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

This study is currently recruiting participants.
Verified April 2013 by Norgine
Information provided by (Responsible Party):
Norgine Identifier:
First received: October 19, 2012
Last updated: April 8, 2013
Last verified: April 2013

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

Condition Intervention Phase
Colon Cancer
Drug: NER1006
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Norgine:

Primary Outcome Measures:
  • Stool weight output [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours

  • Cleansing success rate [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)

Secondary Outcome Measures:
  • Tolerability of medication (vomiting rate) [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B

  • EQ 5D patient questionnaire outcome (Part A only) [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    Patients to use the EQ 5D patient questionnaire to assess their study medication for part A

  • Cleansing scores for each colon segment [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    The segmental cleansing scores for each of the five colon segments

  • Time and volume of IMP to reach a clear effluent [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    The time and volume taken for the IMP to reach a clear effluent

  • Ascorbate concentration [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)

  • Electrolytes concentration [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    Concentration of electrolytes in blood, urine and faeces

  • PEG3350 concentration [ Time Frame: 36 hours post-dose ] [ Designated as safety issue: No ]
    Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities

Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A, arm 1
Evening dose of TF048. Morning dose of TF043
Drug: NER1006
Experimental: Part A, arm 2
Evening dose of TF043. Morning dose of TF048
Drug: NER1006
Experimental: Part A, arm 3
Evening dose of TF047. Morning dose of TF043
Drug: NER1006
Active Comparator: Part A, arm 4
MOVIPREP (Both evening and morning dose)
Experimental: Part B, arm 1
IMP selected based on the optimal dosing sequence and volume identified from Part A
Drug: NER1006
Experimental: Part B, arm 2
IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed
Drug: NER1006
Active Comparator: Part B, arm 3
IMP as used in Part B, arm 1, except for a reduced amount of ascorbate
Drug: NER1006
Experimental: Part B, arm 4
MOVIPREP used in both evening and morning dose


Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01714466

Contact: Caroline Bay +44189545 ext 3689

Parexel International GmbH Not yet recruiting
Berlin, Germany, 14050
PAREXEL International Early Product Development Unit Recruiting
Berlin, Germany, 14050
Contact: Rudiger Kornberger, MD    +49 30 30685 3900      
Sponsors and Collaborators
Principal Investigator: Rudiger Kornberger, MD PAREXEL International GmbH
  More Information

No publications provided

Responsible Party: Norgine Identifier: NCT01714466     History of Changes
Other Study ID Numbers: NER1006-01/2012 (OPT)
Study First Received: October 19, 2012
Last Updated: April 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases processed this record on April 14, 2014