Lubiprostone for Children With Constipation

Phase 3

Completed

• Conditions: Constipation - Functional
• Interventions: Drug: Lubiprostone

• Registration Number: NCT02138136
• Lead Sponsor: Sucampo Pharma Americas, LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-26
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Results First Submitted: 2019-12-13
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Results First Posted: 2020-01-21
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lubiprostone	Lubiprostone	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.

Primary Outcome Measures

Name	Time	Method
Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month	within 9 months	Spontaneous bowel movements are defined as bowel movements without the aid of drugs.

Trial Locations

Locations (85)

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

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