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NCT Number: NCT02766777

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

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

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Key information

Conditions

Constipation - Functional

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northwest Arkansas Pediatric Clinic, Fayetteville, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lubiprostone

Drug

12 or 24 mcg soft capsules for oral administration.

Other names: Amitiza

Primary outcomes

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

    Time frame: within 25 weeks

    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.

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Sucampo AG

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 10, 2016
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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