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. (see Contacts and Locations)
Verified April 2013 by Norgine
Sponsor:
Information provided by (Responsible Party):
Norgine
ClinicalTrials.gov Identifier:
NCT01714466
First received: October 19, 2012
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Colon Cancer
Drug: NER1006
Drug: MOVIPREP
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)
Drug: MOVIPREP
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
Drug: MOVIPREP

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714466

Contacts
Contact: Caroline Bay +44189545 ext 3689 CBay@norgine.com

Locations
Germany
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
Norgine
Investigators
Principal Investigator: Rudiger Kornberger, MD PAREXEL International GmbH
  More Information

No publications provided

Responsible Party: Norgine
ClinicalTrials.gov 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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014