Lubiprostone for Children With Constipation

Sucampo

Status and phase: Completed; Phase 3

Conditions: Constipation - Functional

Treatments: Drug: Lubiprostone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02138136

SAG-0211PFC-11S1

2013-004384-31 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 419 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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419 participants in 1 patient group

Lubiprostone

Experimental group

Description:

Participants receive lubiprostone twice daily Participants must have completed the entire 12-week treatment period during the preceding study. Those who received 12 mcg twice daily (BID) continued to receive 12 mcg, those who received 24 mcg BID continued with that dose.Those of the placebo arm in the previous study weighing less than 50 kg received 12 mcg BID and over 50 kg received 24 mcg BID during this study.

Treatment:

Drug: Lubiprostone