Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation

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.

Inclusion Criteria:

• 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 Criteria:

• 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