Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
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.
1 other identifier
interventional
158
1 country
4
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-
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2016
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2016
CompletedFirst Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2020
CompletedMay 29, 2020
May 1, 2020
3.7 years
April 22, 2016
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
day 14
Secondary Outcomes (7)
score of the parents quality of life calculated on day 21 and 56
day 21 and day 56
score of the children quality of life calculated on day 21 and 56
day 21 and day 56
Gastrointestinal symptoms in children on days 14, 21 and 56
day 14, day 21 and day 56
changes in the intestinal microbioma on day 21 and 56
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
day 14, day 21 and day 56
- +2 more secondary outcomes
Study Arms (2)
micro-enema with Promelaxin
EXPERIMENTAL2,5 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 COMPARATOROne/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).
Interventions
The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aboca Spa Societa' Agricolalead
- Eclisse - Euromed Clinical Supply Services Srlcollaborator
- Ceinge - Biotecnologie Avanzate s.c. a r.l.collaborator
- Latis S.r.l.collaborator
- PhAST Consulting Srlcollaborator
Study Sites (4)
ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
L’Aquila, AQ, 67100, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19
Pavia, PV, 27100, Italy
Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
Napoli, 80131, Italy
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, 80138, Italy
Related Publications (1)
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.
PMID: 34778144DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annamaria Staiano, Prof.
Universita Federico II - Pediatric Department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 26, 2016
Study Start
April 18, 2016
Primary Completion
December 31, 2019
Study Completion
March 17, 2020
Last Updated
May 29, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share