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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

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ClinicalTrials.gov Identifier: NCT01714466
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : November 20, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: NER1006 Drug: MOVIPREP Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2012
Primary Completion Date : July 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Stool weight output [ Time Frame: 36 hours post-dose ]
    Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours

  2. Cleansing success rate [ Time Frame: 36 hours post-dose ]
    The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)

Secondary Outcome Measures :
  1. Tolerability of medication (vomiting rate) [ Time Frame: 36 hours post-dose ]
    The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B

  2. EQ 5D patient questionnaire outcome (Part A only) [ Time Frame: 36 hours post-dose ]
    Patients to use the EQ 5D patient questionnaire to assess their study medication for part A

  3. Cleansing scores for each colon segment [ Time Frame: 36 hours post-dose ]
    The segmental cleansing scores for each of the five colon segments

  4. Time and volume of IMP to reach a clear effluent [ Time Frame: 36 hours post-dose ]
    The time and volume taken for the IMP to reach a clear effluent

  5. Ascorbate concentration [ Time Frame: 36 hours post-dose ]
    Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)

  6. Electrolytes concentration [ Time Frame: 36 hours post-dose ]
    Concentration of electrolytes in blood, urine and faeces

  7. PEG3350 concentration [ Time Frame: 36 hours post-dose ]
    Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714466

PAREXEL International Early Product Development Unit
Berlin, Germany, 14050
Parexel International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
Principal Investigator: Rudiger Kornberger, MD Parexel
More Information

Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT01714466     History of Changes
Other Study ID Numbers: NER1006-01/2012 (OPT)
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014