Constipation - Functional Clinical Trial
Official title:
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
| Verified date | July 2020 |
| Source | Mallinckrodt |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
| Status | Completed |
| Enrollment | 606 |
| Est. completion date | July 27, 2016 |
| Est. primary completion date | July 27, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Universitair Kinderziekenhuis Brussel | Brussel | |
| Belgium | University Hospital Gasthuisberg | Leuven | |
| Belgium | CHC - Clinique Saint-Joseph | Montegnee | |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Sainte Justine University Health Center | Montreal | |
| Canada | Centre de recherche du CHUS | Sherbrooke | Quebec |
| France | CHU-Bordeaux | Bordeaux | |
| France | Groupe Hospitalier Est | Bron | |
| France | Armand-Trousseau Teaching Hospital | Paris | |
| France | Hôpital Necker | Paris-Cedex | |
| 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 | ATOPIA Poradnie Specjalistyczne | Krakow | |
| Poland | Medical University of Lodz | Lodz | |
| Poland | Szpital Pediatryczny ICZMP | Lodz | |
| Poland | Gabinet Lekarski Bartosc Korczowski | Rzeszow | |
| Poland | Children's Memorial Health Institute | Warszaw | |
| Poland | Children's Memorial Health Institute | Warszaw | |
| Poland | Przychodnia Specjalistyczna PROSEN | Warszawa | |
| United Kingdom | Kent and Canterbury Hospital | Canterbury | |
| United Kingdom | Darlington Memorial Hospital | Darlington | |
| United Kingdom | Royal Hospital for Sick Children | Glasgow | |
| United Kingdom | Chelsea and Westminster Hospital NHS Foundation Trust | London | |
| United Kingdom | Great Ormond Street Hospital for children NHS Foundation Trust | London | |
| United Kingdom | Royal London Hospital | London | |
| United Kingdom | Sheffield Children Hospital | Sheffield | |
| United States | Texas Tech University Health Sciences Center | Amarillo | Texas |
| United States | Children's Center for Digestive Healthcare/GI Care for Kids | Atlanta | Georgia |
| United States | Austin Center for Clinical Research | Austin | Texas |
| United States | Johns Hopkins Children's Center | Baltimore | Maryland |
| United States | A1 Clinical Research | Baytown | Texas |
| 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 Alabama Pediatric Gastroenterology | Birmingham | Alabama |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo | Buffalo | New York |
| United States | University of Vermont Medical Center | Burlington | Vermont |
| United States | UNC School of Medicine | Chapel Hill | North Carolina |
| 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 | Midwest Children's Health Research Institute | Lincoln | Nebraska |
| United States | Applied Clinical Research of Arkansas | Little Rock | Arkansas |
| United States | Arkansas Children's 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 | Le Bonheur Children's Hospital | Memphis | Tennessee |
| 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 | Monroe Carell Junior Children's Hospital at Vanderbilt | Nashville | Tennessee |
| United States | Children's Hospital | New Orleans | Louisiana |
| 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 | The Children's Hospital of the King's Daughter | Norfolk | Virginia |
| United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Children's Hospital of Orange County | Orange | California |
| United States | Digestive & Liver Center of Florida | Orlando | Florida |
| United States | PediaResearch, LLC - Owensboro | Owensboro | Kentucky |
| United States | Center For Children's Digestive Health | Park Ridge | Illinois |
| United States | Nemours Childrens Clinic | Pensacola | Florida |
| United States | Methodist Medical Center | Peoria | Illinois |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| 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 | Mayo Clinic | Rochester | Minnesota |
| United States | Primary Children's Medical Center | Salt Lake City | Utah |
| United States | University of California, San Francisco | San Francisco | California |
| United States | Medical Clinics of Sealy | Sealy | Texas |
| 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 | Sucampo AG |
United States, Belgium, Canada, France, Netherlands, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Classified as Overall Responders at Week 12 | An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline. | at Week 12 | |
| Secondary | Mean Number of SBMs Observed Each Week for 12 Weeks | Data provided is based on observed cases. Baseline is the average of the 2 weeks before being randomized. Participants are summarized by actual dose received after week 1. | within 12 Weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05032534 -
Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
|
N/A | |
| Completed |
NCT04587635 -
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults With Constipation
|
N/A | |
| Completed |
NCT03821532 -
Adherence/Outcomes After Use of Constipation Action Plan
|
N/A | |
| Recruiting |
NCT06122558 -
Efficacy of Probiotic Against Functional Constipation
|
Phase 2 | |
| Recruiting |
NCT04086134 -
Physiological, Microbiological and Metabolomic Effects of Fruit Products
|
N/A | |
| Recruiting |
NCT01587846 -
Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children
|
Phase 3 | |
| Recruiting |
NCT05496543 -
Acupuncture for Functional Constipation in Older Adults
|
N/A | |
| Completed |
NCT05447481 -
Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults
|
N/A | |
| Completed |
NCT05035784 -
RCE With FMT in the Treatment of Childhood Constipation
|
N/A | |
| Recruiting |
NCT06221722 -
Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation
|
||
| Suspended |
NCT04306939 -
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
|
||
| Recruiting |
NCT05823259 -
The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
|
N/A | |
| Not yet recruiting |
NCT06438068 -
Influence of Modern Colon Hydrotherapy on Intestinal Transit
|
N/A | |
| Withdrawn |
NCT05321953 -
The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation
|
N/A | |
| Active, not recruiting |
NCT05363553 -
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
|
N/A | |
| Recruiting |
NCT06031025 -
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
|
||
| Recruiting |
NCT05432453 -
The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
|
||
| Not yet recruiting |
NCT05191810 -
Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children
|
N/A | |
| Not yet recruiting |
NCT06100055 -
The ReVo Study: Low-volume vs High-volume Rectal Irrigation
|
N/A | |
| Recruiting |
NCT04148248 -
A Pilot Study to Explore the Role of Gut Flora in Chronic Constipation
|