Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo Pharma Americas, LLC; Sucampo Pharmaceuticals, Inc.
• Collaborators: Sucampo Pharmaceuticals, Inc.; Takeda
• Treatments: Lubiprostone

Criteria

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