Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy

NCT ID: NCT01714466

Last Updated: 2014-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-01-31

Brief Summary

A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A, arm 1

Evening dose of TF048. Morning dose of TF043

Group Type: EXPERIMENTAL

NER1006

Intervention Type: DRUG

Part A, arm 2

Evening dose of TF043. Morning dose of TF048

Group Type: EXPERIMENTAL

NER1006

Intervention Type: DRUG

Part A, arm 3

Evening dose of TF047. Morning dose of TF043

Group Type: EXPERIMENTAL

NER1006

Intervention Type: DRUG

Part A, arm 4

MOVIPREP (Both evening and morning dose)

Group Type: ACTIVE_COMPARATOR

MOVIPREP

Intervention Type: DRUG

Part B, arm 1

IMP selected based on the optimal dosing sequence and volume identified from Part A

Group Type: EXPERIMENTAL

NER1006

Intervention Type: DRUG

Part B, arm 2

IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed

Group Type: EXPERIMENTAL

NER1006

Intervention Type: DRUG

Part B, arm 3

IMP as used in Part B, arm 1, except for a reduced amount of ascorbate

Group Type: ACTIVE_COMPARATOR

NER1006

Intervention Type: DRUG

Part B, arm 4

MOVIPREP used in both evening and morning dose

Group Type: EXPERIMENTAL

MOVIPREP

Intervention Type: DRUG

Interventions

NER1006

Intervention Type: DRUG

MOVIPREP

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subject's written informed consent must be obtained prior to inclusion.
• Subjects age 40 to 70 years.
• Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject:

1. is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or

2. is aged 55 to 70.

• Part A: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
• Females of child bearing potential must be surgically sterile, post- menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in (unless post-menopausal).
• Willing, able and competent to complete the entire procedure and to comply with study instructions.
• Ferrous sulphate should be stopped at least one week prior to study medication.

Exclusion Criteria

• Part A only: Subjects undergoing screening colonoscopy.
• Presence of current clinically significant functional gastrointestinal (GI) disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome [IBS]).
• Regular use of laxatives or colon motility altering drugs in the last month.
• Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
• Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
• Known glucose-6-phosphatase dehydrogenase deficiency.
• Known phenylketonuria.
• History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.
• Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
• History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.
• Evidence of dehydration.
• Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances.
• Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal.
• Clinically relevant findings on physical examination based on the Investigator's judgement.
• Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
• Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
• History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
• Subjects who are unwilling to comply with the provisions of the study protocol.
• Concurrent participation in an investigational drug study or participation within 3 months of study entry.
• Subject has a condition or is in a situation, which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
• Previous participation in the study.
• Persons who are ordered to live in an institution on court or authority order

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rudiger Kornberger, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

PAREXEL International Early Product Development Unit

Berlin, , Germany

Parexel International GmbH

Berlin, , Germany

Countries

Germany

References

Clayton LB, Tayo B, Halphen M, Kornberger R. Novel 1 L polyethylene glycol-based bowel preparation (NER1006): proof of concept assessment versus standard 2 L polyethylene glycol with ascorbate - a randomized, parallel group, phase 2, colonoscopist-blinded trial. BMC Gastroenterol. 2019 May 30;19(1):79. doi: 10.1186/s12876-019-0988-y.

Reference Type: DERIVED

PMID: 31146679 (View on PubMed)

Other Identifiers

NER1006-01/2012 (OPT)

Identifier Type: -

Identifier Source: org_study_id