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Lubiprostone in Children With Functional Constipation

S

Sucampo

Status and phase

Completed
Phase 3

Conditions

Constipation - Functional

Treatments

Drug: Placebo
Drug: Lubiprostone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02042183
EMEA-000245-PIP01-08 (Other Identifier)
SAG/0211PFC-1131
2013-004384-31 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

606 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No 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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

606 participants in 2 patient groups, including a placebo group

Lubiprostone
Experimental group
Description:
Participants receive lubiprostone twice daily (BID) up to 12 weeks
Treatment:
Drug: Lubiprostone
Placebo
Placebo Comparator group
Description:
Participants receive placebo BID up to 12 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

117

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Data sourced from clinicaltrials.gov

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