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

Constipation - Functional Clinical Trial

Official title:

A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766777
• Other study ID #: SCMP-0211-303
• Status: Completed
• Phase: Phase 3
• Start date: April 12, 2016
• Est. completion date: November 4, 2016

Study information

• Verified date: May 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 4, 2016
• Est. primary completion date: November 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Drug:
• Lubiprostone
12 or 24 mcg soft capsules for oral administration.

Locations

Country	Name	City	State
United States	PriMed Clinical Research	Beavercreek	Ohio
United States	Pioneer Clinical Research	Bellevue	Nebraska
United States	Coastal Clinical Research	Charleston	South Carolina
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	3rd Coast Research Associates	Corpus Christi	Texas
United States	Northwest Arkansas Pediatric Clinic	Fayetteville	Arkansas
United States	Cyn3rgy Research	Gresham	Oregon
United States	Bridgerland Clinical Research	Logan	Utah
United States	Coastal Pediatrics Associates - Mount Pleasant	Mount Pleasant	South Carolina
United States	Methodist Medical Center	Peoria	Illinois
United States	Willis-Knighton Physician Network	Shreveport	Louisiana
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Wee Care Pediatrics	Syracuse	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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