Lubiprostone in Children With Functional Constipation

Study Overview
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Brief Summary
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Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Detailed Description
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Dose administration details: Participants with a body weight <50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID. Participants with a body weight >50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

Official Title
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A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

Conditions
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Constipation - Functional

Intervention / Treatment
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* Drug: Lubiprostone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 subject is taking antidepressants Exclusion Criteria: Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubiprostone<br>Participants receive lubiprostone twice daily (BID) up to 12 weeks | Drug: Lubiprostone<br>* 12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1<br>* Other names: Amitiza;|
| Placebo Comparator: Placebo<br>Participants receive placebo BID up to 12 weeks | Drug: Placebo<br>* 0 mcg soft capsules of placebo for oral administration<br>* Other names: Matching Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Classified as Overall Responders at Week 12 | An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline. | at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of SBMs Observed Each Week for 12 Weeks | Data provided is based on observed cases. Baseline is the average of the 2 weeks before being randomized. Participants are summarized by actual dose received after week 1. | within 12 Weeks |