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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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ClinicalTrials.gov Identifier: NCT02751411
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Eclisse - Euromed Clinical Supply Services Srl
Ceinge - Biotecnologie Avanzate s.c. a r.l.
Latis S.r.l.
PhAST Consulting Srl
Information provided by (Responsible Party):
Aboca Spa Societa' Agricola

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-

Condition or disease Intervention/treatment Phase
Chronic Functional Constipation Device: micro-enema with Promelaxin Drug: Macrogol 4000 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized between two treatment arms
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 18, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: micro-enema with Promelaxin
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
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.
Other Name: Melilax

Active Comparator: Macrogol 4000
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).
Drug: Macrogol 4000
Stool softener
Other Name: Paxabel




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. score of the parents quality of life calculated on day 21 and 56 [ Time Frame: day 21 and day 56 ]
    parents quality of life questionnaire

  2. score of the children quality of life calculated on day 21 and 56 [ Time Frame: day 21 and day 56 ]
    children quality of life questionnaire

  3. Gastrointestinal symptoms in children on days 14, 21 and 56 [ Time Frame: day 14, day 21 and day 56 ]
    gastrointestinal symptoms recording through/following treatment

  4. changes in the intestinal microbioma on day 21 and 56 [ Time Frame: day 21 and day 56 ]
    the intestinal microbioma will be analysed in laboratory to see whether a treatment influence can be measured

  5. 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 ]
  6. Product Safety [ Time Frame: day 14, day 21 and day 56 ]
    Adverse events reported by parents/legal representative of the subject

  7. Change in stool consistency [ Time Frame: day 14, day 21 and day 56 ]
    Reduction of stool consistency with increase of 1 or more points on Bristol Stool Form Scale or Amsterdam scale



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Ages Eligible for Study:   6 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751411


Contacts
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Contact: Luca Franceschini, Dr. +39 0575746722 lfranceschini@aboca.it
Contact: Stefania Bozzola +39 010562234 bozzola@latiscro.it

Locations
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Italy
ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito Recruiting
L'Aquila, AQ, Italy, 67100
Contact: Alberto Verrotti, Prof.    +39 338 9473553    alberto.verrottidipianella@univaq.it   
Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19 Recruiting
Pavia, PV, Italy, 27100
Contact: Gian Luigi Marseglia, Prof.    0382502818    gl.marseglia@smatteo.pv.it   
Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II Recruiting
Napoli, Italy, 80131
Contact: Annamaria Staiano, Prof.    0817462679    staiano@unina.it   
AOU Università degli Studi della Campania "Luigi Vanvitelli" Recruiting
Napoli, Italy, 80138
Contact: Carlo Tolone, Prof.       carlo.tolone@unina2.it   
Sponsors and Collaborators
Aboca Spa Societa' Agricola
Eclisse - Euromed Clinical Supply Services Srl
Ceinge - Biotecnologie Avanzate s.c. a r.l.
Latis S.r.l.
PhAST Consulting Srl
Investigators
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Principal Investigator: Annamaria Staiano, Prof. Universita Federico II - Pediatric Department

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Responsible Party: Aboca Spa Societa' Agricola
ClinicalTrials.gov Identifier: NCT02751411     History of Changes
Other Study ID Numbers: ABO-MELI-15
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms