A Phase 3 interventional study of PMF104 and Klean-prep in Bowel Preparation Before Colonoscopy, sponsored by Alfasigma S.p.A.. Status unknown at 9 sites in 3 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-09-28.
Sponsored by Alfasigma S.p.A. · Phase 3, Interventional, and Treatment
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.
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:
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.
Alfasigma S.p.A. is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female subjects currently either of:
Exclusion Criteria:
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
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: * 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
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
Colon cleansing efficacy
Boston Bowel Preparation Scale score assessed blindly by the endoscopist
Time frame: Visit 3 (Day 2)
Time to reach clear watery stools
The time when clear watery stools are obtained after completing the bowel solution
Time frame: Day 1
Proportion of patients in whom caecal intubation was achieved during colonoscopy
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
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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Day 1
Palatability
Pre-determined answers to question:"How did the solution taste?" 1 =Very bad; 2 = Bad; 3 =Good; 4 = Very good
Time frame: 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).
Time frame: 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
Time frame: 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 1. =Mild distress 2. =Moderate distress 3. = Severe distress
Time frame: Visit 3 (Day 2)
Plan to share: No
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Alfasigma S.p.A.