- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00452335
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
December 13, 2019 updated by: Sucampo Pharma Americas, LLC
A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85016
- Phoenix Children's Hospital
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72005
- Arkansas Pediatric Clinic
-
-
California
-
Oakland, California, United States, 94609
- Children's Hospital and Research Center Oakland
-
-
Florida
-
Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic - Jacksonville
-
Pensacola, Florida, United States, 32504
- Nemours Children's Clinic - Pensacola
-
-
Illinois
-
Park Ridge, Illinois, United States, 60068
- Center for Children's Digestive Health
-
Peoria, Illinois, United States, 61613
- University of Illinois at Peoria
-
Springfield, Illinois, United States, 62708-0787
- University of Illinois at Chicago
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Nebraska
-
Omaha, Nebraska, United States, 68105
- The Center for Human Nutrition, Inc.
-
-
New Jersey
-
Morristown, New Jersey, United States, 07962
- AHS Hospital Corporation
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Children's Research Institute
-
Fairfield, Ohio, United States, 45014
- Pediatric Associates of Fairfield, Inc.
-
-
Pennsylvania
-
Lancaster, Pennsylvania, United States, 17604
- Regional Gastroenterology Associates of Lancaster, Ltd.
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- Southeastern Clinical Research
-
Jackson, Tennessee, United States, 38305
- Jackson Clinic
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Less than 18 years of age
- Weight of at least 12 kg and capable of swallowing a capsule
- Able to refrain from use of medications known to treat or associated with constipation symptoms
- Stable fiber therapy or ADHD therapy if using such medications
- Patient/Caregiver able to complete daily diary
- Patient able to use recommended rectal and/or oral rescue medications if needed
Exclusion Criteria:
- Constipation is associated with some medical, anatomic, physical, organic, or other condition
- Hirschsprung's Disease or Nonretentive Fecal Incontinence
- Untreated fecal impactions or impactions requiring digital manipulation
- Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
- Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
- Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
- If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
- Sexually active males and females must utilize acceptable birth control methods
- Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lubiprostone 12 mcg QD
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
|
12 mcg capsule once daily (QD)
Other Names:
12 mcg capsule twice daily (BID)
Other Names:
24 mcg capsule twice daily (BID)
Other Names:
|
Experimental: Lubiprostone 12 mcg BID
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
|
12 mcg capsule once daily (QD)
Other Names:
12 mcg capsule twice daily (BID)
Other Names:
24 mcg capsule twice daily (BID)
Other Names:
|
Experimental: Lubiprostone 24 mcg BID
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
|
12 mcg capsule once daily (QD)
Other Names:
12 mcg capsule twice daily (BID)
Other Names:
24 mcg capsule twice daily (BID)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Spontaneous Bowel Movements
Time Frame: Week 1
|
Gathered as part of the daily electronic diary questions.
|
Week 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Spontaneous Bowel Movements
Time Frame: Weeks 2, 3, and 4
|
Gathered as part of the daily electronic diary questions.
|
Weeks 2, 3, and 4
|
Frequency of Fecal Incontinence
Time Frame: Weekly, up to 4 weeks
|
As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.
|
Weekly, up to 4 weeks
|
Straining Associated With SBMs
Time Frame: Weekly, up to 4 weeks
|
Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.
|
Weekly, up to 4 weeks
|
Stool Consistency of SBMs
Time Frame: Weekly, up to 4 weeks
|
Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.
|
Weekly, up to 4 weeks
|
Abdominal Bloating
Time Frame: Weekly, up to 4 weeks
|
Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Weekly, up to 4 weeks
|
Abdominal Discomfort
Time Frame: Weekly, up to 4 weeks
|
Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Weekly, up to 4 weeks
|
Pain Associated With SBMs
Time Frame: Weekly, up to 4 weeks
|
Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.
|
Weekly, up to 4 weeks
|
Constipation Severity
Time Frame: Weekly, up to 4 weeks
|
Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Weekly, up to 4 weeks
|
Treatment Effectiveness
Time Frame: Weekly, up to 4 weeks
|
Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.
|
Weekly, up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Hyman, MD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
March 26, 2007
First Submitted That Met QC Criteria
March 26, 2007
First Posted (Estimate)
March 27, 2007
Study Record Updates
Last Update Posted (Actual)
December 17, 2019
Last Update Submitted That Met QC Criteria
December 13, 2019
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0211SC-0641
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation
-
usMIMA S.L.CompletedConstipation | Constipation Chronic Idiopathic | Constipation; NeurogenicSpain, United Kingdom
-
AbbVieIronwood Pharmaceuticals, Inc.RecruitingFunctional Constipation (FC) | Chronic Idiopathic Constipation (CIC)United States, United Kingdom, Bulgaria
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
ProgenaBiomeRecruitingConstipation | Constipation - Functional | Constipation Chronic Idiopathic | Constipation (Excl Faecal Impaction)United States
-
Pamukkale UniversityRecruiting
-
Shanghai University of Traditional Chinese MedicineLonghua Hospital; Shanghai Municipal Hospital of Traditional Chinese MedicineRecruiting
-
Universidade Nova de LisboaCINTESIS - Center for Health Technology and Services ResearchRecruiting
-
United PharmaceuticalsDelta ConsultantsRecruitingFunctional ConstipationItaly
-
King's College LondonImperial College London; Queen Mary University of LondonRecruitingConstipation - FunctionalUnited Kingdom
-
Children's Hospital Los AngelesTerminatedFunctional ConstipationUnited States
Clinical Trials on Lubiprostone
-
Sucampo Pharma Americas, LLCTakedaCompletedHealthy VolunteersUnited States
-
Baylor College of MedicineUniversity of South FloridaCompletedParkinson's DiseaseUnited States
-
Texas Tech University Health Sciences Center, El...Completed
-
Dartmouth-Hitchcock Medical CenterTakeda Pharmaceuticals North America, Inc.CompletedChronic Idiopathic ConstipationUnited States
-
University of ArkansasTakeda Pharmaceuticals North America, Inc.CompletedConstipation | Cystic FibrosisUnited States
-
Helwan UniversityCompleted
-
University of South AlabamaTakeda; Sucampo Pharmaceuticals, Inc.TerminatedConstipationUnited States
-
Brooke Army Medical CenterTakedaCompletedBowel Preparation for ColonoscopyUnited States
-
Henry Ford Health SystemTakeda Pharmaceuticals North America, Inc.CompletedColonoscopyUnited States
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); T... and other collaboratorsCompleted