Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
NCT ID: NCT00547898
Last Updated: 2020-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
374 participants
INTERVENTIONAL
2007-10-31
2011-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Crofelemer 125 mg
Crofelemer 125 mg
Crofelemer 125 mg
Crofelemer 250 mg
Crofelemer 250 mg
Crofelemer 250 mg
Crofelemer 500 mg
Crofelemer 500 mg
Crofelemer 500 mg
Interventions
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Crofelemer 125 mg
Crofelemer 125 mg
Crofelemer 250 mg
Crofelemer 250 mg
Crofelemer 500 mg
Crofelemer 500 mg
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening
* Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration
* Colonoscopy within the past 5 years if ≥ 50 years of age.
Exclusion Criteria
* Current or past gastrointestinal (GI) medical or surgical conditions
* Use of certain opiate pain medication within 2 weeks of screening
* Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition
* CD4 counts \< 100 cells/mm3
* Previous randomization into this study, or into any other crofelemer study
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Ponce, , Puerto Rico
Rio Piedras, , Puerto Rico
San Juan, , Puerto Rico
Houston, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Lynchburg, Virginia, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Beverly Hills, California, United States
Fountain Valley, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Oakland, California, United States
Palm Springs, California, United States
San Diego, California, United States
San Francisco, California, United States
San Mateo, California, United States
Denver, Colorado, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Wilton Manors, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
Great Neck, New York, United States
Manhasset, New York, United States
Mount Vernon, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Gastonia, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Columbia, South Carolina, United States
Austin, Texas, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Countries
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Other Identifiers
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NP303-101
Identifier Type: -
Identifier Source: org_study_id
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