Bowel cleansing prior to any procedure that requires a clean bowel, e.g. colonoscopy, surgical, video capsule or radiological procedures.
Conditions
Sponsors
Norgine Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be entered into this study only if they satisfy the following criteria: 1.Patients must provide written informed consent. 2.Male and female outpatients and inpatients aged: =18 to =85 years undergoing a screening, surveillance or diagnostic colonoscopy. 3.Females of child bearing potential must have a negative pregnancy test at Screening and at Visit 2 and must be practising one of the following methods of birth control and agree to continue with the regimen throughout the study period (unless post-menopausal or surgically sterile): •Oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; •Intrauterine device in combination with a condom; •Double barrier method (condom* and occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository). *A female condom and a male condom should not be used together as friction between the two can result in either product failing. If any female patient has a positive pregnancy test at Visit 2, they will be excluded from further participation in the study for the efficacy evaluation, i.e. they will not undergo the colonoscopy procedure. The Investigator will be required to arrange a colonoscopy procedure outside of the study. Note: The above birth control methods do not apply to females who are postmenopausal or surgically sterile i.e. 12 months of natural (spontaneous) amenorrhea or 6 weeks’ post-surgical bilateral oophorectomy with or without hysterectomy or hysterectomy, or whose sole sexual partner has had a vasectomy and has received medical assessment of the surgical success. 4.Willing, able and competent to complete the entire study and to comply with instructions. 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 345 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 185
Exclusion criteria
Exclusion criteria: Patients will be excluded from this study if they meet any of the following criteria: 1.Patients with past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. 2.Patients with ongoing severe acute Inflammatory Bowel Disease (IBD). 3.Patients who have had previous significant gastrointestinal surgeries, including colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning colostomy, Hartmann’s procedure and de-functioning ileostomy or other similar surgeries involving structure and function of the small or large colon. 4.Regular use of laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) in the last 28 days prior to the Screening Visit and/or laxative use within 72 hours prior to administration of the preparation. 5.Patients with active intestinal bleeding episodes or with a clinically significant low hemoglobin level 170 mmHg and diastolic blood pressure >100 mmHg. 11.Patients with cardiac insufficiency NYHA grades III or IV. 12.Patients with moderate to severe renal insufficiency (i.e. with GFR, <60 mL/min/1.73m2). 13.Patient with serum albumin <3.4 g/dL. 14.Patients with known liver disease of grades B and C according to the Child Pugh classification. 15.Patients suffering from dehydration at screening as evaluated by the Investigator from physical examination and laboratory investigations. 16.Patients with clinically significant electrolyte abnormalities, whether pre-existing or noted at screening, such as hypernatremia, hyponatremia, hyperphosphatemia, hypermagnesemia, hypokalemia, hypocalcaemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors. 17.Patients with any other clinically significant hematological parameters including coagulation profile at screening. 18.Patients with impaired consciousness that might predispose them to pulmonary aspiration. 19.Patients undergoing colonoscopy for foreign body removal and/or decompression. 20.Patients who are pregnant or lactating, or intending to become pregnant during the study. 21.Clinically relevant findings on physical examination based on the Investigator’s judgment. 22.History of drug or alcohol abuse within the 12 months prior to dosing. 23.Concurrent participation in an investigational drug or device study or participation within three months of study entry. 24.Patients who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures, e.g. cognitively impaired, debilitated or fragile patients. 25.Patients who are ordered to live in an institution on cou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare NER1006 to SP+MS with respect to the following: Primary Objectives: To evaluate the overall bowel cleansing efficacy and the ‘Excellent plus Good’ cleansing rate in the colon ascendens of a 1-day day before-only split-dosing regimen with NER1006 compared to a 1-day day before-only split-dosing regimen with SP+MS, graded according to the Harefield Cleansing Scale© (HCS©) in patients undergoing screening, surveillance or diagnostic colonoscopy. ;Secondary Objective: 1.To assess the Adenoma Detection Rate (ADR) with NER1006 compared to SP+MS for the colon ascendens. 2.To assess the overall ADR with NER1006 compared to SP+MS. 3.To assess the Polyp Detection Rate (PDR) with NER1006 compared to SP+MS for the colon ascendens. 4.To assess the overall PDR with NER1006 compared to SP+MS. Supportive Secondary Objectives: 1.To evaluate the segmental bowel cleansing efficacy of NER1006 compared to SP+MS, graded according to the HCS in patients undergoing screening, surveillance or diagnostic colonoscopy for each of the other four colon segments (colon transversum, colon descendens, colon sigmoidum and rectum). 2.To assess the bowel cleansing quality with NER1006 compared to SP+MS using the Boston Bowel Preparation Scale (BBPS). 3.To assess tolerability using PRO (BOCLIR).(NB-latter for use in the UK only) 4.To assess patient compliance and acceptability using PRO. Safety Objective: To evaluate the safety of NER1006 compared to SP+MS. ;Primary end point(s): 1.The overall bowel cleansing success rate of NER1006 is non-inferior to that of SP+MS using the HCS, wherein success corresponds to Grades A and B, and failure corresponds to Grades C and D. 2.The ‘Excellent plus Good’ cleansing rate in the colon ascendens of NER1006 is non-inferior to that of SP+MS using the segmental cleansing scoring system of the HCS, wherein the ordinal score of 4 corresponds to Excellent cleansing and score of 3 corresponds to Good cleansing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: •ADR as defined by the proportion of patients with at least one adenoma in the colon ascendens as confirmed by a pathologist. •ADR as defined by the proportion of patients with at least one adenoma in the overall colon as confirmed by a pathologist. •PDR as defined by the proportion of patients with at least one polyp in the colon ascendens, as confirmed by the colonoscopist. •PDR as defined by the proportion of patients with at least one polyp in the overall colon as confirmed by the colonoscopist. Supportive secondary endpoints: •The ‘Excellent plus Good’ cleansing rate for the other four colon segments (colon transversum, colon descendens, colon sigmoidum and rectum) using the HCS. •Bowel cleansing success rates using the Boston Bowel Preparation Scale. •To assess the tolerability using patient reported outcomes (PRO) (BOCLIR where applicable). •To assess patient compliance and acceptability using PRO. ;Timepoint(s) of evaluation of this end point: Segmental cleaning scores during colonoscopy | — |
Countries
Germany, Netherlands, Poland, Spain, United Kingdom
Contacts
Public ContactAD, Clinical Development
Norgine Ltd
Outcome results
None listed