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

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:
  • Amitiza®
12 mcg capsule twice daily (BID)
Other Names:
  • Amitiza®
24 mcg capsule twice daily (BID)
Other Names:
  • Amitiza®
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:
  • Amitiza®
12 mcg capsule twice daily (BID)
Other Names:
  • Amitiza®
24 mcg capsule twice daily (BID)
Other Names:
  • Amitiza®
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:
  • Amitiza®
12 mcg capsule twice daily (BID)
Other Names:
  • Amitiza®
24 mcg capsule twice daily (BID)
Other Names:
  • Amitiza®

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.

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

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.

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