Lubiprostone for Children With Constipation

Sucampo Pharma Americas, LLC419 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

419

Conditions

Constipation - Functional

Interventions

LubiprostoneDRUG

12 or 24 mcg soft capsules for oral administration

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (85)

Outcomes

Primary Outcomes

Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month

Spontaneous bowel movements are defined as bowel movements without the aid of drugs.

Time frame: within 9 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University of South Alabama Women's and Children's Hospital

Mobile, Alabama, United States

Arizona Children's Center at Maricopa Medical Center

Phoenix, Arizona, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Northwest Arkansas Pediatric Clinic

Fayetteville, Arkansas, United States

Arkansas Childrens Hospital Research Institute

Little Rock, Arkansas, United States

WCCT Global

Costa Mesa, California, United States

Loma Linda University Health Care

Loma Linda, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

MCB Clinical Research

Colorado Springs, Colorado, United States

...and 75 more locations