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

NCT ID: NCT02254486

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 621 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-06-30

Brief 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.

Conditions

Colon Cancer; Colorectal Carcinoma; Colon Cleansing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

NER1006, 2-Day Split-Dosing

NER1006:2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)

Group Type: EXPERIMENTAL

NER1006

Intervention Type: DRUG

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.

Trisulfate Solution, 2-Day Split-Dosing

Trisulfate Solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)

Group Type: ACTIVE_COMPARATOR

Trisulfate solution

Intervention Type: DRUG

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.

Interventions

NER1006

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.

Intervention Type: DRUG

Trisulfate solution

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Demicco

Role: PRINCIPAL_INVESTIGATOR

Anaheim Clinical Trials, CA

Locations

Anaheim Clinical Trials

Anaheim, California, United States

Investigative Clinical Research

Annapolis, Maryland, United States

MGG Group Co., Inc., Chevy Chase Clinical

Chevy Chase, Maryland, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Long Island Gastrointestinal Research Group, LLP

Great Neck, New York, United States

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Peters Medical Research

High Point, North Carolina, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Trial Management Associates, LLC

Wilmington, North Carolina, United States

Consultants for Clinical Research

Cincinnati, Ohio, United States

Investigative Clinical Research, LLC

Mentor, Ohio, United States

Advanced Research Institute

Ogden, Utah, United States

Countries

United States

References

DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10.

Reference Type: BACKGROUND

PMID: 28803744 (View on PubMed)

Cash BD, Allen C, Poppers DM. Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials. BMC Gastroenterol. 2022 Sep 5;22(1):412. doi: 10.1186/s12876-022-02484-7.

Reference Type: DERIVED

PMID: 36064325 (View on PubMed)

Other Identifiers

29672

Identifier Type: OTHER

Identifier Source: secondary_id

NER1006-01/2014 (NOCT)

Identifier Type: -

Identifier Source: org_study_id