Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

Constipation Clinical Trial

Official title:

A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452335
• Other study ID #: 0211SC-0641
• Status: Completed
• Phase: Phase 4
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: July 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Lubiprostone
12 mcg capsule once daily (QD)
• Lubiprostone
12 mcg capsule twice daily (BID)
• Lubiprostone
24 mcg capsule twice daily (BID)

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	Children's Research Institute	Columbus	Ohio
United States	Pediatric Associates of Fairfield, Inc.	Fairfield	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	Jackson Clinic	Jackson	Tennessee
United States	Nemours Children's Clinic - Jacksonville	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Regional Gastroenterology Associates of Lancaster, Ltd.	Lancaster	Pennsylvania
United States	Arkansas Pediatric Clinic	Little Rock	Arkansas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	AHS Hospital Corporation	Morristown	New Jersey
United States	Children's Hospital and Research Center Oakland	Oakland	California
United States	The Center for Human Nutrition, Inc.	Omaha	Nebraska
United States	Center for Children's Digestive Health	Park Ridge	Illinois
United States	Nemours Children's Clinic - Pensacola	Pensacola	Florida
United States	University of Illinois at Peoria	Peoria	Illinois
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	University of Illinois at Chicago	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Spontaneous Bowel Movements	Gathered as part of the daily electronic diary questions.	Week 1
Secondary	Frequency of Spontaneous Bowel Movements	Gathered as part of the daily electronic diary questions.	Weeks 2, 3, and 4
Secondary	Frequency of Fecal Incontinence	As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.	Weekly, up to 4 weeks
Secondary	Straining Associated With SBMs	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
Secondary	Stool Consistency of SBMs	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
Secondary	Abdominal Bloating	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
Secondary	Abdominal Discomfort	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
Secondary	Pain Associated With SBMs	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
Secondary	Constipation Severity	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
Secondary	Treatment Effectiveness	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