Clinical trial NCT02273167: 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.
Official title: 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 MOVIPREP Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Colorectal Carcinoma
Colon Cleansing
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2014-10-23
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Number of Patients With Successful Bowel Cleansing (Overall Colon)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary outcomes:
measure: Adenoma Detection Rate (Colon Ascendens)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Adenoma Detection Rate (Overall Colon)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Polyp Detection Rate (Colon Ascendens)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Polyp Detection Rate (Overall Colon)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Ghent
country: Belgium
facility: UZ Ghent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC- Clinique Saint-Joseph
city: Bobigny
country: France
facility: Hôpital Avicenne- Service de Gastro-Entérologie
city: Nantes
country: France
facility: Hôpital Hotel-Dieu
city: Essen
country: Germany
facility: Kliniken Essen-Mitte; Abteilung für Gastroenterologie
city: Jena
country: Germany
facility: Klinikum der Friedrich Schiller Universität Jena
city: Ludwigshafen
country: Germany
facility: Praxis für Innere Medizin, Gastroenterologie und Allg. Medizin
city: Bologna
country: Italy
facility: A.O.U. di Bologna - Policlinico S. Orsola-Malpighi
city: Como
country: Italy
facility: Ospedale Valduce U.O. Gastroenterologia e Endoscopia
city: Naples
country: Italy
facility: P.O. Maresca OORR Area Vesuviana ASL
city: Pordenone
country: Italy
facility: Centro di Riferimento Oncologico (C.R.O.) S.O.C Gastroenterologia
city: Roma
country: Italy
facility: Pol. Univ. A. Gemelli U.O. di Endoscopia Digestiva Chirurgica
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Czestochowa
country: Poland
facility: Gabinet Internistyczny dr n. med. Krzysztof Janik
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
city: Warsaw
country: Poland
facility: Robert Petryka Gabinet Internistyczny
city: Wrocław
country: Poland
facility: Lexmedica Durbajlo Hanna
city: Łódź
country: Poland
facility: NZOZ Centrum Medyczne-Szpital Swietej Rodziny
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal - Ctra. De Colmenar km. 9, 100
city: Edinburgh
country: United Kingdom
facility: Lothian Health Board
city: Melrose
country: United Kingdom
facility: Borders General Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary Department
Study officials:
affiliation: UZ Leuven
name: Raf Bisschops, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.