search
Back to results

Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Primary Purpose

Constipation - Functional

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Northwest Arkansas Pediatric Clinic
  • Methodist Medical Center
  • Willis-Knighton Physician Network
  • Pioneer Clinical Research
  • PriMed Clinical Research
  • Cyn3rgy Research
  • Coastal Clinical Research
  • Coastal Pediatrics Associates - Mount Pleasant
  • Spartanburg Medical Research
  • 3rd Coast Research Associates
  • Bridgerland Clinical Research
  • Wee Care Pediatrics
  • Pediatric Research of Charlottesville, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lubiprostone

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2016
Last Updated
May 4, 2020
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo AG
search

1. Study Identification

Unique Protocol Identification Number
NCT02766777
Brief Title
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
Official Title
A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 12, 2016 (Actual)
Primary Completion Date
November 4, 2016 (Actual)
Study Completion Date
November 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.
Detailed Description
To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
12 or 24 mcg soft capsules for oral administration.
Primary Outcome Measure Information:
Title
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Description
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.
Time Frame
within 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Arkansas Pediatric Clinic
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Methodist Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Willis-Knighton Physician Network
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Pioneer Clinical Research
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
PriMed Clinical Research
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Coastal Clinical Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Coastal Pediatrics Associates - Mount Pleasant
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
3rd Coast Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
Bridgerland Clinical Research
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Wee Care Pediatrics
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

We'll reach out to this number within 24 hrs