Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.

NCT ID: NCT02273167

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 849 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-08-31

Brief Summary

This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens. Approximately 810 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 3 groups.

Conditions

Colorectal 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 colonoscopy).

Group Type: EXPERIMENTAL

NER1006, 2-Day Split-Dosing

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.

NER1006,1-Day Morning Split-Dosing

NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).

Group Type: EXPERIMENTAL

NER1006,1-Day Morning Split-Dosing

Intervention Type: DRUG

The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid.

After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid.

MOVIPREP, 2-Day Split-Dosing

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

Group Type: ACTIVE_COMPARATOR

MOVIPREP, 2-Day Split-Dosing

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 recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.

Interventions

NER1006, 2-Day Split-Dosing

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

NER1006,1-Day Morning Split-Dosing

The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid.

After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid.

Intervention Type: DRUG

MOVIPREP, 2-Day Split-Dosing

The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must provide 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 (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): 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 and able to complete the entire study and to 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.
• 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 study drug 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 severe renal insufficiency (i.e. with GFR, <30 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 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

Raf Bisschops, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

AZ Sint-Lucas

Bruges, , Belgium

UZ Ghent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

CHC- Clinique Saint-Joseph

Liège, , Belgium

Hôpital Avicenne- Service de Gastro-Entérologie

Bobigny, , France

Hôpital Hotel-Dieu

Nantes, , France

Kliniken Essen-Mitte; Abteilung für Gastroenterologie

Essen, , Germany

Klinikum der Friedrich Schiller Universität Jena

Jena, , Germany

Praxis für Innere Medizin, Gastroenterologie und Allg. Medizin

Ludwigshafen, , Germany

A.O.U. di Bologna - Policlinico S. Orsola-Malpighi

Bologna, , Italy

Ospedale Valduce U.O. Gastroenterologia e Endoscopia

Como, , Italy

P.O. Maresca OORR Area Vesuviana ASL

Naples, , Italy

Centro di Riferimento Oncologico (C.R.O.) S.O.C Gastroenterologia

Pordenone, , Italy

Pol. Univ. A. Gemelli U.O. di Endoscopia Digestiva Chirurgica

Roma, , Italy

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, , Poland

Gabinet Internistyczny dr n. med. Krzysztof Janik

Częstochowa, , Poland

NZOZ Centrum Medyczne-Szpital Swietej Rodziny

Lodz, , Poland

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych

Warsaw, , Poland

Robert Petryka Gabinet Internistyczny

Warsaw, , Poland

Lexmedica Durbajlo Hanna

Wroclaw, , Poland

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Ramon y Cajal - Ctra. De Colmenar km. 9, 100

Madrid, , Spain

Lothian Health Board

Edinburgh, , United Kingdom

Borders General Hospital

Melrose, , United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

Royal Albert Edward Infirmary Department

Wigan, , United Kingdom

Countries

Belgium; France; Germany; Italy; Poland; Spain; United Kingdom

References

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)

Bisschops R, Manning J, Clayton LB, Ng Kwet Shing R, Alvarez-Gonzalez M; MORA Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):60-72. doi: 10.1055/a-0638-8125. Epub 2018 Jul 19.

Reference Type: DERIVED

PMID: 30025414 (View on PubMed)

Other Identifiers

NER1006-02/2014 (MORA)

Identifier Type: -

Identifier Source: org_study_id