Bowel cleansing to ensure the preparation of patient prior to colonic surgery or colon endoscopic or radiological diagnostic procedures MedDRA version: 14.1 Level: PT Classification code 10066943 Term: Bowel preparation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: COLOKIT
Pharmaceutical Form: Tablet
INN or Proposed INN: SODIUM PHOSPHATE MONOBASIC MONOHYDRATE
CAS Number: 10049-21-5
Other descriptive name: SODIUM PHOSPHATE MONOBASIC MONOHYDRATE
Concen
Sponsors
LABORATOIRES MAYOLY SPINDLER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Written informed consent form. (2) Men and women aged from 18 to 75 years (included). (3) Scheduled for a colonoscopy as an outpatient. (4) Normal renal function (eGFR greater or equal to 60 mL/mn/1.73m2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 224 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 224
Exclusion criteria
Exclusion criteria: (1) Pregnant woman or likely to be (without contraception) or breast feeding. (2) Having a disease or condition as follows: - clinically significant abnormal electrolytes values (sodium, phosphate, potassium, calcium), - primary hyperparathyroidism associated with hypercalcemia, - congestive heart failure Class III and IV (Am. Heart Assoc., NYHA Classification), - unstable angina pectoris or recent myocardial infarction, PTCA or coronary artery bypass surgery within previous 3 months - ascites, - known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis, - inflammatory bowel disease, - history of gastric stapling or bypass procedure or gastric retention - history of colonic resection, except partial resection of the sigmoid - severe chronic constipation (< 2 bowel movements per week) - swallowing difficulties - any other clinical condition which, in the opinion of the investigator, would not allow the subject to participate in the study in good conditions. (3) Sodium phosphate preparation taken within the past three weeks prior to colonoscopy. (4) Drugs that affect renal perfusion or function, including diuretics, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptors blockers or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) (occasional NSAIDs use is permitted) initiated within 4 weeks prior to first study drug intake, (5) Concomitant use of medications known to prolong the QT interval. (6) Known allergy to any of the active ingredients or excipients of the study drugs. (7) History of phenylketonuria (8) Subjects who have participated in a clinical trial in the previous 30 days. (9) Subjects deprived of freedom by judicial or administrative decision, hospitalized without their consent or for other reasons than the research, under legal protection or unable to express their consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy of sodium phosphate tablets versus split dose of 4 liters of PEG for bowel cleansing prior to colonoscopy.;Secondary Objective: Secondary objectives will include: - patient's acceptability - tolerability - safety, in term of physical examination, vital signs, adverse events, and blood tests - study medication compliance;Primary end point(s): Efficacy: Quality Score of bowel preparation with Boston Bowel Preparation Scale (BBPS);Timepoint(s) of evaluation of this end point: During the colonoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Proportion of patients with 'adequate' cleansing for the right colon segment (segment score > or = to 2). - Proportion of patients with 'adequate' cleansing for the transverse colon segment (segment score > or = to 2). - Proportion of patients with 'adequate' cleansing for the left colon segment (segment score > or = to 2). - Proportion of completed colonoscopies (intubation of the cecum) and proportion of rescheduled colonoscopies. - Relationship of the BBPS score and the percentage of patients who completed the colonoscopy (intubation of the cecum). - Polyps detection rate (percentage of patients with at least one polyp detected). - Polyps detection rate by location (colon segment). - Mean number of polyps per patient detected per size ( or = to 10 mm). Acceptability: - Proportion of patients with 'very acceptable' acceptability, based on a 4-points Likert scale. - Proportion of patients willing to repeat the same bowel preparation. - Proportion of patients who assessed the product taste as 'no taste', based on a 4-points Likert scale. - Proportion of patients who assessed the easiness to take the product as 'easy', based on a 4-points Likert scale. Tolerability: - Proportion of patients experiencing nausea, vomiting, abdominal pain, abdominal bloating. - Severity of nausea, vomiting, abdominal pain, abdominal bloating using a 4-point Likert scale. Compliance: - Patient's compliance based on the assessment of study drug intake. Safety: Proportion of patients with TEAEs by System and Organ Class (SOC) and Preferred Term (PT) using MedDRA terminology. Diarrhoea is an expected outcome of study drug with bowel preparation, will not be captured as an adverse event unless it is a serious adverse event. It is also expected that some cancers will be detected during colonoscopy; these will not be considered as serious adverse events. Polyps and diverticuli found during the colonoscopy will not be considered as adverse events, because | — |
Countries
Spain
Contacts
Public ContactProject Manager
NUVISAN ONCOLOGY SA
Outcome results
None listed