ConstipationPhase 4NCT01592734
Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
A Phase 4 study testing Polyethylene glycol with electrolytes and Polyethylene glycol in people with Constipation and Faecal Impaction, run by Azienda Policlinico Umberto I.
Trial summary
The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Constipation, Faecal Impaction
- What is being tested?
- Polyethylene glycol with electrolytes and Polyethylene glycol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Nov 2011
- Phase
- Phase 4
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination
Who cannot join
- children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities;
- Children receiving medication influencing gastrointestinal motility;
- Children with suspected gastrointestinal obstruction or stenosis
About this study
Official title: Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children. A Controlled Double Blind Randomized Study vs a Standard PEG-EL Laxative
The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation
Read the detailed description
Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation.
Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools.
It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.
- Conditions
- Constipation, Faecal Impaction
- Being tested
- Polyethylene glycol with electrolytes, Polyethylene glycol
- Keywords
- chronic constipation, faecal impaction, PEG-only laxative
- Medical subject headings
- Constipation, Fecal Impaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol with electrolytesDrug
Also called Movicol bambini
Constipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks.
Faecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days.
Polyethylene glycolDevice
Also called Onligol
Constipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children > 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks.
Faecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days.
| Study group | Role | What they receive |
|---|---|---|
| PEG-only | Experimental | Polyethylene glycol 4000 only (PEG-only). Receives: Device: Polyethylene glycol |
| PEG-EL | Active comparator | Polyethylene glycol 3350 with electrolytes (PEG-EL). Receives: Drug: Polyethylene glycol with electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card
Measured: 4 weeks of observation
Efficacy
Feacal impaction resolution
Measured: 7 days
Secondary outcomes (4)
Clinical tolerability
Recording of all Adverse Events (AEs) occurred during the study
Measured: 4 weeks of observation
Acceptability
Palatability and easy of taking the solution evaluated by a 5-points scale
Measured: 4 weeks of observation
Compliance
Percentage of patients who took more than 80% of the prescribed dose
Measured: 4 weeks
Efficacy
Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Responsible party
- Principal investigator, Giovanni Di Nardo, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592734
- Sponsor's protocol ID
- PEG-P1
- Status last verified
- May 2012
- First submitted
- 4 May 2012
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.
PubMed 23152962
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children. A Controlled Double Blind Randomized Study vs a Standard PEG-EL Laxative
- ClinicalTrials.gov ID
- NCT01592734
- Acronym / sponsor ID
- PEG-P1
- Conditions
- Constipation, Faecal Impaction
- Keywords
- chronic constipation, faecal impaction, PEG-only laxative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 May 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 aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation
Detailed description
Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation.
Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools.
It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-only | Experimental | Device: Polyethylene glycolPolyethylene glycol 4000 only (PEG-only). |
| PEG-EL | Active comparator | Drug: Polyethylene glycol with electrolytesPolyethylene glycol 3350 with electrolytes (PEG-EL). |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination
Key exclusion criteria (3 listed)
- children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities;
- Children receiving medication influencing gastrointestinal motility;
- Children with suspected gastrointestinal obstruction or stenosis
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 |
|---|---|---|
| Polyethylene glycol with electrolytesAlso: Movicol bambiniConstipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks. Faecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days. | Drug | PEG-EL |
| Polyethylene glycolAlso: OnligolConstipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children > 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks. Faecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days. | Device | PEG-only |
Primary outcome
Efficacy
Time frame: 4 weeks of observation
Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card
Efficacy
Time frame: 7 days
Feacal impaction resolution
4 secondary outcomes
Clinical tolerability
Time frame: 4 weeks of observation
Acceptability
Time frame: 4 weeks of observation
Compliance
Time frame: 4 weeks
Efficacy
Time frame: 4 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 7 May 2012.
- Derived from this study: PubMed 23152962Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene glycol with electrolytes and Polyethylene glycol in people with Constipation and Faecal Impaction, run by Azienda Policlinico Umberto I.
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 1 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 7 May 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 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?
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?
Efficacy (time frame: 4 weeks of observation). 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 NCT01592734, 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 7 May 2012.