Lubiprostone in Children With Functional Constipation

Completed · Phase 3 · Has a placebo group

Conditions studied: Constipation - Functional

In brief

Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Key facts

Study ID

NCT02042183

Run by

Sucampo Pharma Americas, LLC

People needed

606

Starts

2013-12-13

Expected to finish

2016-07-27

Last updated by the study team

2020-07-21

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
• At least 6 years of age but less than 18 years of age at the time of randomisation
• Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if subject is taking antidepressants

You may not qualify if…

• Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), affecting GI motility or defecation
• Untreated faecal impaction at the time of screening
• Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication

Where it is running

• University of South Alabama Women's and Children's Hospital — Mobile, Alabama, United States
• Arizona Children's Center at Maricopa Medical Center — Phoenix, Arizona, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Northwest Arkansas Pediatric Clinic — Fayetteville, Arkansas, United States
• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• Applied Clinical Research of Arkansas — Little Rock, Arkansas, United States
• WCCT Global — Costa Mesa, California, United States
• Loma Linda University Health Care — Loma Linda, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California, San Francisco — San Francisco, California, United States
• MCB Clinical Research — Colorado Springs, Colorado, United States
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Emmerson Clinical Research — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Palmetto Professional Research — Hialeah, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Acevedo Clinical Research Associates — Miami, Florida, United States
• Savin Medical Group Research Center — Miami Lakes, Florida, United States
• Digestive & Liver Center of Florida — Orlando, Florida, United States
• Nemours Childrens Clinic — Pensacola, Florida, United States
• Children's Center for Digestive Healthcare/GI Care for Kids — Atlanta, Georgia, United States
• Center For Children's Digestive Health — Park Ridge, Illinois, United States
• Methodist Medical Center — Peoria, Illinois, United States
• University of Alabama Pediatric Gastroenterology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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