Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
NCT ID: NCT01983306
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
292 participants
INTERVENTIONAL
2013-11-30
2015-04-30
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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SP-333 1 mg
1 mg SP-333 orally once daily for 4-week Treatment Period
SP-333 1 mg
Tablet
SP-333 3 mg
3 mg SP-333 orally once daily for 4-week Treatment Period
SP-333 3 mg
Tablet
SP-333 6 mg
6 mg SP-333 orally once daily for 4-week Treatment Period
SP-333 6 mg
Tablet
Placebo
Placebo orally once daily for 4-week Treatment Period
Placebo
Tablet
Interventions
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SP-333 1 mg
Tablet
SP-333 3 mg
Tablet
SP-333 6 mg
Tablet
Placebo
Tablet
Eligibility Criteria
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Inclusion Criteria
* Must have active OIC at screening
* Active OIC must be confirmed during baseline screening bowel habit and symptom diary
* Must be on stable diet
Exclusion Criteria
* Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)
* Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years
* Unstable thyroid disease
18 Years
75 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Renata Tenenbaum
Role: STUDY_DIRECTOR
Synergy Pharmaceuticals Inc.
Locations
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Synergy Research Site
Huntsville, Alabama, United States
Synergy Research Site
Mobile, Alabama, United States
Synergy Research Site
Phoenix, Arizona, United States
Synergy Research Site
Artesia, California, United States
Synergy Research Site
Laguna Hills, California, United States
Synergy Research Site
Oceanside, California, United States
Synergy Research Site
Sacramento, California, United States
Synergy Research Site
San Diego, California, United States
Synergy Research Site
San Diego, California, United States
Synergy Research Site
San Francisco, California, United States
Synergy Research Site
Hialeah, Florida, United States
Synergy Research Site
Miami, Florida, United States
Synergy Research Site
Miami Beach, Florida, United States
Synergy Research Site
Plant City, Florida, United States
Synergy Research Site
Plantation, Florida, United States
Synergy Research Site
Port Orange, Florida, United States
Synergy Research Site
Sarasota, Florida, United States
Synergy Research Site
West Palm Beach, Florida, United States
Synergy Research Site
Winter Haven, Florida, United States
Synergy Research Site
Atlanta, Georgia, United States
Synergy Research Site
Bloomington, Illinois, United States
Synergy Research Site
Traverse City, Michigan, United States
Synergy Research Site
St Louis, Missouri, United States
Synergy Research Site
Las Vegas, Nevada, United States
Synergy Research Site
Great Neck, New York, United States
Synergy Research Site
New York, New York, United States
Synergy Research Site
Concord, North Carolina, United States
Synergy Research Site
Greensboro, North Carolina, United States
Synergy Research Site
Salisbury, North Carolina, United States
Synergy Research Site
Winston-Salem, North Carolina, United States
Synergy Research Site
Dayton, Ohio, United States
Synergy Research Site
Oklahoma City, Oklahoma, United States
Synergy Research Site
Oklahoma City, Oklahoma, United States
Synergy Research Site
Oklahoma City, Oklahoma, United States
Synergy Research Site
Medford, Oregon, United States
Synergy Research Site
Orangeburg, South Carolina, United States
Synergy Research Site
Chattanooga, Tennessee, United States
Synergy Research Site
Arlington, Texas, United States
Synergy Research Site
Dallas, Texas, United States
Synergy Research Site
Dallas, Texas, United States
Synergy Research Site
Houston, Texas, United States
Synergy Research Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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SP333201-01
Identifier Type: -
Identifier Source: org_study_id
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