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Completed

NCT Number: NCT00452335

Safety and Efficacy 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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lubiprostone

Drug

12 mcg capsule once daily (QD)

Other names: Amitiza®

Primary outcomes

  1. Frequency of Spontaneous Bowel Movements

    Time frame: Week 1

    Gathered as part of the daily electronic diary questions.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Sucampo Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2007
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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