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Lubiprostone for Children With Constipation

NCT02138136 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2020-01-21

Study results available
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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

Conditions

  • Constipation - Functional

Interventions

DRUG

Lubiprostone

12 or 24 mcg soft capsules for oral administration

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-26
Primary Completion
2017-05-01
Completion
2017-05-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138136 on ClinicalTrials.gov