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OpenTrials
Completed

NCT Number: NCT02138136

Lubiprostone for Children With Constipation

This study is for children with constipation.

Children who completed 3 months of treatment in the earlier study (NCT02042183):

* were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year

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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

Universitair Kinderziekenhuis Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has completed the 3-month placebo-controlled study (NCT02042183)
  • Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility

Exclusion criteria

  • Has untreated faecal impaction at the time of rolling over into study
  • Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
  • Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)

Treatment and study plan

Lubiprostone

Drug

12 or 24 mcg soft capsules for oral administration

Other names: Amitiza®

Primary outcomes

  1. Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month

    Time frame: within 9 months

    Spontaneous bowel movements are defined as bowel movements without the aid of drugs.

Other outcomes

  1. Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs

    Time frame: within 9 months

    Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse.

  2. Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs

    Time frame: within 9 months

    Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome.

  3. Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain

    Time frame: within 9 months

    Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome.

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Takeda

Registry information

Official study title

A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 14, 2014
Registry last updated
Jan 21, 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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