Bowel Preparation Before ColonoscopyPhase 3NCT03106922
A Trial to Evaluate the Efficacy and Safety of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children
A Phase 3 study testing PMF104 and Klean-prep in people with Bowel Preparation Before Colonoscopy, run by Alfasigma S.p.A. at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Bowel Preparation Before Colonoscopy
- What is being tested?
- PMF104 and Klean-prep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Apr 2016to Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Requirement for urgent colonoscopy;
- Gastrointestinal obstruction or perforation;
- Bowel pseudo-obstruction;
- Gastric retention;
- Toxic colitis;
- Toxic megacolon;
Show all 14Show fewer
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Italy5 sites, 3 recruiting
- Active, not recruiting
Ospedale Maggiore "C.A. Pizzardi" AUSL Bologna
Bologna, 40133
- Active, not recruiting
Azienda Ospedaliero-Universitaria Meyer
Florence, 50139
- Not yet recruiting
Azienda Ospedaliera Universitaria "G. Martino"
Messina, 98123
Claudio Romano, MD, romanoc@unime.it
Claudio Romano, MD
- Recruiting
Azienda Policlinico Umberto I
Rome, 00161
Salvatore Cucchiara, MD, 06 49979326, salvatore.cucchiara@uniroma1.it
Salvatore Cucchiara, MD
- Recruiting
Ospedale Pediatrico Bambino Gesù
Rome, 00165
Luigi Dall'Oglio, MD, +39 0668592841, luigi.dalloglio@opbg.net
Luigi Dall'Oglio, MD
France3 sites, 3 recruiting
- Not yet recruiting
Hôpital Jeanne de Flandre
Lille, 59037
Laurent Michaud, MD, Laurent.MICHAUD@CHRU-LILLE.FR
Laurent Michaud, MD
- Not yet recruiting
University and Pediatric Hospital of Lyon
Lyon, 69677
Alain Lachaux, MD, alain.lachaux@chu-lyon.fr
Alain Lachaux, MD
- Not yet recruiting
Hôpital Armand-Trousseau
Paris, 75571
Julie Lemale, MD, julie.lemale@aphp.fr
Julie Lemale, MD
Belgium1 site, 1 recruiting
- Not yet recruiting
Pediatric Gastroenterology, Hepatology and Nutrition Children's University Hospital
Brussels, 1090
Genevieve Veereman, gveereman@mail.com
Genevieve Veereman, MD
About this study
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
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.
Read the 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.
- Conditions
- Bowel Preparation Before Colonoscopy
- Being tested
- PMF104, Klean-prep
- Keywords
- Polyethylene glycol, Bowel cleansing, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMF104Drug
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
Klean-prepDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Klean-prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colon cleansing efficacy
Boston Bowel Preparation Scale score assessed blindly by the endoscopist
Measured: Visit 3 (Day 2)
Secondary outcomes (10)
Time to reach clear watery stools
The time when clear watery stools are obtained after completing the bowel solution
Measured: Day 1
Proportion of patients in whom caecal intubation was achieved during colonoscopy
Proportion of patients in whom caecal intubation was achieved during colonoscopy
Measured: Visit 3 (Day 2)
Proportion of patients achieving a BBPS score greater than or equal to 5
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).
Measured: Visit 3 (Day 2)
Proportion of patients that needs a rescue dose
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
Measured: Day 1
Compliance
Poor: intake of < 75% of the solution; Good: intake of at least 75% of the solution but <100%; Optimal: intake of the whole solution.
Measured: Day 1
Acceptability
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
Measured: Day 1
Palatability
Pre-determined answers to question:"How did the solution taste?" 1 =Very bad; 2 = Bad; 3 =Good; 4 = Very good
Measured: Day 1
Number of adverse events
Number of adverse events coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: From Visit 1 to Follow-up telephone contact
Subjects withdrawn due to treatment emergent adverse events (TEAEs)
Number and percentage of patients withdrawn due to TEAEs
Measured: From Visit 1 to Follow-up telephone contact
Tolerability Assessment
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
- =Mild distress
- =Moderate distress
- = Severe distress
Measured: Visit 3 (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startApr 2016
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation Before ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Cucchiara, MD, Principal investigator, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106922
- Sponsor's protocol ID
- PMF104 PD1-2-3/2013
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03106922
- Acronym / sponsor ID
- PMF104 PD1-2-3/2013
- Conditions
- Bowel Preparation Before Colonoscopy
- Keywords
- Polyethylene glycol, Bowel cleansing, Colonoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMF104 | Experimental | Drug: PMF104The 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. |
| Klean- prep | Active comparator | Drug: Klean-prepThe 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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:
- 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;
Key exclusion criteria (14 listed)
- Requirement for urgent colonoscopy;
- Gastrointestinal obstruction or perforation;
- Bowel pseudo-obstruction;
- Gastric retention;
- Toxic colitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMF104Powder 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 | Drug | PMF104 |
| Klean-prepPowder 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 | Drug | Klean- prep |
Primary outcome
Colon cleansing efficacy
Time frame: Visit 3 (Day 2)
Boston Bowel Preparation Scale score assessed blindly by the endoscopist
10 secondary outcomes
Time to reach clear watery stools
Time frame: Day 1
Proportion of patients in whom caecal intubation was achieved during colonoscopy
Time frame: Visit 3 (Day 2)
Proportion of patients achieving a BBPS score greater than or equal to 5
Time frame: Visit 3 (Day 2)
Proportion of patients that needs a rescue dose
Time frame: Day 1
Compliance
Time frame: Day 1
Acceptability
Time frame: Day 1
Palatability
Time frame: Day 1
Number of adverse events
Time frame: 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
Tolerability Assessment
Time frame: Visit 3 (Day 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Cucchiara, MD principal investigator
Azienda Policlinico Umberto I
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PMF104 and Klean-prep in people with Bowel Preparation Before Colonoscopy, run by Alfasigma S.p.A. at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaella Tacchi, MD (+39 051 6489867, rtacchi@alfawassermann.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colon cleansing efficacy (time frame: Visit 3 (Day 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.