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
- Registration Number
- NCT01714466
- Lead Sponsor
- Norgine
- Brief Summary
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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The subject's written informed consent must be obtained prior to inclusion.
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Subjects age 40 to 70 years.
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Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject:
- is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or
- is aged 55 to 70.
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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.
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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).
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Willing, able and competent to complete the entire procedure and to comply with study instructions.
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Ferrous sulphate should be stopped at least one week prior to study medication.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B, arm 3 NER1006 IMP as used in Part B, arm 1, except for a reduced amount of ascorbate Part A, arm 4 MOVIPREP MOVIPREP (Both evening and morning dose) Part A, arm 2 NER1006 Evening dose of TF043. Morning dose of TF048 Part A, arm 3 NER1006 Evening dose of TF047. Morning dose of TF043 Part A, arm 1 NER1006 Evening dose of TF048. Morning dose of TF043 Part B, arm 4 MOVIPREP MOVIPREP used in both evening and morning dose Part B, arm 2 NER1006 IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed Part B, arm 1 NER1006 IMP selected based on the optimal dosing sequence and volume identified from Part A
- Primary Outcome Measures
Name Time Method Stool weight output 36 hours post-dose 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 36 hours post-dose The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)
- Secondary Outcome Measures
Name Time Method Tolerability of medication (vomiting rate) 36 hours post-dose 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) 36 hours post-dose Patients to use the EQ 5D patient questionnaire to assess their study medication for part A
Ascorbate concentration 36 hours post-dose Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)
Cleansing scores for each colon segment 36 hours post-dose The segmental cleansing scores for each of the five colon segments
Time and volume of IMP to reach a clear effluent 36 hours post-dose The time and volume taken for the IMP to reach a clear effluent
Electrolytes concentration 36 hours post-dose Concentration of electrolytes in blood, urine and faeces
PEG3350 concentration 36 hours post-dose Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities
Trial Locations
- Locations (2)
PAREXEL International Early Product Development Unit
🇩🇪Berlin, Germany
Parexel International GmbH
🇩🇪Berlin, Germany