Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

Sucampo

Status and phase

Completed

Phase 4

Conditions

Constipation

Treatments

Drug: Lubiprostone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00452335

0211SC-0641

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

Enrollment

127 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Less than 18 years of age
Weight of at least 12 kg and capable of swallowing a capsule
Able to refrain from use of medications known to treat or associated with constipation symptoms
Stable fiber therapy or ADHD therapy if using such medications
Patient/Caregiver able to complete daily diary
Patient able to use recommended rectal and/or oral rescue medications if needed

Exclusion criteria

Constipation is associated with some medical, anatomic, physical, organic, or other condition
Hirschsprung's Disease or Nonretentive Fecal Incontinence
Untreated fecal impactions or impactions requiring digital manipulation
Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Sexually active males and females must utilize acceptable birth control methods
Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

127 participants in 3 patient groups

Lubiprostone 12 mcg QD

Experimental group

Description:

Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\<6 years of age and able to swallow capsules) who are at least 12 kg body weight

Treatment:

Drug: Lubiprostone

Lubiprostone 12 mcg BID

Experimental group

Description:

Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight

Treatment:

Drug: Lubiprostone

Lubiprostone 24 mcg BID

Experimental group

Description:

Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight