Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Sucampo Pharmaceuticals, Inc. Takeda Pharmaceutical Company Limited |
---|---|
Information provided by: | Sucampo Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00452335 |
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 |
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)
|
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Paul Hyman, MD | University of Kansas |
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 |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |