Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
233
Countries
1
Sites
1
constipation
To test the efficacy of prophylactic treatment with PEG3350+E to prevent the onset of constipation in the critically ill child.
Key facts
- Sponsor
- Hospital General Universitario Gregorio Maranon
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 9 May 2025 → ongoing
- Decision date (initial)
- 2025-02-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Instituto de Salud Carlos III
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To test the efficacy of prophylactic treatment with PEG3350+E to prevent the onset of constipation in the critically ill child.
Secondary objectives 2
- To test the safety of PEG3350+E as a therapeutic option for constipation in the critically ill child.
- To compare stool consistency between constipated patients receiving prophylactic PEG3350+E and those receiving PEG3350+E as a treatment.
Conditions and MedDRA coding
constipation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10055500 | Constipation (excl fecal impaction) | 10017947 |
| 20.1 | LLT | 10063582 | Constipation chronic | 10017947 |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Not availlable
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509718-12-00 | Randomized controlled clinical trial on prophylactic treatment of constipation with polyethylene glycol with electrolytes in the critically ill child. | Hospital General Universitario Gregorio Maranon |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- o Paediatric patients admitted to the PICU (1 month-16 years of age) for an estimated time of more than 3 days. o Patients whose parents or legal guardians sign the informed consent form. In the case of mature minors (12-16 years of age), they will have to agree to be included. o Patients with a constipation development risk scale (Appendix 1) with a score > 6.2 points (high risk) assessed 48 hours after admission to PICU (day 0).
Exclusion criteria 1
- Patients previously affected or who at the time of admission present abdominal pathology involving gastrointestinal rhythm alteration (short bowel syndrome, paralytic ileus, etc.) and/or gastrointestinal surgery.. Patients who at 48 hours of admission to the PICU (Day 0) have not reached 80% of full enteral nutrition calculated for their weight and height (Appendix 4). Patients who have spontaneous transit before 48 hours of admission. Patients with chronic constipation and already undergoing pharmacological treatment for constipation regardless of the drug used. Women of childbearing age who are unwilling or unable to use an effective barrier method of contraception. Hypersensitivity to any component of the study drug formulation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- - Efficacy assessment: the primary endpoint is stool output.
Secondary endpoints 2
- • Safety assessment: any adverse events
- Assessment of stool consistency: the validated Bristol scale will be used.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Movicol Pediátrico Sabor Neutro 6,9 g polvo para solución oral en sobre.
PRD320551 · Product
- Active substance
- Sodium Hydrogen Carbonate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 0.35 g gram(s)
- Max total dose
- 41.1 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- A06AD65 — MACROGOL, COMBINATIONS
- Marketing authorisation
- 67.853
- MA holder
- NORGINE HEALTHCARE B.V.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital General Universitario Gregorio Maranon
- Sponsor organisation
- Hospital General Universitario Gregorio Maranon
- Address
- Calle Del Doctor Esquerdo 46
- City
- Madrid
- Postcode
- 28009
- Country
- Spain
Scientific contact point
- Organisation
- Hospital General Universitario Gregorio Maranon
- Contact name
- Jorge Lopez
Public contact point
- Organisation
- Hospital General Universitario Gregorio Maranon
- Contact name
- Jorge Lopez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 233 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-05-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 protocol 202-509718-12-01 | 2.8 |
| Protocol (for publication) | Protocolo estudio PEM3350 | 1 |
| Recruitment arrangements (for publication) | K Recruitment and Informed consent procedure template FOR PUBLICATION | 1 |
| Subject information and informed consent form (for publication) | CI padrestutores 08102024 cc | 1 |
| Subject information and informed consent form (for publication) | CI padrestutores 08102024 limpio | 1 |
| Subject information and informed consent form (for publication) | Informacion menor maduro version 2 6 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SmPC MOVICOL_NEUTRO | 1 |
| Synopsis of the protocol (for publication) | D1 PROTOCOL SYNOPSIS ESP VERSION | 2.8 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-15 | Spain | Acceptable 2025-01-22
|
2025-02-04 |