Constipation - FunctionalPhase 3NCT02766777
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
A Phase 3 study testing Lubiprostone in people with Constipation - Functional, run by Sucampo Pharma Americas, LLC at 13 sites in United States.
Trial summary
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation. 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
- 87 participants
- Where
- 13 sitesUnited States
- Study dates
- 12 Apr 2016to 4 Nov 2016
- 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
- Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
- At least 6 years of age but less than 18 years of age at the time of randomisation
- Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants
Who cannot join
- Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
- Untreated faecal impaction at the time of screening
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
PriMed Clinical Research
Beavercreek, Ohio, 45431
Pioneer Clinical Research
Bellevue, Nebraska, 68005
Coastal Clinical Research
Charleston, South Carolina, 29414
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
3rd Coast Research Associates
Corpus Christi, Texas, 78413
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
Cyn3rgy Research
Gresham, Oregon, 97030
Bridgerland Clinical Research
Logan, Utah, 84341
Coastal Pediatrics Associates - Mount Pleasant
Mt. Pleasant, South Carolina, 29464
Methodist Medical Center
Peoria, Illinois, 61602
Willis-Knighton Physician Network
Shreveport, Louisiana, 71101
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Wee Care Pediatrics
Syracuse, Utah, 84075
About this study
Official title: A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.
Read the detailed description
To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.
- 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 group | Role | What they receive |
|---|---|---|
| Lubiprostone | Experimental | Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks. Receives: Drug: Lubiprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.
Measured: within 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start12 Apr 2016
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
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 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sucampo AG
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766777
- Sponsor's protocol ID
- SCMP-0211-303
- Status last verified
- May 2020
- First submitted
- 6 May 2016
- Last updated
- 15 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
- ClinicalTrials.gov ID
- NCT02766777
- Acronym / sponsor ID
- SCMP-0211-303
- Conditions
- Constipation - Functional
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Sucampo AG
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 15 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.
Detailed description
To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.
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 received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
- At least 6 years of age but less than 18 years of age at the time of randomisation
- Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants
Key exclusion criteria (3 listed)
- Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
- Untreated faecal impaction at the time of screening
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
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: Amitiza12 or 24 mcg soft capsules for oral administration. | Drug | Lubiprostone |
Primary outcome
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: within 25 weeks
Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Constipation - Functional
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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 recruitingPhase 3
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RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
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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.
Clinical Team Leader study director
Mallinckrodt
13 sites in 1 country: 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 13 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 3 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 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 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 15 May 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?
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) (time frame: within 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2020.