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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714466
• Other study ID #: NER1006-01/2012 (OPT)
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2012
• Last updated: November 19, 2014
• Start date: October 2012
• Est. completion date: January 2014

Study information

• Verified date: November 2014
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Drug:
• NER1006

• MOVIPREP

Locations

Country	Name	City	State
Germany	PAREXEL International Early Product Development Unit	Berlin
Germany	Parexel International GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool weight output	Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours	36 hours post-dose	No
Primary	Cleansing success rate	The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)	36 hours post-dose	No
Secondary	Tolerability of medication (vomiting rate)	The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B	36 hours post-dose	No
Secondary	EQ 5D patient questionnaire outcome (Part A only)	Patients to use the EQ 5D patient questionnaire to assess their study medication for part A	36 hours post-dose	No
Secondary	Cleansing scores for each colon segment	The segmental cleansing scores for each of the five colon segments	36 hours post-dose	No
Secondary	Time and volume of IMP to reach a clear effluent	The time and volume taken for the IMP to reach a clear effluent	36 hours post-dose	No
Secondary	Ascorbate concentration	Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)	36 hours post-dose	No
Secondary	Electrolytes concentration	Concentration of electrolytes in blood, urine and faeces	36 hours post-dose	No
Secondary	PEG3350 concentration	Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities	36 hours post-dose	No