Constipation - Functional Clinical Trial
Official title:
A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
| Verified date | January 2020 |
| Source | Mallinckrodt |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 419 |
| Est. completion date | May 1, 2017 |
| Est. primary completion date | May 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Universitair Kinderziekenhuis Brussel | Brussel | |
| Belgium | CHC - Clinique Saint-Joseph | Montegnee | |
| Canada | Sainte Justine University Health Center | Montreal | |
| France | CHU-Bordeaux | Bordeaux | |
| Netherlands | Emma Children's Hospital | Amsterdam | |
| Netherlands | Amphia Ziekenhuis | Breda | |
| Netherlands | Maasstad Hospital Rotterdam | Rotterdam | |
| Netherlands | Isala Klinieken | Zwolle | |
| Poland | Medical University of Bialystok | Bialystok | |
| Poland | Szpital Uniwersytecki | Bydgoszcz | |
| Poland | Szpital Pediatryczny ICZMP | Lodz | |
| Poland | Gabinet Lekarski Bartosc Korczowski | Rzeszow | |
| Poland | Children's Memorial Health Institute | Warszaw | |
| Poland | Przychodnia Specjalistyczna PROSEN | Warszawa | |
| United Kingdom | Darlington Memorial Hospital | Darlington | |
| United Kingdom | Chelsea and Westminster Hospital NHS Foundation Trust | London | |
| United Kingdom | Royal London Hospital | London | |
| United Kingdom | Sheffield Children Hospital | Sheffield | |
| United States | Children's Center for Digestive Health Care/GI Care for Kids | Atlanta | Georgia |
| United States | PriMed Clinical Research | Beavercreek | Ohio |
| United States | Northwest Clinicial Research Center | Bellevue | Washington |
| United States | Pioneer Clinical Research | Bellevue | Nebraska |
| United States | University of Vermont Medical Center | Burlington | Vermont |
| United States | Coastal Clinical Research | Charleston | South Carolina |
| United States | Coastal Pediatric Associates - James Island | Charleston | South Carolina |
| United States | Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia |
| United States | MCB Clinical Research | Colorado Springs | Colorado |
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | 3rd Coast Research Associates | Corpus Christi | Texas |
| United States | WCCT Global | Costa Mesa | California |
| United States | Childrens Medical Center Dallas | Dallas | Texas |
| United States | UnityPoint Health Des Moines/ Blank Children's Clinic | Des Moines | Iowa |
| United States | Square-1 Clinical Research, Inc. | Erie | Pennsylvania |
| United States | INOVA Pediatric Digestive Diseases Center | Fairfax | Virginia |
| United States | Northwest Arkansas Pediatric Clinic | Fayetteville | Arkansas |
| United States | Cook Children's Medical Center | Fort Worth | Texas |
| United States | University of Florida | Gainesville | Florida |
| United States | Greenville Health System | Greenville | South Carolina |
| United States | Cyn3rgy Research | Gresham | Oregon |
| United States | Palmetto Professional Research | Hialeah | Florida |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | University of Iowa Children's Hospital | Iowa City | Iowa |
| United States | Gastrointestinal Associates, PA | Jackson | Mississippi |
| United States | The Jackson Clinic, P.C. | Jackson | Tennessee |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | Smart Medical Research, Inc. | Jackson Heights | New York |
| United States | Nemours Children's Clinic | Jacksonville | Florida |
| United States | The Children's Mercy Hospital | Kansas City | Missouri |
| United States | Envision Clinical Research, LLC | Laredo | Texas |
| United States | Arkansas Childrens Hospital Research Institute | Little Rock | Arkansas |
| United States | Bridgerland Clinical Research | Logan | Utah |
| United States | Loma Linda University Health Care | Loma Linda | California |
| United States | DCOL Center for Clinical Research | Longview | Texas |
| United States | Children's Hospital Los Angeles | Los Angeles | California |
| United States | University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky |
| United States | Acevedo Clinical Research Associates | Miami | Florida |
| United States | Savin Medical Group Research Center | Miami Lakes | Florida |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | University of South Alabama Women's and Children's Hospital | Mobile | Alabama |
| United States | Coastal Pediatrics Associates - Mount Pleasant | Mount Pleasant | South Carolina |
| United States | Morgan Stanley Children's Hospital of New York Presbyterian | New York | New York |
| United States | NY Presbyterian Weill Cornell | New York | New York |
| United States | PediaResearch, LLC - Newburgh | Newburgh | Indiana |
| United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | PediaResearch, LLC - Owensboro | Owensboro | Kentucky |
| United States | Nemours Childrens Clinic | Pensacola | Florida |
| United States | Methodist Medical Center | Peoria | Illinois |
| United States | St. Christopher's Hospital for Children Drexel University | Philadelphia | Pennsylvania |
| United States | Arizona Children's Center at Maricopa Medical Center | Phoenix | Arizona |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Children's Hospital of Pittsburgh UPMC | Pittsburgh | Pennsylvania |
| United States | Zain Research LLC | Richland | Washington |
| United States | Pediatric Gastroenterology Carilion Medical Center | Roanoke | Virginia |
| United States | Primary Children's Medical Center | Salt Lake City | Utah |
| United States | University of California, San Francisco | San Francisco | California |
| United States | Willis-Knighton Physician Network | Shreveport | Louisiana |
| United States | Virgo-Carter Pediatrics | Silver Spring | Maryland |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | Wee Care Pediatrics | Syracuse | Utah |
| United States | MultiCare Health System Institute for Research and Innovation | Tacoma | Washington |
| United States | Toledo Children's Hospital | Toledo | Ohio |
| United States | AAPRI Clinical Research | Warwick | Rhode Island |
| United States | Emmerson Clinical Research | Washington | District of Columbia |
| United States | Heartland Research Associates | Wichita | Kansas |
| United States | Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Sucampo Pharma Americas, LLC | Takeda |
United States, Belgium, Canada, France, Netherlands, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse. | within 9 months | |
| Other | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome. | within 9 months | |
| Other | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome. | within 9 months | |
| Primary | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Spontaneous bowel movements are defined as bowel movements without the aid of drugs. | within 9 months |
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