NCT02766777

Brief Summary

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 6, 2016

Results QC Date

May 4, 2020

Last Update Submit

May 4, 2020

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

    Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.

    within 25 weeks

Study Arms (1)

Lubiprostone

EXPERIMENTAL

Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.

Drug: Lubiprostone

Interventions

LubiprostoneDRUG

12 or 24 mcg soft capsules for oral administration.

Also known as: Amitiza
Lubiprostone

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
  • At least 6 years of age but less than 18 years of age at the time of randomisation
  • Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants

You may not qualify if:

  • Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
  • Untreated faecal impaction at the time of screening
  • Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Northwest Arkansas Pediatric Clinic

Fayetteville, Arkansas, 72703, United States

Location

Methodist Medical Center

Peoria, Illinois, 61602, United States

Location

Willis-Knighton Physician Network

Shreveport, Louisiana, 71101, United States

Location

Pioneer Clinical Research

Bellevue, Nebraska, 68005, United States

Location

PriMed Clinical Research

Beavercreek, Ohio, 45431, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Coastal Clinical Research

Charleston, South Carolina, 29414, United States

Location

Coastal Pediatrics Associates - Mount Pleasant

Mt. Pleasant, South Carolina, 29464, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

3rd Coast Research Associates

Corpus Christi, Texas, 78413, United States

Location

Bridgerland Clinical Research

Logan, Utah, 84341, United States

Location

Wee Care Pediatrics

Syracuse, Utah, 84075, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

AlprostadilFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Results Point of Contact

Title
Medical Information Call Center
Organization
Mallinckrodt Pharmaceuticals
clinicaltrials@mnk.com
800-556-3314

Study Officials

  • Clinical Team Leader

    Mallinckrodt

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

April 12, 2016

Primary Completion

November 4, 2016

Study Completion

November 4, 2016

Last Updated

May 15, 2020

Results First Posted

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(13)