Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults.

NCT ID: NCT02273141

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-08-31

Brief Summary

This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen. Approximately 484 patients will be randomised with the aim of achieving a minimum of 220 patients in each of the 2 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, Day Before-Only Dosing

NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).

Group Type: EXPERIMENTAL

NER1006, Day Before-Only Dosing

Intervention Type: DRUG

The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose.

SP+MS, Day Before-Only Dosing

SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).

Group Type: ACTIVE_COMPARATOR

SP+MS, Day Before-Only Dosing

Intervention Type: DRUG

The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.

Interventions

NER1006, Day Before-Only Dosing

The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose.

Intervention Type: DRUG

SP+MS, Day Before-Only Dosing

The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.

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, able and competent 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), sodium picosulfate and magnesium salt compounds, 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 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 are ordered to live in an institution on court or authority order.
• Patients with history of rhabdomyolysis

• 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

Stefan Schreiber

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

Charité - Campus Virchow Klinikum

Berlin, , Germany

University Hospital Schleswig-Holstein

Kiel, , Germany

An der Germania Brauerei 6

Münster, , Germany

An der Germania Brauerei 6

Milan, , Italy

Osp.San Raffaele U.O. Gastroenterologia

Milan, , Italy

P.T.P.Nuovo Regina Margherita

Rome, , Italy

Onze Lieve Vrouwe Gashuis

Amsterdam, , Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Radboud UMC

Nijmegen, , Netherlands

Orbis Medisch Centrum

Sittard, , Netherlands

Centrum Medyczne sw. Lukasza

Częstochowa, , Poland

Instytut Medycyny Wsi im. Witolda Chodzki w

Lubliniec, , Poland

Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

Sopot, , Poland

SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego

Szczecin, , Poland

Hospital de Vinalopó, Unidad de Endoscopia Digestiva

Elche, , Spain

Hospital Universitario de la Princesa

Madrid, , Spain

Hospital Universitario La Paz, Unidad Enfermedad Intestinal

Madrid, , Spain

Department of Surgery, Raigmore Hospital

Inverness, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Countries

Germany; Italy; Netherlands; 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)

Other Identifiers

NER1006-03/2014 (DAYB)

Identifier Type: -

Identifier Source: org_study_id