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

Chronic Functional Constipation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751411
• Other study ID #: ABO-MELI-15
• Status: Completed
• Phase: Phase 4
• Start date: April 18, 2016
• Est. completion date: March 17, 2020

Study information

• Verified date: May 2020
• Source: Aboca Spa Societa' Agricola
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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-

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 17, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Chronic Functional Constipation
• Constipation

Intervention

Device:
• micro-enema with Promelaxin
The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.

Drug:
• Macrogol 4000
Stool softener

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Aboca Spa Societa' Agricola	Ceinge - Biotecnologie Avanzate s.c. a r.l., Eclisse - Euromed Clinical Supply Services Srl, Latis S.r.l., PhAST Consulting Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	score of the parents quality of life calculated on day 21 and 56	parents quality of life questionnaire	day 21 and day 56
Secondary	score of the children quality of life calculated on day 21 and 56	children quality of life questionnaire	day 21 and day 56
Secondary	Gastrointestinal symptoms in children on days 14, 21 and 56	gastrointestinal symptoms recording through/following treatment	day 14, day 21 and day 56
Secondary	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	day 21 and day 56
Secondary	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
Secondary	Product Safety	Adverse events reported by parents/legal representative of the subject	day 14, day 21 and day 56
Secondary	Change in stool consistency	Reduction of stool consistency with increase of 1 or more points on Bristol Stool Form Scale or Amsterdam scale	day 14, day 21 and day 56