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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their 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 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > 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



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

For Condition: Diarrhea,HIV Infections
Status: Completed
Sponsor(s): Sandoz Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 

Location and Contact Information:

Emory Univ School of Medicine
Atlanta,  Georgia,  30303
United States
 

Univ of Wisconsin School of Medicine
Madison,  Wisconsin,  53792
United States
 

Maine Med Ctr Med Clinics
Portland,  Maine,  04102
United States
 

Buckley Braffman Stern Med Associates
Philadelphia,  Pennsylvania,  19107
United States
 

Einstein Med School
Bronx,  New York,  10461
United States
 

Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence,  Rhode Island,  02906
United States
 

Univ of Missouri at Kansas City School of Medicine
Kansas City,  Missouri,  64108
United States
 

UCSD Med Ctr
San Diego,  California,  92103
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland,  Oregon,  97210
United States
 

Med Service
Miami,  Florida,  33125
United States
 

Univ TX Galveston Med Branch
Galveston,  Texas,  77550
United States
 

Infectious Disease Physicians Inc
Annandale,  Virginia,  22203
United States
 

SUNY Stony Brook / Health Sciences Ctr
Stony Brook,  New York,  117948121
United States
 

Douglas Plesko
Boston,  Massachusetts,  02115
United States
 

USC School of Medicine
Los Angeles,  California,  90033
United States
 

Baylor College of Medicine
Houston,  Texas,  77030
United States
 

San Mateo County Gen Hosp
San Mateo,  California,  94403
United States
 

Kaiser Permanente Med Ctr
San Francisco,  California,  94115
United States
 

UCSF - San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

Boston City Hosp
Boston,  Massachusetts,  02118
United States
 

Henry Ford Hosp
Detroit,  Michigan,  48202
United States
 


Additional Information:
Study ID Numbers:
  102A;  D203
Study Start Date: 
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002252

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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

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