ConstipationPhase 1NCT01670669
Prucalopride in Paediatric Subjects, With Functional Faecal Retention
A Phase 1 study testing prucalopride in people with Constipation, run by Movetis.
Trial summary
The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Constipation
- What is being tested?
- prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Jul 1999
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 4 to 12 years
- Child
Who may be able to join
- Subject completed the PRU-USA-12 pharmacokinetic trial
- Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)
- Written informed consent, signed by the subject's legal guardian and by the investigator
- Subject assent documented in the form of a note-to-file in the subject's source documentation
Who cannot join
- No exclusion criteria
About this study
Official title: An Open-label Follow-up Study of 0.01 mg/kg/Day to 0.03 mg/kg/Day Prucalopride (R108512) Oral Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR), Who Participated in the PRU-USA-12.
The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.
Hypothesis:
Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.
Read the detailed description
This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial, usually within the previous week.
Evaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.
The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day.
- Conditions
- Constipation
- Being tested
- prucalopride
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prucaloprideDrug
0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution
| Study group | Role | What they receive |
|---|---|---|
| prucalopride | Active comparator | 0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution Receives: Drug: prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated.
Efficacy: reporting of bowel movements and its characteristics in a diary.
Efficacy
Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.
Secondary outcomes (1)
Secondary efficacy variables: steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startNov 1998
- Primary completionJul 1999
- Study completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harald Winter, M.D., Principal investigator, Massachusetts General Hospital for Children, Boston, Massachusetts, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670669
- Sponsor's protocol ID
- PRU-USA-24
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
Publications
Winter HS, Di Lorenzo C, Benninga MA, Gilger MA, Kearns GL, Hyman PE, Vandeplassche L, Ausma J, Hoppenbrouwers M. Oral prucalopride in children with functional constipation. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):197-203. doi: 10.1097/MPG.0b013e318292f9ea.
PubMed 23535761
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Follow-up Study of 0.01 mg/kg/Day to 0.03 mg/kg/Day Prucalopride (R108512) Oral Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR), Who Participated in the PRU-USA-12.
- ClinicalTrials.gov ID
- NCT01670669
- Acronym / sponsor ID
- PRU-USA-24
- Conditions
- Constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Jul 1999 (actual)
- Study completion
- Jul 1999 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.
Hypothesis:
Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.
Detailed description
This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial, usually within the previous week.
Evaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.
The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prucalopride | Active comparator | Drug: prucalopride0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution |
Who may qualify
- Ages
- 4 to 12 years
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject completed the PRU-USA-12 pharmacokinetic trial
- Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)
- Written informed consent, signed by the subject's legal guardian and by the investigator
- Subject assent documented in the form of a note-to-file in the subject's source documentation
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| prucalopride0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution | Drug | prucalopride |
Primary outcome
Adverse events
Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated. Efficacy: reporting of bowel movements and its characteristics in a diary.
Efficacy
Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.
1 secondary outcome
Secondary efficacy variables: steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
- Derived from this study: PubMed 23535761Winter HS, Di Lorenzo C, Benninga MA, Gilger MA, Kearns GL, Hyman PE, Vandeplassche L, Ausma J, Hoppenbrouwers M. Oral prucalopride in children with functional constipation. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):197-203. doi: 10.1097/MPG.0b013e318292f9ea.
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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.
Harald Winter, M.D. principal investigator
Massachusetts General Hospital for Children, Boston, Massachusetts, USA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing prucalopride in people with Constipation, run by Movetis.
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 4 inclusion and 1 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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events. The study lists 2 primary outcomes in all. 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 NCT01670669, 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 22 Aug 2012.