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 (NOCT)

Norgine

Status and phase

Completed

Phase 3

Conditions

Colorectal Carcinoma

Colon Cleansing

Colon Cancer

Treatments

Drug: NER1006

Drug: Trisulfate solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT02254486

29672 (Other Identifier)

NER1006-01/2014 (NOCT)

Details and patient eligibility

About

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.

Enrollment

621 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.