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Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Lubiprostone
Lubiprostone
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children's Hospital
  • Arkansas Pediatric Clinic
  • Children's Hospital and Research Center Oakland
  • Nemours Children's Clinic - Jacksonville
  • Nemours Children's Clinic - Pensacola
  • Center for Children's Digestive Health
  • University of Illinois at Peoria
  • University of Illinois at Chicago
  • Indiana University
  • University of Kansas Medical Center
  • Children's Hospital Boston
  • The Center for Human Nutrition, Inc.
  • AHS Hospital Corporation
  • Children's Research Institute
  • Pediatric Associates of Fairfield, Inc.
  • Regional Gastroenterology Associates of Lancaster, Ltd.
  • Southeastern Clinical Research
  • Jackson Clinic
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lubiprostone 12 mcg QD

Lubiprostone 12 mcg BID

Lubiprostone 24 mcg BID

Arm Description

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

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

Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Outcomes

Primary Outcome Measures

Frequency of Spontaneous Bowel Movements
Gathered as part of the daily electronic diary questions.

Secondary Outcome Measures

Frequency of Spontaneous Bowel Movements
Gathered as part of the daily electronic diary questions.
Frequency of Fecal Incontinence
As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.
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.
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.
Abdominal Bloating
Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Abdominal Discomfort
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
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.
Constipation Severity
Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
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.

Full Information

First Posted
March 26, 2007
Last Updated
December 13, 2019
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00452335
Brief Title
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Official Title
A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone 12 mcg QD
Arm Type
Experimental
Arm Description
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
Arm Title
Lubiprostone 12 mcg BID
Arm Type
Experimental
Arm Description
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
Arm Title
Lubiprostone 24 mcg BID
Arm Type
Experimental
Arm Description
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza®
Intervention Description
12 mcg capsule once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza®
Intervention Description
12 mcg capsule twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza®
Intervention Description
24 mcg capsule twice daily (BID)
Primary Outcome Measure Information:
Title
Frequency of Spontaneous Bowel Movements
Description
Gathered as part of the daily electronic diary questions.
Time Frame
Week 1
Secondary Outcome Measure Information:
Title
Frequency of Spontaneous Bowel Movements
Description
Gathered as part of the daily electronic diary questions.
Time Frame
Weeks 2, 3, and 4
Title
Frequency of Fecal Incontinence
Description
As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.
Time Frame
Weekly, up to 4 weeks
Title
Straining Associated With SBMs
Description
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.
Time Frame
Weekly, up to 4 weeks
Title
Stool Consistency of SBMs
Description
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.
Time Frame
Weekly, up to 4 weeks
Title
Abdominal Bloating
Description
Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time Frame
Weekly, up to 4 weeks
Title
Abdominal Discomfort
Description
Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time Frame
Weekly, up to 4 weeks
Title
Pain Associated With SBMs
Description
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.
Time Frame
Weekly, up to 4 weeks
Title
Constipation Severity
Description
Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time Frame
Weekly, up to 4 weeks
Title
Treatment Effectiveness
Description
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.
Time Frame
Weekly, up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Hyman, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arkansas Pediatric Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72005
Country
United States
Facility Name
Children's Hospital and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Nemours Children's Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Nemours Children's Clinic - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Center for Children's Digestive Health
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
University of Illinois at Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61613
Country
United States
Facility Name
University of Illinois at Chicago
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62708-0787
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
The Center for Human Nutrition, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
AHS Hospital Corporation
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Children's Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Pediatric Associates of Fairfield, Inc.
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Regional Gastroenterology Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Southeastern Clinical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

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