Constipation - FunctionalPhase 3NCT02138136

Lubiprostone for Children With Constipation

A Phase 3 study testing Lubiprostone in people with Constipation - Functional, run by Sucampo Pharma Americas, LLC at 85 sites in 7 countries.

Completed

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

Official record

Search all trials

Trial summary

This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): were invited to participate will receive lubiprostone for 9 more months will see if lubiprostone safely relieves their constipation if taken for a whole year Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Constipation - Functional
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: 419 participants
Where: 85 sitesin 7 countries
Study dates: 26 Feb 2014to 1 May 2017
Phase: Phase 3
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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Has completed the 3-month placebo-controlled study (NCT02042183)
Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility

Who cannot join

Has untreated faecal impaction at the time of rolling over into study
Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)

Trial locations and contacts

85 sites in 7 countries.

Country

City, postcode or hospital

85 sites in 7 countries

United States67 sites

Children's Center for Digestive Health Care/GI Care for Kids
Atlanta, Georgia, 30342
PriMed Clinical Research
Beavercreek, Ohio, 45431
Pioneer Clinical Research
Bellevue, Nebraska, 68005
Northwest Clinicial Research Center
Bellevue, Washington, 98007
University of Vermont Medical Center
Burlington, Vermont, 05445
Coastal Pediatric Associates - James Island
Charleston, South Carolina, 29412
Coastal Clinical Research
Charleston, South Carolina, 29414
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
MCB Clinical Research
Colorado Springs, Colorado, 80910
Nationwide Children's Hospital
Columbus, Ohio, 43205
3rd Coast Research Associates
Corpus Christi, Texas, 78413
WCCT Global
Costa Mesa, California, 92626
Childrens Medical Center Dallas
Dallas, Texas, 75390
UnityPoint Health Des Moines/ Blank Children's Clinic
Des Moines, Iowa, 50309
Square-1 Clinical Research, Inc.
Erie, Pennsylvania, 16506
INOVA Pediatric Digestive Diseases Center
Fairfax, Virginia, 22031
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
Cook Children's Medical Center
Fort Worth, Texas, 76104
University of Florida
Gainesville, Florida, 32610
Greenville Health System
Greenville, South Carolina, 29615
Cyn3rgy Research
Gresham, Oregon, 97030
Palmetto Professional Research
Hialeah, Florida, 33016
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
The Jackson Clinic, P.C.
Jackson, Tennessee, 38305
Smart Medical Research, Inc.
Jackson Heights, New York, 11372
Nemours Children's Clinic
Jacksonville, Florida, 32207
The Children's Mercy Hospital
Kansas City, Missouri, 64145
Envision Clinical Research, LLC
Laredo, Texas, 78041
Arkansas Childrens Hospital Research Institute
Little Rock, Arkansas, 72202
Bridgerland Clinical Research
Logan, Utah, 84341
Loma Linda University Health Care
Loma Linda, California, 92350
DCOL Center for Clinical Research
Longview, Texas, 75605
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202
Acevedo Clinical Research Associates
Miami, Florida, 33142
Savin Medical Group Research Center
Miami Lakes, Florida, 33014
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of South Alabama Women's and Children's Hospital
Mobile, Alabama, 36604
Coastal Pediatrics Associates - Mount Pleasant
Mt. Pleasant, South Carolina, 29464
NY Presbyterian Weill Cornell
New York, New York, 10021
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, 10032
PediaResearch, LLC - Newburgh
Newburgh, Indiana, 47630
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
PediaResearch, LLC - Owensboro
Owensboro, Kentucky, 42301
Nemours Childrens Clinic
Pensacola, Florida, 32504
Methodist Medical Center
Peoria, Illinois, 61602
St. Christopher's Hospital for Children Drexel University
Philadelphia, Pennsylvania, 19134
Arizona Children's Center at Maricopa Medical Center
Phoenix, Arizona, 85008
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224
Zain Research LLC
Richland, Washington, 99352
Pediatric Gastroenterology Carilion Medical Center
Roanoke, Virginia, 24014
Primary Children's Medical Center
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
Willis-Knighton Physician Network
Shreveport, Louisiana, 71101
Virgo-Carter Pediatrics
Silver Spring, Maryland, 20910
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Wee Care Pediatrics
Syracuse, Utah, 84075
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, 98405
Toledo Children's Hospital
Toledo, Ohio, 43606
AAPRI Clinical Research
Warwick, Rhode Island, 02886
Emmerson Clinical Research
Washington D.C., District of Columbia, 20020
Heartland Research Associates
Wichita, Kansas, 67205
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803

Other trials in United States

Poland6 sites

Medical University of Bialystok
Bialystok, 15-274
Szpital Uniwersytecki
Bydgoszcz, 85-168
Szpital Pediatryczny ICZMP
Lodz, 93-338
Gabinet Lekarski Bartosc Korczowski
Rzeszów, 35-210
Przychodnia Specjalistyczna PROSEN
Warsaw, 01-231
Children's Memorial Health Institute
Warsaw, 04-730

Other trials in Poland

Netherlands4 sites

Emma Children's Hospital
Amsterdam, 1105 AZ
Amphia Ziekenhuis
Breda, 4800 RK
Maasstad Hospital Rotterdam
Rotterdam, 3079 DZ
Isala Klinieken
Zwolle, 8025 AB

Other trials in Netherlands

United Kingdom4 sites

Darlington Memorial Hospital
Darlington, DL3 6HZ
Royal London Hospital
London, E1 1BB
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Sheffield Children Hospital
Sheffield, S10 2TH

Other trials in United Kingdom

Belgium2 sites

Universitair Kinderziekenhuis Brussel
Brussels, 01090
CHC - Clinique Saint-Joseph
Montegnée, 04420

Other trials in Belgium

Canada1 site

Sainte Justine University Health Center
Montreal, H3T1C5

Other trials in Canada

France1 site

CHU-Bordeaux
Bordeaux, 33000

Other trials in France

About this study

Official title: A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

This study is for children with constipation.

Children who completed 3 months of treatment in the earlier study (NCT02042183):

were invited to participate
will receive lubiprostone for 9 more months
will see if lubiprostone safely relieves their constipation if taken for a whole year

Conditions: Constipation - Functional
Being tested: Lubiprostone

What participants receive

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

LubiprostoneDrug
Also called Amitiza®
12 or 24 mcg soft capsules for oral administration

Study groups in NCT02138136
Study group	Role	What they receive
Lubiprostone	Experimental	Participants receive lubiprostone twice daily Participants must have completed the entire 12-week treatment period during the preceding study. Those who received 12 mcg twice daily (BID) continued to receive 12 mcg, those who received 24 mcg BID continued with that dose.Those of the placebo arm in the previous study weighing less than 50 kg received 12 mcg BID and over 50 kg received 24 mcg BID during this study. Receives: Drug: Lubiprostone

What is being measured

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

Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
Measured: within 9 months

Timeline

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

26 Feb 20141 May 2017

First posted14 May 2014 (estimated)
Study start26 Feb 2014
Primary completion1 May 2017
Study completion1 May 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Constipation - FunctionalStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 419 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02138136
Sponsor's protocol ID: SAG-0211PFC-11S1
Other IDs: 2013-004384-31
Status last verified: Jan 2020
First submitted: 6 May 2014
Last updated: 21 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.
PubMed 33838349

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

Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
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)

All Constipation - Functional trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
ClinicalTrials.gov ID: NCT02138136
Acronym / sponsor ID: SAG-0211PFC-11S1
Conditions: Constipation - Functional
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 419 participants (actual)
Lead sponsor: Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
Collaborators: Takeda
Study start: 26 Feb 2014 (actual)
Primary completion: 1 May 2017 (actual)
Study completion: 1 May 2017 (actual)
First posted: 14 May 2014 (estimated)
Results: Posted 21 Jan 2020

Clinical summary

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

This study is for children with constipation.

Children who completed 3 months of treatment in the earlier study (NCT02042183):

were invited to participate
will receive lubiprostone for 9 more months
will see if lubiprostone safely relieves their constipation if taken for a whole year

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lubiprostone	Experimental	Drug: LubiprostoneParticipants receive lubiprostone twice daily Participants must have completed the entire 12-week treatment period during the preceding study. Those who received 12 mcg twice daily (BID) continued to receive 12 mcg, those who received 24 mcg BID continued with that dose.Those of the placebo arm in the previous study weighing less than 50 kg received 12 mcg BID and over 50 kg received 24 mcg BID during this study.

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Has completed the 3-month placebo-controlled study (NCT02042183)
Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility

Key exclusion criteria (3 listed)

Has untreated faecal impaction at the time of rolling over into study
Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)

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 or 24 mcg soft capsules for oral administration	Drug	Lubiprostone

Primary outcome

Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
Time frame: within 9 months
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.

Results and safety

Results posted to the registry on 21 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	419	280

Primary outcome: Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month

Time frame: within 9 months. Median (Full Range). Unit: Weekly SBMs

Measure	All Participants n = 418
Month 1	2.66 (0.00 to 15.00)
Month 2	2.75 (0.00 to 14.73)
Month 3	2.70 (0.00 to 18.38)
Month 4	2.75 (0.00 to 12.83)
Month 5	2.74 (0.00 to 14.00)
Month 6	2.50 (0.00 to 7.75)
Month 7	2.63 (0.00 to 12.11)
Month 8	2.63 (0.00 to 11.00)

Population analysed: mITT with evaluable data at the given time point

Adverse events

Time frame: from first open-label dose to last open-label dose plus 7 days (9 months, 7 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	13 of 419 (3.1%)	147 of 419 (35.1%)	0 of 419

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33838349Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.
Individual participant dataSharing planned: No

Related trials for Constipation - Functional

Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
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)

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.

Global Clinical Leader study director

Mallinckrodt

85 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lubiprostone in people with Constipation - Functional, run by Sucampo Pharma Americas, LLC at 85 sites in 7 countries.

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 2 inclusion and 3 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Poland, Netherlands, United Kingdom, Belgium and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Jan 2020). 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?

Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month (time frame: within 9 months). 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 NCT02138136, which also lists 1 linked publication.

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 21 Jan 2020.