Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

Completed · Phase 4

Conditions studied: Constipation

In brief

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 patients.

Key facts

Study ID

NCT00452335

Run by

Sucampo Pharma Americas, LLC

People needed

127

Starts

2007-01-01

Expected to finish

2008-10-01

Last updated by the study team

2019-12-17

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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