Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
NCT ID: NCT00452335
Last Updated: 2019-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
127 participants
INTERVENTIONAL
2007-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lubiprostone 12 mcg QD
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Lubiprostone
12 mcg capsule once daily (QD)
Lubiprostone 12 mcg BID
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Lubiprostone
12 mcg capsule twice daily (BID)
Lubiprostone 24 mcg BID
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Lubiprostone
24 mcg capsule twice daily (BID)
Interventions
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Lubiprostone
12 mcg capsule once daily (QD)
Lubiprostone
12 mcg capsule twice daily (BID)
Lubiprostone
24 mcg capsule twice daily (BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight of at least 12 kg and capable of swallowing a capsule
* Able to refrain from use of medications known to treat or associated with constipation symptoms
* Stable fiber therapy or ADHD therapy if using such medications
* Patient/Caregiver able to complete daily diary
* Patient able to use recommended rectal and/or oral rescue medications if needed
Exclusion Criteria
* Hirschsprung's Disease or Nonretentive Fecal Incontinence
* Untreated fecal impactions or impactions requiring digital manipulation
* Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
* Sexually active males and females must utilize acceptable birth control methods
* Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
2 Years
17 Years
ALL
No
Sponsors
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Sucampo Pharmaceuticals, Inc.
INDUSTRY
Sucampo Pharma Americas, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Hyman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
Children's Hospital and Research Center Oakland
Oakland, California, United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Center for Children's Digestive Health
Park Ridge, Illinois, United States
University of Illinois at Peoria
Peoria, Illinois, United States
University of Illinois at Chicago
Springfield, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Children's Hospital Boston
Boston, Massachusetts, United States
The Center for Human Nutrition, Inc.
Omaha, Nebraska, United States
AHS Hospital Corporation
Morristown, New Jersey, United States
Children's Research Institute
Columbus, Ohio, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
Southeastern Clinical Research
Chattanooga, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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0211SC-0641
Identifier Type: -
Identifier Source: org_study_id