Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT01714466
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2012-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520497', 'term': 'MoviPrep'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2012-10-19', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool weight output', 'timeFrame': '36 hours post-dose', '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'}, {'measure': 'Cleansing success rate', 'timeFrame': '36 hours post-dose', 'description': 'The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)'}], 'secondaryOutcomes': [{'measure': 'Tolerability of medication (vomiting rate)', 'timeFrame': '36 hours post-dose', 'description': "The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B"}, {'measure': 'EQ 5D patient questionnaire outcome (Part A only)', 'timeFrame': '36 hours post-dose', 'description': 'Patients to use the EQ 5D patient questionnaire to assess their study medication for part A'}, {'measure': 'Cleansing scores for each colon segment', 'timeFrame': '36 hours post-dose', 'description': 'The segmental cleansing scores for each of the five colon segments'}, {'measure': 'Time and volume of IMP to reach a clear effluent', 'timeFrame': '36 hours post-dose', 'description': 'The time and volume taken for the IMP to reach a clear effluent'}, {'measure': 'Ascorbate concentration', 'timeFrame': '36 hours post-dose', 'description': 'Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)'}, {'measure': 'Electrolytes concentration', 'timeFrame': '36 hours post-dose', 'description': 'Concentration of electrolytes in blood, urine and faeces'}, {'measure': 'PEG3350 concentration', 'timeFrame': '36 hours post-dose', 'description': 'Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '31146679', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject's written informed consent must be obtained prior to inclusion.\n* Subjects age 40 to 70 years.\n* Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject:\n\n 1. is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or\n 2. is aged 55 to 70.\n* 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.\n* 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).\n* Willing, able and competent to complete the entire procedure and to comply with study instructions.\n* Ferrous sulphate should be stopped at least one week prior to study medication.\n\nExclusion Criteria:\n\n* Part A only: Subjects undergoing screening colonoscopy.\n* Presence of current clinically significant functional gastrointestinal (GI) disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome \\[IBS\\]).\n* Regular use of laxatives or colon motility altering drugs in the last month.\n* Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.\n* Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.\n* Known glucose-6-phosphatase dehydrogenase deficiency.\n* Known phenylketonuria.\n* History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.\n* Known hypersensitivity to polyethylene glycols and/or ascorbic acid.\n* History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.\n* Evidence of dehydration.\n* Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances.\n* Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal.\n* Clinically relevant findings on physical examination based on the Investigator's judgement.\n* Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.\n* Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.\n* 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.\n* Subjects who are unwilling to comply with the provisions of the study protocol.\n* Concurrent participation in an investigational drug study or participation within 3 months of study entry.\n* 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.\n* Previous participation in the study.\n* Persons who are ordered to live in an institution on court or authority order"}, 'identificationModule': {'nctId': 'NCT01714466', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Norgine'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NER1006-01/2012 (OPT)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, arm 1', 'description': 'Evening dose of TF048. Morning dose of TF043', 'interventionNames': ['Drug: NER1006']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, arm 2', 'description': 'Evening dose of TF043. Morning dose of TF048', 'interventionNames': ['Drug: NER1006']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, arm 3', 'description': 'Evening dose of TF047. Morning dose of TF043', 'interventionNames': ['Drug: NER1006']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part A, arm 4', 'description': 'MOVIPREP (Both evening and morning dose)', 'interventionNames': ['Drug: MOVIPREP']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, arm 1', 'description': 'IMP selected based on the optimal dosing sequence and volume identified from Part A', 'interventionNames': ['Drug: NER1006']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, arm 2', 'description': 'IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed', 'interventionNames': ['Drug: NER1006']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B, arm 3', 'description': 'IMP as used in Part B, arm 1, except for a reduced amount of ascorbate', 'interventionNames': ['Drug: NER1006']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, arm 4', 'description': 'MOVIPREP used in both evening and morning dose', 'interventionNames': ['Drug: MOVIPREP']}], 'interventions': [{'name': 'NER1006', 'type': 'DRUG', 'armGroupLabels': ['Part A, arm 1', 'Part A, arm 2', 'Part A, arm 3', 'Part B, arm 1', 'Part B, arm 2', 'Part B, arm 3']}, {'name': 'MOVIPREP', 'type': 'DRUG', 'armGroupLabels': ['Part A, arm 4', 'Part B, arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'PAREXEL International Early Product Development Unit', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Parexel International GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Rudiger Kornberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norgine', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}