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Lubiprostone in Children With Functional Constipation

NCT02042183 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2020-07-21

Study results available
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Summary

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Conditions

  • Constipation - Functional

Interventions

DRUG

Lubiprostone

12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1

DRUG

Placebo

0 mcg soft capsules of placebo for oral administration

Sponsors & Collaborators

  • Sucampo AG

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-13
Primary Completion
2016-07-27
Completion
2016-07-27
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT02042183 on ClinicalTrials.gov