ConstipationPhase 4NCT00452335

Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

A Phase 4 study testing Lubiprostone in people with Constipation, run by Sucampo Pharma Americas, LLC at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Constipation
What is being tested?: Lubiprostone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 19 sitesUnited States
Study dates: Jan 2007to Oct 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

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

Other trials in United States

About this study

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

Conditions: Constipation
Being tested: Lubiprostone
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LubiprostoneDrug
Also called Amitiza®
12 mcg capsule once daily (QD)
LubiprostoneDrug
Also called Amitiza®
12 mcg capsule twice daily (BID)
LubiprostoneDrug
Also called Amitiza®
24 mcg capsule twice daily (BID)

Study groups in NCT00452335
Study group	Role	What they receive
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 Receives: Drug: Lubiprostone
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 Receives: Drug: Lubiprostone
Lubiprostone 24 mcg BID	Experimental	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight Receives: Drug: Lubiprostone

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Spontaneous Bowel Movements
Gathered as part of the daily electronic diary questions.
Measured: Week 1

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Oct 2008

First posted27 Mar 2007 (estimated)
Study startJan 2007
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00452335
Sponsor's protocol ID: 0211SC-0641
Status last verified: Jul 2016
First submitted: 26 Mar 2007
Last updated: 17 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation
ClinicalTrials.gov ID: NCT00452335
Acronym / sponsor ID: 0211SC-0641
Conditions: Constipation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
Collaborators: Sucampo Pharmaceuticals, Inc.
Study start: Jan 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 27 Mar 2007 (estimated)
Results: Posted 22 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Lubiprostone 12 mcg QD	Experimental	Drug: LubiprostoneChildren (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
Lubiprostone 12 mcg BID	Experimental	Drug: LubiprostoneUp 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
Lubiprostone 24 mcg BID	Experimental	Drug: LubiprostoneAdolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LubiprostoneAlso: Amitiza®12 mcg capsule once daily (QD)	Drug	Lubiprostone 12 mcg QD
LubiprostoneAlso: Amitiza®12 mcg capsule twice daily (BID)	Drug	Lubiprostone 12 mcg BID
LubiprostoneAlso: Amitiza®24 mcg capsule twice daily (BID)	Drug	Lubiprostone 24 mcg BID

Primary outcome

Frequency of Spontaneous Bowel Movements
Time frame: Week 1
Gathered as part of the daily electronic diary questions.

9 secondary outcomes

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

Results and safety

Results posted to the registry on 22 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
12 mcg QD	27	25
12 mcg BID	65	61
24 mcg BID	32	23

Primary outcome: Frequency of Spontaneous Bowel Movements

Time frame: Week 1. Mean (Standard Deviation). Unit: spontaneous bowel movements per week

Measure	12 mcg QD n = 27	12 mcg BID n = 65	24 mcg BID n = 31
Value	2.47 (2.68)	3.02 (2.17)	3.84 (2.51)

Population analysed: ITT population

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent AEs: up to 4 weeks plus 7 days (from time of first dose to 7 days post-treatment). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
12 mcg QD	0 of 27 (0%)	5 of 27 (18.5%)	Not reported
12 mcg BID	1 of 65 (1.5%)	23 of 65 (35.4%)	Not reported
24 mcg BID	0 of 32 (0%)	14 of 32 (43.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Hyman, MD principal investigator

University of Kansas Medical Center

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lubiprostone in people with Constipation, run by Sucampo Pharma Americas, LLC at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Spontaneous Bowel Movements (time frame: Week 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00452335.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.