Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

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