Chronic Functional ConstipationPhase 4NCT02751411
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
A Phase 4 study testing micro-enema with Promelaxin and Macrogol 4000 in people with Chronic Functional Constipation, run by Aboca Spa Societa' Agricola at 4 sites in Italy.
Trial summary
The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up- Read more about this study
- Who is it for?
- Ages 6 to 48 months
- Conditions the study is for
- Chronic Functional Constipation
- What is being tested?
- micro-enema with Promelaxin and Macrogol 4000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 4 sitesItaly
- Study dates
- 18 Apr 2016to 17 Mar 2020
- 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 6 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronic functional constipation according to Rome III criteria
- No stool softeners therapy administered during the 7 days prior to Baseline Visit
- Signature of informed consent from by both parents or legal representative
- Willingness to follow the study schedule
Who cannot join
- Suspicious or established diagnosis of organic constipation
- Delayed emission of meconium in the term newborn
- Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
- Presence/Risk of gastroinstestinal perforation
- Presence/Suspiceous intestinal obstruction of symptomatic stenosis
- (Undeterminated) Abdominal pain
Show all 10Show fewer
- Hypersensitivity to macrogol (polyethylene glycol) or to one or more product excipients
- Hereditary fructose intolerance
- Known hypersensitivity or allergy to any Promelaxin component
- Presence of any other medical condition that contraindicate the use of Promelaxin® or Macrogol 4000
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
L’Aquila, AQ, 67100
Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
Naples, 80131
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Naples, 80138
Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19
Pavia, PV, 27100
About this study
Official title: Multicenter, Prospective, Comparative, Randomized Controlled Clinical Trial to Evaluate the Performance and the Safety of Promelaxin® Micro-enemas Vs. Macrogol 4000 Per os in the Treatment of Functional Chronic Constipation in Children Aged Between 6 and 48 Months.
The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-
Read the detailed description
This multicenter, prospective, randomized, controlled trial will be conducted on 120 infants-children with a diagnosis of chronic functional constipation according to the definition of Criteria of Rome III. The enrolled subjects will be randomized according to an electronically generated randomization list in 2 groups: one group will receive micro-enemas of Promelaxin® (Group A) while the second group will receive Macrogol 4000 per os (Group B) . Children will receive the dedicated treatment for two weeks and then undergo a follow-up period of a maximun of 6 weeks.
The hypothesis is that the protective micro-enema will help achieving regular evacuation by its local antinflammatory non-pharmacological action. This hypothesis is based on the finding that local anal inflammation can cause functional constipation due to discomfort and pain during evacuation or by influencing reflexes.
- Conditions
- Chronic Functional Constipation
- Being tested
- micro-enema with Promelaxin, Macrogol 4000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-enema with PromelaxinDevice
Also called Melilax
The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.
Macrogol 4000Drug
Also called Paxabel
Stool softener
| Study group | Role | What they receive |
|---|---|---|
| micro-enema with Promelaxin | Experimental | 2,5 g, 5 g or 2X5 g (calculated considering patient age) have to be administered daily (in the evening) for one week, once every other day for the second week and as needed for the following 6 weeks Receives: Device: micro-enema with Promelaxin |
| Macrogol 4000 | Active comparator | One/Two sachets of the study treatment has to be solubilized in 50mL of water and then administered daily. The administration should take place in the morning (the first sachet or in the event that only one sachet/day should be administered) and in the evening (second sachet). Receives: Drug: Macrogol 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation
Treatment should be considered as successful if the child will show, at Visit 3, 3 or more defecations per week associated with an increase of 1 or more defecations versus baseline.
Measured: day 14
Secondary outcomes (7)
score of the parents quality of life calculated on day 21 and 56
parents quality of life questionnaire
Measured: day 21 and day 56
score of the children quality of life calculated on day 21 and 56
children quality of life questionnaire
Measured: day 21 and day 56
Gastrointestinal symptoms in children on days 14, 21 and 56
gastrointestinal symptoms recording through/following treatment
Measured: day 14, day 21 and day 56
changes in the intestinal microbioma on day 21 and 56
the intestinal microbioma will be analysed in laboratory to see whether a treatment influence can be measured
Measured: day 21 and day 56
Evaluation of the normalization of intestinal activity measured by recording frequency of evacuations and stool consistency on day 14, 21 and 56
Measured: day 14, day 21 and day 56
Product Safety
Adverse events reported by parents/legal representative of the subject
Measured: day 14, day 21 and day 56
Change in stool consistency
Reduction of stool consistency with increase of 1 or more points on Bristol Stool Form Scale or Amsterdam scale
Measured: day 14, day 21 and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start18 Apr 2016
- Primary completion31 Dec 2019
- Study completion17 Mar 2020
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 Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized between two treatment arms
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eclisse - Euromed Clinical Supply Services Srl, Ceinge - Biotecnologie Avanzate s.c. a r.l., Latis S.r.l., PhAST Consulting Srl
- Responsible party
- Sponsor
- Investigators
- Annamaria Staiano, Prof., Principal investigator, Universita Federico II - Pediatric Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751411
- Sponsor's protocol ID
- ABO-MELI-15
- Status last verified
- May 2020
- First submitted
- 22 Apr 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strisciuglio C, Coppola V, Russo M, Tolone C, Marseglia GL, Verrotti A, Caimmi S, Caloisi C, D'Argenio V, Sacchetti L, Staiano A. Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial. Front Pediatr. 2021 Oct 29;9:753938. doi: 10.3389/fped.2021.753938. eCollection 2021.
PubMed 34778144
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Comparative, Randomized Controlled Clinical Trial to Evaluate the Performance and the Safety of Promelaxin® Micro-enemas Vs. Macrogol 4000 Per os in the Treatment of Functional Chronic Constipation in Children Aged Between 6 and 48 Months.
- ClinicalTrials.gov ID
- NCT02751411
- Acronym / sponsor ID
- ABO-MELI-15
- Conditions
- Chronic Functional Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- Eclisse - Euromed Clinical Supply Services Srl, Ceinge - Biotecnologie Avanzate s.c. a r.l., Latis S.r.l., PhAST Consulting Srl
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 26 Apr 2016 (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 study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-
Detailed description
This multicenter, prospective, randomized, controlled trial will be conducted on 120 infants-children with a diagnosis of chronic functional constipation according to the definition of Criteria of Rome III. The enrolled subjects will be randomized according to an electronically generated randomization list in 2 groups: one group will receive micro-enemas of Promelaxin® (Group A) while the second group will receive Macrogol 4000 per os (Group B) . Children will receive the dedicated treatment for two weeks and then undergo a follow-up period of a maximun of 6 weeks.
The hypothesis is that the protective micro-enema will help achieving regular evacuation by its local antinflammatory non-pharmacological action. This hypothesis is based on the finding that local anal inflammation can cause functional constipation due to discomfort and pain during evacuation or by influencing reflexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized between two treatment arms
| Arm | Type | Receives |
|---|---|---|
| micro-enema with Promelaxin | Experimental | Device: micro-enema with Promelaxin2,5 g, 5 g or 2X5 g (calculated considering patient age) have to be administered daily (in the evening) for one week, once every other day for the second week and as needed for the following 6 weeks |
| Macrogol 4000 | Active comparator | Drug: Macrogol 4000One/Two sachets of the study treatment has to be solubilized in 50mL of water and then administered daily. The administration should take place in the morning (the first sachet or in the event that only one sachet/day should be administered) and in the evening (second sachet). |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Chronic functional constipation according to Rome III criteria
- No stool softeners therapy administered during the 7 days prior to Baseline Visit
- Signature of informed consent from by both parents or legal representative
- Willingness to follow the study schedule
Key exclusion criteria (10 listed)
- Suspicious or established diagnosis of organic constipation
- Delayed emission of meconium in the term newborn
- Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
- Presence/Risk of gastroinstestinal perforation
- Presence/Suspiceous intestinal obstruction of symptomatic 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 |
|---|---|---|
| micro-enema with PromelaxinAlso: MelilaxThe intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex. | Device | micro-enema with Promelaxin |
| Macrogol 4000Also: PaxabelStool softener | Drug | Macrogol 4000 |
Primary outcome
Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation
Time frame: day 14
Treatment should be considered as successful if the child will show, at Visit 3, 3 or more defecations per week associated with an increase of 1 or more defecations versus baseline.
7 secondary outcomes
score of the parents quality of life calculated on day 21 and 56
Time frame: day 21 and day 56
score of the children quality of life calculated on day 21 and 56
Time frame: day 21 and day 56
Gastrointestinal symptoms in children on days 14, 21 and 56
Time frame: day 14, day 21 and day 56
changes in the intestinal microbioma on day 21 and 56
Time frame: day 21 and day 56
Evaluation of the normalization of intestinal activity measured by recording frequency of evacuations and stool consistency on day 14, 21 and 56
Time frame: day 14, day 21 and day 56
Product Safety
Time frame: day 14, day 21 and day 56
Change in stool consistency
Time frame: day 14, day 21 and day 56
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 29 May 2020.
- Derived from this study: PubMed 34778144Strisciuglio C, Coppola V, Russo M, Tolone C, Marseglia GL, Verrotti A, Caimmi S, Caloisi C, D'Argenio V, Sacchetti L, Staiano A. Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial. Front Pediatr. 2021 Oct 29;9:753938. doi: 10.3389/fped.2021.753938. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Annamaria Staiano, Prof. principal investigator
Universita Federico II - Pediatric Department
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing micro-enema with Promelaxin and Macrogol 4000 in people with Chronic Functional Constipation, run by Aboca Spa Societa' Agricola at 4 sites in Italy.
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 10 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 29 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 4 sites in Italy. 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 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?
Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation (time frame: day 14). 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 NCT02751411, 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 29 May 2020.