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

Tracking Information
First Submitted Date ICMJE	November 2, 1999
First Posted Date ICMJE	August 31, 2001
Last Update Posted Date	June 24, 2005
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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 ICMJE	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	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	Diarrhea; HIV Infections
Intervention ICMJE	Drug: Octreotide
Study Arms	Not Provided
Publications *	Romeu J, Miro JM, Mallolas J, Sirera G, Tortosa F, Clotet B. Sandostatin (SMS-201-995) in the long-term management of chronic diarrhea in AIDS patients. Int Conf AIDS. 1991 Jun 16-21;7(2):272 (abstract no WB2362)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria Patients must have the following: Uncontrolled diarrhea that is either a manifestation or complication of documented HIV infection.; Ability to communicate, participate, and comply with the requirements of the study.; Capability of self administering injections of study medication or have responsible family member or companion who can.; Given written consent prior to study entry. Prior Medication: Required: At least two weeks of conventional dosing regimens of antidiarrheal medication (e.g.:; Lomotil, Imodium, Paregoric) within one month prior to study entry. OR Patients with evidence of upper or lower GI infection(s) for which there is approved, potentially curative therapy must have failed appropriate treatment for at least two weeks. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Evidence of underlying immunosuppressive disease other than due to HIV.; Diarrhea caused by a known gastrointestinal disorder such as idiopathic ulcerative colitis, Crohn's disease, acute stool culture positive bacterial colitis (documented within the last 2 weeks prior to study entry AND not having at least 2 weeks of antibiotic therapy), pseudomembranous colitis (Clostridium difficile toxin positive), short gut syndrome, chronic pancreatitis (alcoholic or idiopathic), ischemic bowel disease, or enteroenteric fistulae. Patients with the following are excluded: Diarrhea that can be controlled with conventional antidiarrheal agents.; Stool weight at either of the 2 baseline periods that average < 500 g/day.; Evidence of underlying immunosuppressive disease other than due to HIV.; Diarrhea caused by other gastrointestinal disorders not related to HIV. Prior Medication: Excluded: Previously treated with Sandostatin as an anti-diarrheal agent.; Experimental antidiarrheal drugs within one month of study entry. Present intravenous drug abuse.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00002252
Other Study ID Numbers ICMJE	102A; D203
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Sandoz
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	NIH AIDS Clinical Trials Information Service
Verification Date	August 1992
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP