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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

Phase 2
40 Years
70 Years
Open (Enrolling)
Colon Cancer

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Trial Information

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

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

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

- 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

- 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

- 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

- Previous participation in the study.

- Persons who are ordered to live in an institution on court or authority order

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Stool weight output

Outcome Description:

Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours

Outcome Time Frame:

36 hours post-dose

Safety Issue:


Principal Investigator

Rudiger Kornberger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

PAREXEL International GmbH


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NER1006-01/2012 (OPT)



Start Date:

October 2012

Completion Date:

September 2013

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms