A Trial to Evaluate the Efficacy and Safety of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children

NCT03106922 | Unknown Phase 3

• 1 other identifier: PMF104 PD1-2-3/2013
• Study Type: interventional
• Target: 430
• Locations: 3 countries
• Sites: 9

Brief Summary

A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to a conventional PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning the colon.

Conditions

Bowel Preparation Before Colonoscopy

Keywords

Polyethylene glycol; Bowel cleansing; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Colon cleansing efficacy

  Boston Bowel Preparation Scale score assessed blindly by the endoscopist

  Visit 3 (Day 2)

Secondary Outcomes (10)

• Time to reach clear watery stools

  Day 1

• Proportion of patients in whom caecal intubation was achieved during colonoscopy

  Visit 3 (Day 2)

• Proportion of patients achieving a BBPS score greater than or equal to 5

  Visit 3 (Day 2)

• Proportion of patients that needs a rescue dose

  Day 1

• Compliance

  Day 1

Study Arms (2)

PMF104

EXPERIMENTAL

The day before the colonoscopy, starting in the mid-late afternoon (4-6 p.m.), by oral route: 2\<=Age\<6 * 500 ml in 1-1.5 hours \<= to 18 kg * 625 ml in 1-1.5 hours \>18 kg 6\<=Age\<12: * 750 ml in 1-2 hours \<=25 kg * 1000 ml in 1-2 hours 25-35 kg * 1250 ml in 1-2 hours \>35 kg 12\>=Age\<18 : * 1500 ml in 2-3 hours \<= 45 kg * 1750 ml in 2-3 hours\>45 kg. Rescue dose (if no clear watery stools 3 hours after the entire solution): * 250 ml 2 Age \<=6; * 500 ml 6 \<=Age\<12; up to a cumulative maximum volume of 2000 ml 12\<=Age\<18.

Drug: PMF104

Klean- prep

ACTIVE COMPARATOR

The day before the colonoscopy, starting in the mid-late afternoon (4-6 p.m.), by oral route: * 2\<=Age\<6: * 90 ml/kg in 1-1.5 hours 2\<=Age\<6 * 80 ml/kg in 1-1.5 hours 5\<=Age\<6 * 2\<=Age\<6: * 80 ml/kg in 1-2 hours 6\<=Age\<10 * 70 ml/kg in 1-2 hours 10\<=Age\<12 * 12\<=Age\<18: * 70 ml/kg in 2-3 hours. Rescue dose (if no clear watery stools 3 hours after the entire Klean-Prep solution): 50% of the initial dose.

Drug: Klean-prep

Interventions

PMF104 DRUG

Powder for oral solution: * Sachet A: macrogol 4000 52.500 g, anhydrous sodium sulphate 3.750 g, simeticone 0.080 g; * Sachet B: sodium citrate 1.863 g, anhydrous citric acid 0.813 g, sodium chloride 0.730 g, potassium chloride 0.370 g; One sachet A + 1 sachet B in 500 ml of water

PMF104

Klean-prep DRUG

Powder for oral solution: macrogol 3350 59.000 g, anhydrous sodium sulphate 5.685 g, sodium bicarbonate 1.685 g, sodium chloride 1.465 g, potassium chloride 0.7425 g. One sachet to be dissolved in 1 L of water

Klean- prep

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female patients aged from 2 to less than 18 years during the entire study period undergoing elective colonoscopy;
• Female subjects currently either of:
• Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is surgically sterilised via documented hysterectomy or bilateral tubal ligation), or
• Childbearing potential: the subject is eligible to enter and participate in this study if she is not lactating and has a negative pregnancy test, and agrees to abstain from intercourses until the colonoscopy is performed (only menstruated females);
• Patients whose parents/legal representatives have been thoroughly informed of the aim of the study procedures and provided signed and dated written informed consent;
• Children aged from 6 to less than 12 years providing informed assent whenever possible;
• Adolescents aged from 12 to less than 18 years providing informed assent;
• Ability of the subjects and/or their parents/legal representatives to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

You may not qualify if:

• Requirement for urgent colonoscopy;
• Gastrointestinal obstruction or perforation;
• Bowel pseudo-obstruction;
• Gastric retention;
• Toxic colitis;
• Toxic megacolon;
• Known or suspected hypersensitivity to the active or other ingredients of both test product and reference product;
• Clinically significant electrolyte imbalance;
• Prior intestinal resection;
• Structural abnormality of the lower gastrointestinal (GI) tract;
• Known metabolic (particularly phenylketonuria), hepatic, renal or cardiac disease;
• Congestive heart failure (NYHA class III and IV);
• Known pregnancy;
• Subject who have participated in another clinical trial or have taken an investigational drug within the last 3 months prior screening.

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (9)

Pediatric Gastroenterology, Hepatology and Nutrition Children's University Hospital

Brussels, 1090, Belgium

NOT YET RECRUITING

Hôpital Jeanne de Flandre

Lille, 59037, France

NOT YET RECRUITING

University and Pediatric Hospital of Lyon

Lyon, 69677, France

NOT YET RECRUITING

Hôpital Armand-Trousseau

Paris, 75571, France

NOT YET RECRUITING

Ospedale Maggiore "C.A. Pizzardi" AUSL Bologna

Bologna, 40133, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliero-Universitaria Meyer

Florence, 50139, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria "G. Martino"

Messina, 98123, Italy

NOT YET RECRUITING

Azienda Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

Ospedale Pediatrico Bambino Gesù

Rome, 00165, Italy

RECRUITING

MeSH Terms

Interventions

klean prep

Study Officials

• Salvatore Cucchiara, MD

  Azienda Policlinico Umberto I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaella Tacchi, MD

CONTACT

+39 051 6489867; rtacchi@alfawassermann.it

Michela Padovani, MSc

CONTACT

+39 051 6489599; mpadovani@alfawassermann.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the study a single-blind design with respect to the investigational products will be achieved by providing the randomisation list only to the unblinded study staff personnel who will handle study drug management, preparation, dispensation and collection but who will not be involved in colonoscopy performing. The colonoscopy will be performed by experienced endoscopists who are unaware of the treatment actually being dispensed in each case. The endoscopist will be blinded by instructing all the other involved clinical staff, patients and patients' families to not discuss with him the specifics of the preparation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 11, 2017
• Study Start: April 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 28, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (3); IT (5)