Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:2 - 17
Updated:10/14/2017
Start Date:January 2007
End Date:October 2008

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A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation

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.


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
We found this trial at
19
sites
One William Maxwell Lane
Springfield, Illinois 62708
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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Oakland, CA
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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Pensacola, FL
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Boston, Massachusetts 02115
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Boston, MA
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Chattanooga, Tennessee 37403
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Chattanooga, TN
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700 Children's Drive
Columbus, Ohio 43205
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Columbus, OH
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Fairfield, Ohio 45014
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Fairfield, OH
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Jackson, Tennessee 38301
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Jackson, TN
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Jacksonville, Florida 32207
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Jacksonville, FL
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, KS
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Lancaster, PA
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Little Rock, Arkansas 72205
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Little Rock, AR
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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100 Madison Avenue
Morristown, New Jersey 07962
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Morristown, NJ
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Omaha, Nebraska 68105
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Omaha, NE
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Park Ridge, Illinois 60068
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Park Ridge, IL
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4810 North Sheridan Road
Peoria, Illinois 61613
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Peoria, IL
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Pheonix, Arizona 85016
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Pheonix, AZ
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