Lubiprostone in Children With Functional Constipation

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