Status:
COMPLETED
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Lead Sponsor:
Sucampo Pharma Americas, LLC
Collaborating Sponsors:
Sucampo Pharmaceuticals, Inc.
Conditions:
Constipation
Eligibility:
All Genders
2-17 years
Phase:
PHASE4
Brief Summary
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of pat...
Eligibility Criteria
Inclusion
- Less than 18 years of age
- 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
- Constipation is associated with some medical, anatomic, physical, organic, or other condition
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00452335
Start Date
January 1 2007
End Date
October 1 2008
Last Update
December 17 2019
Active Locations (19)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72005
3
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
4
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207