Functional ConstipationPhase 3FCNCT01330381
Prucalopride in Pediatric Subjects With Functional Constipation
A Phase 3 study testing prucalopride and PEG 4000 in people with Functional Constipation, run by Shire at 1 site in Netherlands.
Trial summary
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- prucalopride and PEG 4000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Apr 2011to 1 Mar 2013
- 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 months to 17 years
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
- Boys and girls, aged ≥ 6 months and < 18 years.
- Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.
Main Exclusion Criteria:
- Children with underlying GI abnormalities and causes for defecation disorders.
- Constipation is thought to be drug-induced.
- Subjects suffering from secondary causes of chronic constipation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.
- Conditions
- Functional Constipation
- Being tested
- prucalopride, Placebo, PEG 4000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prucaloprideDrug
prucalopride
- subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
- subjects with weight >50 kg: prucalopride 2 mg tablet once daily
PlaceboDrug
Matching oral solution or oral tablets given once daily
PEG 4000Drug
| Study group | Role | What they receive |
|---|---|---|
| prucalopride | Experimental | drug Receives: Drug: prucalopride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PEG 4000 | Active comparator | 4-20g administered as an oral solution once daily Receives: Drug: PEG 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period
Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).
Measured: Last 4 weeks of double-blind treatment period
Secondary outcomes (18)
Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period
Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
Measured: Last 4 weeks of double-blind treatment period
Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period
Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).
Measured: Last 4 weeks of double-blind treatment period
Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period
Purposefully avoiding defecation.
Measured: Over the 8 week double blind treatment period
Painful Bowel Movements Score in the Double-Blind Treatment Period
Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.
Measured: Over the 8 week double blind treatment period
Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period
Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.
Measured: Over the 8 week double blind treatment period
Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period
Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.
Measured: Over the 8 week double blind treatment period
Large Diameter Stools in the Double-Blind Treatment Period
Large diameter stools make defecation more difficult. Small diameter stools are better.
Measured: Over the 8 week double blind treatment period
Abdominal Pain Score in Double-Blind Treatment Period
Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.
Measured: Over the 8 week double blind treatment period
Frequency of Toilet Training in the Double-Blind Treatment Period
Only for subjects after acquisition of toileting skills.
Measured: Over the 8 week double blind treatment period
Number of Rescue Medications Taken in the Double-Blind Treatment Period
Measured: Over the 8 week double blind treatment period
Time to First SBM in the Double-Blind Treatment Period
After intake of the trial medication on Day 1.
Measured: Day 1 onwards
Number of SBM Per Week in the Double-Blind Treatment Period
Measured: Over the 8 week double blind treatment period
Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period
Measured: Baseline and over the 8 week double blind treatment period
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period
Measured: 2 weeks
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period
Measured: 2 weeks
Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period
Measured: Over the 8 week double blind treatment period
Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
Measured: Over the 16 week open label treatment period
Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
Measured: Over the 16 week open label treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study start28 Apr 2011
- Primary completion1 Mar 2013
- Study completion1 Mar 2013
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 (2)Papers the sponsor has linked to this study.
- Other trials for Functional 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330381
- Sponsor's protocol ID
- SPD555-303
- Other IDs
- M0001-C303, 2010-022402-40
- Acronym
- FC
- Status last verified
- May 2021
- First submitted
- 4 Apr 2011
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mugie SM, Korczowski B, Bodi P, Green A, Kerstens R, Ausma J, Ruth M, Levine A, Benninga MA. Prucalopride is no more effective than placebo for children with functional constipation. Gastroenterology. 2014 Dec;147(6):1285-95.e1. doi: 10.1053/j.gastro.2014.09.005. Epub 2014 Sep 16.
PubMed 25239590van Schaick E, Benninga MA, Levine A, Magnusson M, Troy S. Development of a population pharmacokinetic model of prucalopride in children with functional constipation. Pharmacol Res Perspect. 2016 Jun 1;4(4):e00236. doi: 10.1002/prp2.236. eCollection 2016 Aug.
PubMed 27891230
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks
- ClinicalTrials.gov ID
- NCT01330381
- Acronym / sponsor ID
- FC / SPD555-303
- Conditions
- Functional Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 28 Apr 2011 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 26 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prucalopride | Experimental | Drug: prucalopridedrug |
| Placebo | Placebo comparator | Drug: Placebo |
| PEG 4000 | Active comparator | Drug: PEG 40004-20g administered as an oral solution once daily |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| prucaloprideprucalopride * subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml * subjects with weight >50 kg: prucalopride 2 mg tablet once daily | Drug | prucalopride |
| PlaceboMatching oral solution or oral tablets given once daily | Drug | Placebo |
| PEG 4000 | Drug | PEG 4000 |
Primary outcome
Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period
Time frame: Last 4 weeks of double-blind treatment period
Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).
18 secondary outcomes
Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period
Time frame: Last 4 weeks of double-blind treatment period
Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period
Time frame: Last 4 weeks of double-blind treatment period
Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Painful Bowel Movements Score in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Large Diameter Stools in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Abdominal Pain Score in Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Frequency of Toilet Training in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Number of Rescue Medications Taken in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Time to First SBM in the Double-Blind Treatment Period
Time frame: Day 1 onwards
Number of SBM Per Week in the Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period
Time frame: Baseline and over the 8 week double blind treatment period
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period
Time frame: 2 weeks
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period
Time frame: 2 weeks
Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period
Time frame: Over the 8 week double blind treatment period
Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
Time frame: Over the 16 week open label treatment period
Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
Time frame: Over the 16 week open label treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25239590Mugie SM, Korczowski B, Bodi P, Green A, Kerstens R, Ausma J, Ruth M, Levine A, Benninga MA. Prucalopride is no more effective than placebo for children with functional constipation. Gastroenterology. 2014 Dec;147(6):1285-95.e1. doi: 10.1053/j.gastro.2014.09.005. Epub 2014 Sep 16.
- Derived from this study: PubMed 27891230van Schaick E, Benninga MA, Levine A, Magnusson M, Troy S. Development of a population pharmacokinetic model of prucalopride in children with functional constipation. Pharmacol Res Perspect. 2016 Jun 1;4(4):e00236. doi: 10.1002/prp2.236. eCollection 2016 Aug.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prucalopride and PEG 4000 in people with Functional Constipation, run by Shire at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. Some participants in this study may receive a placebo. 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 26 Feb 2014). 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?
Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period (time frame: Last 4 weeks of double-blind treatment period). 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 NCT01330381, which also lists 2 linked publications.
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 10 Jun 2021.