Lubiprostone for Children With Constipation

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is for children with constipation.

Children who completed 3 months of treatment in the earlier study (NCT02042183):

• were invited to participate

• will receive lubiprostone for 9 more months

• will see if lubiprostone safely relieves their constipation if taken for a whole year

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo AG; Sucampo Pharma Americas, LLC
• Collaborators: Sucampo Pharma Americas, LLC; Takeda
• Treatments: Lubiprostone

Criteria

Inclusion Criteria:

• Has completed the 3-month placebo-controlled study (NCT02042183)

• Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility

Exclusion Criteria:

• Has untreated faecal impaction at the time of rolling over into study

• Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease

• Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)