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

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ClinicalTrials.gov Identifier: NCT03106922
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Alfasigma S.p.A.

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.

Condition or disease Intervention/treatment Phase
Bowel Preparation Before Colonoscopy Drug: PMF104 Drug: Klean-prep Phase 3

Detailed Description:

The aim of the study is to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to Klean-prep® in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon.

Patients will be stratified according the following age strata:

  • Children from 2 to less than 6 years of age (PMF104 PD1/13)
  • Children from 6 to less than 12 years of age (PMF104 PD2/13)
  • Children from 12 to less than 18 years of age (PMF104 PD3/13) The study will consist of a Screening Visit (V1), a Randomisation Visit (V2), a Drug Administration (Day 1), a Diagnostic Procedure (i.e. colonoscopy; V3) and a Follow-up Telephone Contact (FU).

At Screening Visit (V1) children will be evaluated for study eligibility, up to 11 days before the colonoscopy.

At Randomisation Visit (V2), if eligible, they will be randomised according to a single blind randomisation schedule in a 1:1 ratio to PMF104 or Klean-prep®; they will also receive the instructions to be followed for bowel preparation, and the questionnaire to be answered on the day of the bowel preparation. In case the Investigator will consider it as appropriate, the child will be hospitalised in the clinical facility the day before the colonoscopy in order to perform bowel preparation.

The day before the colonoscopy study drug will be administered orally starting in the mid-late afternoon (4-6 p.m.), as single dose.

The day of colonoscopy the diagnostic procedure will be performed blindly by an endoscopist unaware of the treatment administered to the subject, and both primary and secondary endpoints will be assessed.

On day 31 ± 2 (i.e. 30 ± 2 days after the day of the bowel preparation intake), the subjects will be contacted by a telephone call, to inquire about possible adverse events occurred after hospital discharge.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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 Children Aged From 2 to Less Than 6, From 6 to Less Than 12, and Adolescents From 12 to Less Than 18 Years of Age Requiring a Diagnostic Procedure Concerning the Colon
Study Start Date : April 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: PMF104

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

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


Active Comparator: Klean- prep

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

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





Primary Outcome Measures :
  1. Colon cleansing efficacy [ Time Frame: Visit 3 (Day 2) ]
    Boston Bowel Preparation Scale score assessed blindly by the endoscopist


Secondary Outcome Measures :
  1. Time to reach clear watery stools [ Time Frame: Day 1 ]
    The time when clear watery stools are obtained after completing the bowel solution

  2. Proportion of patients in whom caecal intubation was achieved during colonoscopy [ Time Frame: Visit 3 (Day 2) ]
    Proportion of patients in whom caecal intubation was achieved during colonoscopy

  3. Proportion of patients achieving a BBPS score greater than or equal to 5 [ Time Frame: Visit 3 (Day 2) ]
    Based on the BBPS score assigned during colonoscopy, each patient will be classified as being a "success" (patient achieving a BBPS score ≥ 5) or a "failure" (patient achieving a BBPS score < 5).

  4. Proportion of patients that needs a rescue dose [ Time Frame: Day 1 ]
    Additional amount of test or reference will be given if patient will not have clear watery stools 3 hours after the administration of the scheduled amount of bowel solution

  5. Compliance [ Time Frame: Day 1 ]
    Poor: intake of < 75% of the solution; Good: intake of at least 75% of the solution but <100%; Optimal: intake of the whole solution.

  6. Acceptability [ Time Frame: Day 1 ]
    Pre-determined answers to question:"How difficult was to drink the bowel preparation solution?" 1 =Very difficult; 2 =Moderately difficult; 3 = Slightly difficult; 4 =Not difficult at all

  7. Palatability [ Time Frame: Day 1 ]
    Pre-determined answers to question:"How did the solution taste?" 1 =Very bad; 2 = Bad; 3 =Good; 4 = Very good

  8. Number of adverse events [ Time Frame: From Visit 1 to Follow-up telephone contact ]
    Number of adverse events coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).

  9. Subjects withdrawn due to treatment emergent adverse events (TEAEs) [ Time Frame: From Visit 1 to Follow-up telephone contact ]
    Number and percentage of patients withdrawn due to TEAEs

  10. Tolerability Assessment [ Time Frame: Visit 3 (Day 2) ]

    Recording of occurence and severity of nausea, vomiting, bloating, abdominal pain/cramps, anal irritation and fatigue/weakness, according to a 4 point scale:

    0 =No distress

    1. =Mild distress
    2. =Moderate distress
    3. = Severe distress



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients aged from 2 to less than 18 years during the entire study period undergoing elective colonoscopy;
  2. 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);
  3. Patients whose parents/legal representatives have been thoroughly informed of the aim of the study procedures and provided signed and dated written informed consent;
  4. Children aged from 6 to less than 12 years providing informed assent whenever possible;
  5. Adolescents aged from 12 to less than 18 years providing informed assent;
  6. Ability of the subjects and/or their parents/legal representatives to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

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

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): NCT03106922


Contacts
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Contact: Raffaella Tacchi, MD +39 051 6489867 rtacchi@alfawassermann.it
Contact: Michela Padovani, MSc +39 051 6489599 mpadovani@alfawassermann.it

Locations
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Belgium
Pediatric Gastroenterology, Hepatology and Nutrition Children's University Hospital Not yet recruiting
Brussel, Belgium, 1090
Contact: Genevieve Veereman       gveereman@mail.com   
Principal Investigator: Genevieve Veereman, MD         
France
Hôpital Jeanne de Flandre Not yet recruiting
Lille, France, 59037
Contact: Laurent Michaud, MD       Laurent.MICHAUD@CHRU-LILLE.FR   
Principal Investigator: Laurent Michaud, MD         
University and Pediatric Hospital of Lyon Not yet recruiting
Lyon, France, 69677
Contact: Alain Lachaux, MD       alain.lachaux@chu-lyon.fr   
Principal Investigator: Alain Lachaux, MD         
Hôpital Armand-Trousseau Not yet recruiting
Paris, France, 75571
Contact: Julie Lemale, MD       julie.lemale@aphp.fr   
Principal Investigator: Julie Lemale, MD         
Italy
Ospedale Maggiore "C.A. Pizzardi" AUSL Bologna Active, not recruiting
Bologna, Italy, 40133
Azienda Ospedaliero-Universitaria Meyer Active, not recruiting
Florence, Italy, 50139
Azienda Ospedaliera Universitaria "G. Martino" Not yet recruiting
Messina, Italy, 98123
Contact: Claudio Romano, MD       romanoc@unime.it   
Principal Investigator: Claudio Romano, MD         
Azienda Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Salvatore Cucchiara, MD    06 49979326    salvatore.cucchiara@uniroma1.it   
Principal Investigator: Salvatore Cucchiara, MD         
Sub-Investigator: Salvatore Oliva, MD         
Sub-Investigator: Saverio Mallardo, MD         
Ospedale Pediatrico Bambino Gesù Recruiting
Rome, Italy, 00165
Contact: Luigi Dall'Oglio, MD    +39 0668592841    luigi.dalloglio@opbg.net   
Principal Investigator: Luigi Dall'Oglio, MD         
Sub-Investigator: Giuseppe Pontrelli, MD         
Sponsors and Collaborators
Alfasigma S.p.A.
Investigators
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Principal Investigator: Salvatore Cucchiara, MD Azienda Policlinico Umberto I

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Responsible Party: Alfasigma S.p.A.
ClinicalTrials.gov Identifier: NCT03106922     History of Changes
Other Study ID Numbers: PMF104 PD1-2-3/2013
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alfasigma S.p.A.:
Polyethylene glycol
Bowel cleansing
Colonoscopy

Additional relevant MeSH terms:
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Pharmaceutical Solutions