Clinical trial NCT00452335: Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Official title: A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo Pharmaceuticals, Inc.
First posted: 2007-03-27
Enrollment: 127
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Spontaneous Bowel Movements
timeFrame: Week 1
Secondary outcomes:
measure: Frequency of Spontaneous Bowel Movements
timeFrame: Weeks 2, 3, and 4
measure: Frequency of Fecal Incontinence
timeFrame: Weekly, up to 4 weeks
measure: Straining Associated With SBMs
timeFrame: Weekly, up to 4 weeks
measure: Stool Consistency of SBMs
timeFrame: Weekly, up to 4 weeks
measure: Abdominal Bloating
timeFrame: Weekly, up to 4 weeks
measure: Abdominal Discomfort
timeFrame: Weekly, up to 4 weeks
measure: Pain Associated With SBMs
timeFrame: Weekly, up to 4 weeks
measure: Constipation Severity
timeFrame: Weekly, up to 4 weeks
measure: Treatment Effectiveness
timeFrame: Weekly, up to 4 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Oakland
country: United States
facility: Children's Hospital and Research Center Oakland
state: California
city: Jacksonville
country: United States
facility: Nemours Children's Clinic - Jacksonville
state: Florida
city: Pensacola
country: United States
facility: Nemours Children's Clinic - Pensacola
state: Florida
city: Park Ridge
country: United States
facility: Center for Children's Digestive Health
state: Illinois
city: Peoria
country: United States
facility: University of Illinois at Peoria
state: Illinois
city: Springfield
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Omaha
country: United States
facility: The Center for Human Nutrition, Inc.
state: Nebraska
city: Morristown
country: United States
facility: AHS Hospital Corporation
state: New Jersey
city: Columbus
country: United States
facility: Children's Research Institute
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc.
state: Ohio
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeastern Clinical Research
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Kansas Medical Center
name: Paul Hyman, MD
role: PRINCIPAL_INVESTIGATOR
References: