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Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

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ClinicalTrials.gov Identifier: NCT00452335
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )

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.

Condition or disease Intervention/treatment Phase
Constipation Drug: Lubiprostone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation
Study Start Date : January 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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
Drug: Lubiprostone
12 mcg capsule once daily (QD)
Other Name: 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
Drug: Lubiprostone
12 mcg capsule twice daily (BID)
Other Name: 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
Drug: Lubiprostone
24 mcg capsule twice daily (BID)
Other Name: Amitiza®




Primary Outcome Measures :
  1. Frequency of Spontaneous Bowel Movements [ Time Frame: Week 1 ]
    Gathered as part of the daily electronic diary questions.


Secondary Outcome Measures :
  1. Frequency of Spontaneous Bowel Movements [ Time Frame: Weeks 2, 3, and 4 ]
    Gathered as part of the daily electronic diary questions.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452335


Locations
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United States, Arizona
Phoenix Children's Hospital
Pheonix, Arizona, United States, 85016
United States, Arkansas
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72005
United States, California
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
United States, Florida
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
United States, Illinois
Center for Children's Digestive Health
Park Ridge, Illinois, United States, 60068
University of Illinois at Peoria
Peoria, Illinois, United States, 61613
University of Illinois at Chicago
Springfield, Illinois, United States, 62708-0787
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Nebraska
The Center for Human Nutrition, Inc.
Omaha, Nebraska, United States, 68105
United States, New Jersey
AHS Hospital Corporation
Morristown, New Jersey, United States, 07962
United States, Ohio
Children's Research Institute
Columbus, Ohio, United States, 43205
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
Southeastern Clinical Research
Chattanooga, Tennessee, United States, 37403
Jackson Clinic
Jackson, Tennessee, United States, 38305
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Takeda
Investigators
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Principal Investigator: Paul Hyman, MD University of Kansas Medical Center

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Responsible Party: Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00452335     History of Changes
Other Study ID Numbers: 0211SC-0641
First Posted: March 27, 2007    Key Record Dates
Results First Posted: August 22, 2016
Last Update Posted: August 22, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action