Clinical trial NCT01714466: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Stool weight output
timeFrame: 36 hours post-dose
measure: Cleansing success rate
timeFrame: 36 hours post-dose
Secondary outcomes:
measure: Tolerability of medication (vomiting rate)
timeFrame: 36 hours post-dose
measure: EQ 5D patient questionnaire outcome (Part A only)
timeFrame: 36 hours post-dose
measure: Cleansing scores for each colon segment
timeFrame: 36 hours post-dose
measure: Time and volume of IMP to reach a clear effluent
timeFrame: 36 hours post-dose
measure: Ascorbate concentration
timeFrame: 36 hours post-dose
measure: Electrolytes concentration
timeFrame: 36 hours post-dose
measure: PEG3350 concentration
timeFrame: 36 hours post-dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: PAREXEL International Early Product Development Unit
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Parexel
name: Rudiger Kornberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.