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

September 27, 2018 updated by: Alfasigma S.p.A.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • Not yet recruiting
        • Pediatric Gastroenterology, Hepatology and Nutrition Children's University Hospital
        • Contact:
        • Principal Investigator:
          • Genevieve Veereman, MD
  • France
      • Lille, France, 59037
        • Not yet recruiting
        • Hôpital Jeanne de Flandre
        • Contact:
        • Principal Investigator:
          • Laurent Michaud, MD
      • Lyon, France, 69677
        • Not yet recruiting
        • University and Pediatric Hospital of Lyon
        • Contact:
        • Principal Investigator:
          • Alain Lachaux, MD
      • Paris, France, 75571
        • Not yet recruiting
        • Hôpital Armand-Trousseau
        • Contact:
  • Italy
      • Bologna, Italy, 40133
        • Active, not recruiting
        • Ospedale Maggiore "C.A. Pizzardi" AUSL Bologna
      • Florence, Italy, 50139
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria Meyer
      • Messina, Italy, 98123
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria "G. Martino"
        • Contact:
        • Principal Investigator:
          • Claudio Romano, MD
      • Rome, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesu
        • Contact:
        • Principal Investigator:
          • Luigi Dall'Oglio, MD
        • Sub-Investigator:
          • Giuseppe Pontrelli, MD
      • Rome, Italy, 00161
        • Recruiting
        • Azienda Policlinico Umberto I
        • Contact:
        • Principal Investigator:
          • Salvatore Cucchiara, MD
        • Sub-Investigator:
          • Salvatore Oliva, MD
        • Sub-Investigator:
          • Saverio Mallardo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Colon cleansing efficacy
Time Frame: Visit 3 (Day 2)
Boston Bowel Preparation Scale score assessed blindly by the endoscopist
Visit 3 (Day 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to reach clear watery stools
Time Frame: Day 1
The time when clear watery stools are obtained after completing the bowel solution
Day 1
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
Visit 3 (Day 2)
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).
Visit 3 (Day 2)
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
Day 1
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.
Day 1
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
Day 1
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
Day 1
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).
From Visit 1 to Follow-up telephone contact
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
From Visit 1 to Follow-up telephone contact
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
Visit 3 (Day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alfasigma S.p.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Salvatore Cucchiara, MD, Azienda Policlinico Umberto I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PMF104 PD1-2-3/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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