Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

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