Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
- Registration Number
- NCT00452335
- Lead Sponsor
- Sucampo Pharma Americas, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lubiprostone 12 mcg BID Lubiprostone 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 Lubiprostone 12 mcg QD Lubiprostone 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 Lubiprostone 24 mcg BID Lubiprostone Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
- Primary Outcome Measures
Name Time Method Frequency of Spontaneous Bowel Movements Week 1 Gathered as part of the daily electronic diary questions.
- Secondary Outcome Measures
Name Time Method Frequency of Spontaneous Bowel Movements Weeks 2, 3, and 4 Gathered as part of the daily electronic diary questions.
Constipation Severity 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.
Treatment Effectiveness 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.
Frequency of Fecal Incontinence Weekly, up to 4 weeks As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.
Straining Associated With SBMs 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.
Stool Consistency of SBMs 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.
Abdominal Bloating 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.
Abdominal Discomfort 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.
Pain Associated With SBMs 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.
Trial Locations
- Locations (19)
University of Illinois at Chicago
🇺🇸Springfield, Illinois, United States
Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
AHS Hospital Corporation
🇺🇸Morristown, New Jersey, United States
Pediatric Associates of Fairfield, Inc.
🇺🇸Fairfield, Ohio, United States
Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Children's Hospital and Research Center Oakland
🇺🇸Oakland, California, United States
The Center for Human Nutrition, Inc.
🇺🇸Omaha, Nebraska, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Center for Children's Digestive Health
🇺🇸Park Ridge, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Children's Research Institute
🇺🇸Columbus, Ohio, United States
Southeastern Clinical Research
🇺🇸Chattanooga, Tennessee, United States
University of Illinois at Peoria
🇺🇸Peoria, Illinois, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Nemours Children's Clinic - Pensacola
🇺🇸Pensacola, Florida, United States
Nemours Children's Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States