Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002252
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1992

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002252 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Diarrhea
  • HIV Infections
Drug: Octreotide
Not Provided
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.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002252
102A, D203
Not Provided
Not Provided
Sandoz Inc.
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
August 1992

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP