Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation - Full Text View

Sponsors and Collaborators:	Sucampo Pharmaceuticals, Inc. Takeda Pharmaceutical Company Limited
Information provided by:	Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00452335

Purpose

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.

Condition	Intervention	Phase
Constipation	Drug: Lubiprostone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Constipation

Drug Information available for: Lubiprostone

U.S. FDA Resources

Further study details as provided by Sucampo Pharmaceuticals, Inc.:

Primary Outcome Measures:

Frequency of Spontaneous Bowel Movements [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bowel Movement Timing and Frequency Rates [ Time Frame: Daily and weekly ] [ Designated as safety issue: No ]
Frequency of Fecal Incontinence [ Time Frame: Daily and weekly ] [ Designated as safety issue: No ]
Bowel Habit Assessments [ Time Frame: Daily and weekly ] [ Designated as safety issue: No ]
Abdominal Assessments [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Treatment Effectiveness [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment:	127
Study Start Date:	January 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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	Drug: Lubiprostone 12 mcg capsule once daily (QD)
2: Experimental 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	Drug: Lubiprostone 12 mcg capsule twice daily (BID)
3: Experimental Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight	Drug: Lubiprostone 24 mcg capsule twice daily (BID)

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Hirshsprung'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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452335

Locations

United States, Arizona
Phoenix Children's Hospital
Pheonix, Arizona, United States, 85016
United States, Arkansas
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72005
United States, California
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
United States, Florida
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207
United States, Illinois
Center for Children's Digestive Health
Park Ridge, Illinois, United States, 60068
University of Illinois at Chicago
Springfield, Illinois, United States, 62708-0787
University of Illinois at Peoria
Peoria, Illinois, United States, 61613
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Nebraska
The Center for Human Nutrition, Inc.
Omaha, Nebraska, United States, 68105
United States, New Jersey
AHS Hospital Corporation
Morristown, New Jersey, United States, 07962
United States, Ohio
Children's Research Institute
Columbus, Ohio, United States, 43205
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
Southeastern Clinical Research
Chattanooga, Tennessee, United States, 37403
Jackson Clinic
Jackson, Tennessee, United States, 38305
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Sucampo Pharmaceuticals, Inc.

Takeda Pharmaceutical Company Limited

Investigators

Principal Investigator:

Paul Hyman, MD

University of Kansas

More Information

No publications provided

Responsible Party:	Sucampo Pharmaceuticals, Inc. ( Director, Clinical Development )
Study ID Numbers:	0211SC-0641
Study First Received:	March 26, 2007
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00452335 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

ClinicalTrials.gov processed this record on September 10, 2009