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
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 |
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | PAREXEL International Early Product Development Unit | Berlin | |
Germany | Parexel International GmbH | Berlin |
Lead Sponsor | Collaborator |
---|---|
Norgine |
Germany,
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 |
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