Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00452335
NCT00452335CompletedPhase 4

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

Sucampo Pharma Americas, LLC19 sites in 1 country127 target enrollmentStarted: January 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
127
Locations
19
Primary Endpoint
Frequency of Spontaneous Bowel Movements
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Lubiprostone 12 mcg QD

Experimental

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

Intervention: Lubiprostone (Drug)

Lubiprostone 12 mcg BID

Experimental

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

Intervention: Lubiprostone (Drug)

Lubiprostone 24 mcg BID

Experimental

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

Intervention: Lubiprostone (Drug)

Outcomes

Primary Outcomes

Frequency of Spontaneous Bowel Movements

Time Frame: Week 1

Gathered as part of the daily electronic diary questions.

Secondary Outcomes

  • Frequency of Spontaneous Bowel Movements(Weeks 2, 3, and 4)
  • Constipation Severity(Weekly, up to 4 weeks)
  • Treatment Effectiveness(Weekly, up to 4 weeks)
  • Frequency of Fecal Incontinence(Weekly, up to 4 weeks)
  • Straining Associated With SBMs(Weekly, up to 4 weeks)
  • Stool Consistency of SBMs(Weekly, up to 4 weeks)
  • Abdominal Bloating(Weekly, up to 4 weeks)
  • Abdominal Discomfort(Weekly, up to 4 weeks)
  • Pain Associated With SBMs(Weekly, up to 4 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (19)

Loading locations...

Similar Trials

Completed
Phase 3
Opioid-induced Bowel Dysfunction Pivotal Assessment of LubiprostoneOpioid-Induced Bowel Dysfunction
NCT00597428Sucampo Pharma Americas, LLC437
Completed
Phase 3
Opioid-induced Bowel Dysfunction: Pivotal Assessment of LubiprostoneOpioid-Induced Bowel Dysfunction
NCT00595946Sucampo Pharma Americas, LLC439
Completed
Phase 3
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)Opioid-induced Bowel Dysfunction
NCT01298219Sucampo Pharma Americas, LLC439
Completed
Phase 4
Lubiprostone in Patients With Multiple Sclerosis Associated ConstipationMultiple SclerosisConstipation
NCT01236534University of Rochester21
Completed
Phase 3
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional ConstipationConstipation - Functional
NCT02766777Sucampo Pharma Americas, LLC87
Safety and Efficacy of Lubiprostone in... | Clinical Trial