1992 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |