Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults
Condition: Colon Cancer; Colorectal Carcinoma; Colon Cleansing
MeSH terms: Colorectal Neoplasms
Intervention: NER1006; Trisulfate solution
Intervention description: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.; The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 621.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate
      Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that
      requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540
      patients will be randomised with the aim of achieving a minimum of 245 patients in each of
      the 2 groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Male and female outpatients and inpatients aged ≥18 to ≤85 years undergoing a
             screening, surveillance, or diagnostic colonoscopy

          -  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: 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)

          -  Willing, able and competent to complete study and comply with instructions.

        Exclusion Criteria:

          -  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.

          -  Patients with ongoing severe acute Inflammatory Bowel Disease (IBD).

          -  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.

          -  Regular use of laxatives or colon motility altering drugs in the last month (i.e. more
             than 2-3 times per week) and/or laxative use within 72 hours prior to administration
             of the preparation.

          -  Patients with active intestinal bleeding episodes or with a clinically significant low
             hemoglobin level <9 g/dL for women and <11 g/dL for men at screening.

          -  Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.

          -  Known phenylketonuria.

          -  Known hypersensitivity to polyethylene glycols, ascorbic acid and sulfates (not
             including sulfa-based products) or any other component of the investigational product
             or comparator.

          -  Past history within the last 12 months or evidence of any on-going clinically relevant
             electrocardiogram (ECG) abnormalities (e.g. arrhythmias).

          -  History of uncontrolled hypertension with systolic blood pressure >170 mmHg and
             diastolic blood pressure >100 mmHg.

          -  Patients with cardiac insufficiency NYHA grades III or IV.

          -  Patients with moderate to severe renal insufficiency (i.e. with GFR, <60
             mL/min/1.73m2).

          -  Patient with serum albumin < 3.4 g/dL.

          -  Patients with liver disease of grades B and C according to the Child Pugh
             classification.

          -  Patients suffering from dehydration at screening as evaluated by the Investigator from
             physical examination and laboratory investigations.

          -  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.

          -  Patients with any other clinically significant hematological parameters including
             coagulation profile at screening.

          -  Patients with impaired consciousness that might predispose them to pulmonary
             aspiration.

          -  Patients undergoing colonoscopy for foreign body removal and/or decompression.

          -  Patients who are pregnant or lactating, or intending to become pregnant during the
             study.

          -  Clinically relevant findings on physical examination based on the Investigator's
             judgment.

          -  History of drug or alcohol abuse within the 12 months prior to dosing.

          -  Concurrent participation in an investigational drug or device study or participation
             within three months of study entry.

          -  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.

          -  Patients who are ordered to live in an institution on court or authority order.