Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

• Bowel Movement Timing and Frequency Rates [ Time Frame: Daily and weekly ] [ Designated as safety issue: No ]
• Frequency of Fecal Incontinence [ Time Frame: Daily and weekly ] [ Designated as safety issue: No ]
• Bowel Habit Assessments [ Time Frame: Daily and weekly ] [ Designated as safety issue: No ]
• Abdominal Assessments [ Time Frame: Weekly ] [ Designated as safety issue: No ]
• Treatment Effectiveness [ Time Frame: Weekly ] [ Designated as safety issue: No ]

• Bowel Movement Timing and Frequency Rates
• Frequency of Fecal Incontinence
• Bowel Habit Assessments
• Abdominal Assessments
• Treatment Effectiveness

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.

• Drug: Lubiprostone
  12 mcg capsule once daily (QD)
• Drug: Lubiprostone
  12 mcg capsule twice daily (BID)
• Drug: Lubiprostone
  24 mcg capsule twice daily (BID)
  Other Name: Amitiza®

• Experimental: 1
  Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
  Intervention: Drug: Lubiprostone
• Experimental: 2
  Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
  Intervention: Drug: Lubiprostone
• Experimental: 3
  Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
  Intervention: Drug: Lubiprostone

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
• Hirshsprung'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