A Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 (a Low Volume Bowel Cleansing Solution) versus a Sodium Picosulfate and Magnesium Salt (SP+MS) Solution Using a Day Before-Only Dosing Regimen in Adults

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 (condoms, sponge diaphragm, or vaginal ring
with spermicidal jellies or cream);
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.
4.Willing, able and competent to complete the entire study and to
comply with instructions.

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 defunctioning
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 <9 g/dL for women and <11 g/dL for
men at screening.
6.Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
7.Known phenylketonuria.
8.Known hypersensitivity to polyethylene glycols, ascorbic acid, sulfates (not including sulfa-based products), sodium picosulfate and magnesium salt compounds, or any other component of the investigational product or comparator.
9.Past history within the last 12 months or evidence of any on-going
clinically relevant electrocardiogram (ECG) abnormalities (e.g.
arrhythmias).
10.History of uncontrolled hypertension with systolic blood pressure
>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 court or authority
order.
26.Patients with a history of rhabdomyolysis.