Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-29 @ 3:22 AM
Study NCT ID:
NCT01674192
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2012-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prucalopride Subjects With Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-07'}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '1999-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2012-08-24', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement'}]}, 'conditionsModule': {'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '23269861', 'type': 'DERIVED', 'citation': 'Smith WB, Mannaert E, Verhaeghe T, Kerstens R, Vandeplassche L, Van de Velde V. Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study. Drug Des Devel Ther. 2012;6:407-15. doi: 10.2147/DDDT.S36142. Epub 2012 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of prucalopride in subjects with various degrees of renal impairment compared with normal renal function and to monitor the safety profile of prucalopride in subjects with renal impairment.\n\nHypothesis:\n\nPrucalopride might accumulate and exhibit a different pharmacokinetic profile in renally impaired subjects compared with the normal population.', 'detailedDescription': 'This is a single-centre, open label, single-dose, pharmacokinetic trial with prucalopride in subjects with varying degrees of renal impairment. Subjects were classified into one of four renal function groups, as defined by a 24-hour creatinine clearance determination (CRCL) obtained within 2 weeks before trial entry. Each subject was administered a single 2mg oral dose of prucalopride. Plasma samples and complete urine collections were obtained from 0 through 120 h (6 days) after dosing to characterize the pharmacokinetics of prucalopride.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects had to meet the following inclusion criteria:\n\n* Between the ages of 18 and 75 years, inclusive;\n* Males or females. Females were to be of non-childbearing potential.\n\nNormal subjects had to meet the following additional inclusion criteria:\n\n* Demographically comparable to the subjects with renal impairment, within 30% of mean weight and height and 10% of the mean age;\n* Physical examination, clinical laboratory results, and 12-lead ECG within normal limits at screening;\n* No intake of medication, including over-the-counter medication, during a pre-trial 7-day drug-free washout period;\n\nSubjects with renal impairment had to meet the following additional inclusion criteria:\n\n* Stable severity of renal disease;\n* Concomitant medications to treat underlying disease states or medical conditions related to renal insufficiency were allowed;\n* Stable dose of medication and/or treatment regimen from 2 months prior to and during the trial;\n* Subjects with stable cardiovascular disease could be enrolled, provided that the investigator felt their condition would not interfere with the results of the trial.\n\nExclusion Criteria:\n\nAll subjects who met any of the following criteria were excluded from the trial:\n\n* History of hypersensitivity to prucalopride or inactive ingredients in the prucalopride capsule or to related prokinetic compounds;\n* Use of any other investigational drug within 30 days prior to signing the consent or intention to take any investigational drug during the trial;\n* History of significant blood loss, or blood plasma donation (500mL) within the last 30 days;\n* Pregnancy or breast feeding;\n* Gastrointestinal (GI) surgery within 3 months, or history of major GI surgery with potential compromise of drug absorption or metabolism;\n\nNormal subjects who met any of the following criteria were excluded from the trial:\n\n* Any abnormal medical history, physical examination, ECG, or laboratory results;\n* Use of medications 7 days prior to and during the trial.\n* Subjects with renal impairment who met any of the following criteria were excluded from the trial.\n* Any abnormality in medical history, physical examination, ECG, or laboratory results that, in the opinion of the investigator, might affect the safety of the subject;\n* History of uric acid stone disease, uricosuria, or gout, or current hyperuricemia;\n* Renal transplants, lupus erythematosus, or renal carcinoma.'}, 'identificationModule': {'nctId': 'NCT01674192', 'briefTitle': 'Prucalopride Subjects With Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Movetis'}, 'officialTitle': 'Single Dose Pharmacokinetic Trial of Oral Prucalopride (R093877) in Subjects With Mild, Moderate and Severe Renal Impairment', 'orgStudyIdInfo': {'id': 'PRU-USA-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prucalopride', 'description': 'single dose of 2 mg prucalopride', 'interventionNames': ['Drug: prucalopride']}], 'interventions': [{'name': 'prucalopride', 'type': 'DRUG', 'description': 'single dose of 2 mg prucalopride', 'armGroupLabels': ['prucalopride']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'W. Smith, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Movetis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}