Lubiprostone for Children With Constipation

Completed · Phase 3

Conditions studied: Constipation - Functional

In brief

This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): * were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year

Key facts

Study ID

NCT02138136

Run by

Sucampo Pharma Americas, LLC

People needed

419

Starts

2014-02-26

Expected to finish

2017-05-01

Last updated by the study team

2020-01-21

Who can join

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

You may qualify if…

• Has completed the 3-month placebo-controlled study (NCT02042183)
• Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility

You may not qualify if…

• Has untreated faecal impaction at the time of rolling over into study
• Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
• Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)

Where it is running

• 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 Childrens Hospital Research Institute — 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
• 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
• Nemours Childrens Clinic — Pensacola, Florida, United States
• Children's Center for Digestive Health Care/GI Care for Kids — Atlanta, Georgia, United States
• Methodist Medical Center — Peoria, Illinois, United States
• PediaResearch, LLC - Newburgh — Newburgh, Indiana, United States
• UnityPoint Health Des Moines/ Blank Children's Clinic — Des Moines, Iowa, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• Heartland Research Associates — Wichita, Kansas, United States
• University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
• University of South Alabama Women's and Children's Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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