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Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

Primary Purpose

Chronic Functional Constipation

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
micro-enema with Promelaxin
Macrogol 4000
Sponsored by
Aboca Spa Societa' Agricola
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Functional Constipation

Eligibility Criteria

6 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
  • Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19
  • Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
  • AOU Università degli Studi della Campania "Luigi Vanvitelli"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

micro-enema with Promelaxin

Macrogol 4000

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

score of the parents quality of life calculated on day 21 and 56
parents quality of life questionnaire
score of the children quality of life calculated on day 21 and 56
children quality of life questionnaire
Gastrointestinal symptoms in children on days 14, 21 and 56
gastrointestinal symptoms recording through/following treatment
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
Evaluation of the normalization of intestinal activity measured by recording frequency of evacuations and stool consistency on day 14, 21 and 56
Product Safety
Adverse events reported by parents/legal representative of the subject
Change in stool consistency
Reduction of stool consistency with increase of 1 or more points on Bristol Stool Form Scale or Amsterdam scale

Full Information

First Posted
April 22, 2016
Last Updated
May 28, 2020
Sponsor
Aboca Spa Societa' Agricola
Collaborators
Eclisse - Euromed Clinical Supply Services Srl, Ceinge - Biotecnologie Avanzate s.c. a r.l., Latis S.r.l., PhAST Consulting Srl
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1. Study Identification

Unique Protocol Identification Number
NCT02751411
Brief Title
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aboca Spa Societa' Agricola
Collaborators
Eclisse - Euromed Clinical Supply Services Srl, Ceinge - Biotecnologie Avanzate s.c. a r.l., Latis S.r.l., PhAST Consulting Srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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-
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Functional Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized between two treatment arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
micro-enema with Promelaxin
Arm Type
Experimental
Arm Description
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
Arm Title
Macrogol 4000
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
micro-enema with Promelaxin
Other Intervention Name(s)
Melilax
Intervention Description
The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.
Intervention Type
Drug
Intervention Name(s)
Macrogol 4000
Other Intervention Name(s)
Paxabel
Intervention Description
Stool softener
Primary Outcome Measure Information:
Title
Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation
Description
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.
Time Frame
day 14
Secondary Outcome Measure Information:
Title
score of the parents quality of life calculated on day 21 and 56
Description
parents quality of life questionnaire
Time Frame
day 21 and day 56
Title
score of the children quality of life calculated on day 21 and 56
Description
children quality of life questionnaire
Time Frame
day 21 and day 56
Title
Gastrointestinal symptoms in children on days 14, 21 and 56
Description
gastrointestinal symptoms recording through/following treatment
Time Frame
day 14, day 21 and day 56
Title
changes in the intestinal microbioma on day 21 and 56
Description
the intestinal microbioma will be analysed in laboratory to see whether a treatment influence can be measured
Time Frame
day 21 and day 56
Title
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
Title
Product Safety
Description
Adverse events reported by parents/legal representative of the subject
Time Frame
day 14, day 21 and day 56
Title
Change in stool consistency
Description
Reduction of stool consistency with increase of 1 or more points on Bristol Stool Form Scale or Amsterdam scale
Time Frame
day 14, day 21 and day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annamaria Staiano, Prof.
Organizational Affiliation
Universita Federico II - Pediatric Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
City
L'Aquila
State/Province
AQ
ZIP/Postal Code
67100
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU Università degli Studi della Campania "Luigi Vanvitelli"
City
Napoli
ZIP/Postal Code
80138
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34778144
Citation
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.
Results Reference
derived

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Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

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