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HARMONY - A Trial to Evaluate the Safety and Efficacy of Amitiza (Lubiprostone) in Children with Constipation

General Information

Age Group

Pediatrics

Status

Active

Protocol Number

N/A

Background Information

The goal of this study is to evaluate the safety and efficacy of Amitiza (lubiprostone) in children with constipation. Even though traditional treatment of functional constipation in children is available and safe, for many patients it does not provide a satisfying improvement, prompting interest in other therapeutic strategies. 

Since lubiprostone has been shown to increase the frequency of spontaneous bowel movements (SBMs) in both adults and children, further evaluation in well controlled studies in children is needed to demonstrate use in a paediatric population. Study requires use of an electronic diary nightly, 6 visits and 5 blood draws.

Eligibility Information

  • Children 6 to 18 years old with constipation