Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT01478620
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2011-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ivanovdd@i.kiev.ua', 'phone': '+38 (039) 247 12 36', 'title': 'Ivanov, Dmitry', 'organization': '"Kiev regional City Hospital"'}, 'certainAgreement': {'otherDetails': 'Each Party acknowledges that it shall not publish any results of the trial,without the prior written authorization of the other Party. If SPONSOR (S.) requests INVESTIGATOR (I.)to publish any results obtained from the study, I. shall prepare and accomplish such publication at the expense of S. after review by S. and subject to written approval of the S. prior to publication. I. must be mentioned as co-author in any kind of publication resulting from such a request by S. to I. to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Canephron® N', 'description': '3x 2 coated tablets/day for 7 days p.o.', 'otherNumAtRisk': 125, 'otherNumAffected': 11, 'seriousNumAtRisk': 125, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Heart rate irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Canephron® N', 'description': '3x 2 coated tablets/day for 7 days p.o.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During active treatment period (day 1 until day 7)', 'description': 'No study drug related adverse drug reactions were registered.', 'unitOfMeasure': 'Adverse Drug Reactions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days', 'timeFrame': 'During active treatment period', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)', 'timeFrame': 'Day 7', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Severity of uUTI Symptoms on Day 7', 'timeFrame': 'Day 7', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Severity of uUTI Symptoms on Day 37', 'timeFrame': 'Day 37', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Duration of uUTI Symptoms', 'timeFrame': 'During active treatment and follow up period (Day 0 - Day 37)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Require Antibiotic Treatment Until Day 7', 'timeFrame': 'During active treatment period', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms', 'timeFrame': 'During active treatment and follow up period (Day 0 - Day 37)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms', 'timeFrame': 'During active treatment and follow up period (Day 0 - Day 37)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canephron® N', 'description': '3x 2 coated tablets/day for 7 days p.o.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Canephron® N', 'description': '3x 2 coated tablets/day for 7 days p.o.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'female participants', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ukraine', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'uncomplicated urinary tract infection symptom score', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '1.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The severity of uUTI symptoms was assessed daily by the patient as well as by the investigator at each study visit. The following uUTI symptoms were rated on a 5-point scale: dysuria, frequency, urgency, acute development of incontinence or worsening of incontinence, nocturia, pain or discomfort in lower abdomen or pelvic areas and increased body temperature.\n\nThe assessment of the symptoms ranged from 0 (absent or \\</= 37°C) to 4 (very severe or \\>/= 40°C).\n\nAt baseline the total sum score (sum of subscales) of the symptoms dysuria, frequency and urgency had to be at least \\>/= 6.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2011-11-21', 'resultsFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-10', 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N', 'timeFrame': 'During active treatment period (day 1 until day 7)', 'description': 'No study drug related adverse drug reactions were registered.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days', 'timeFrame': 'During active treatment period'}, {'measure': 'Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)', 'timeFrame': 'Day 7'}, {'measure': 'Severity of uUTI Symptoms on Day 7', 'timeFrame': 'Day 7'}, {'measure': 'Severity of uUTI Symptoms on Day 37', 'timeFrame': 'Day 37'}, {'measure': 'Duration of uUTI Symptoms', 'timeFrame': 'During active treatment and follow up period (Day 0 - Day 37)'}, {'measure': 'Proportion of Patients Who Require Antibiotic Treatment Until Day 7', 'timeFrame': 'During active treatment period'}, {'measure': 'Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms', 'timeFrame': 'During active treatment and follow up period (Day 0 - Day 37)'}, {'measure': 'Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms', 'timeFrame': 'During active treatment and follow up period (Day 0 - Day 37)'}]}, 'conditionsModule': {'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess safety and impact of a non-antibiotic therapy approach with Canephron® N in the management strategy of uncomplicated lower urinary tract infections (UTIs).', 'detailedDescription': '250 patients total 7-day treatment period with Canephron® N (2 tablets three times a day) and a follow-up period until Day 37. A total of three visits are planned on Day 0 (screening, start of study treatment), Day 7 (end of study treatment) and Day 37 (end of study visit).\n\nAdditional visits can be performed anytime between Day 1 and Day 37 if deemed necessary by the investigator. In case the patients experience consistent or worsening of symptoms they may be offered antibiotic therapy at the discretion of the investigator at any time. In this case Canephron® N intake will be stopped.\n\nAt least 50% of the patients, i.e. 125 subjects, should have received a 7-day treatment with Canephron® N. If less subjects are available recruitment of subjects will be continued until the required number of 125 subjects is reached.\n\nDue to withdrawal of study in Russia total study population was reduced to 125 patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Female outpatients aged 18-65 years (both inclusive).\n* Patients suffering of symptoms of uncomplicated lower urinary infection at screening. Patients must have a total sum score of at least six for the symptoms dysuria, frequency and urgency.\n* Development of symptoms within a maximum of 6 days before screening.\n* Willing to refrain from consuming prohibited concomitant medications and products.\n* Non-lactating female patients, who are surgically sterile (have had a documented bilateral oophorectomy and/or hysterectomy) or postmenopausal (cessation of menses for more than 1 year), or patients of childbearing potential with a negative pregnancy test at screening willing to use effective contraception methods (intrauterine device \\[IUD\\], hormonal contraceptives) during the study.\n\nMain Exclusion Criteria:\n\n* Any signs evoking complicated UTI, pyelonephritis and/or concomitant vulvo-vaginitis\n* Any conditions that may lead to complicated infections (that is, renal diseases, urinary tract abnormalities or past urinary surgery, urine catheterization, etc).\n* Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy.\n* Current signs or symptoms of severe, progressive or uncontrolled life-threatening systemic disease i.e. renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.\n* Other acute infection (except UTI) requiring antibiotic treatment.\n* Patients receiving treatment for presumed or proven urinary tract infection within 4 weeks prior to study entry.\n* Antibiotic, immunosuppressive or immunostimulant (incl. vaccines) therapy within 4 weeks prior to study entry.\n* Patients with known history of anatomical genitourinary (GU) anomalies or GU surgery within 6 months prior to study entry.\n* Patients with known clinically significant abnormalities in screening physical examination, laboratory tests or vital signs.\n* Peptic ulcers and hypersensitivity and/or idiosyncrasy to centaury herb, lovage root, rosemary leaves or one of the other ingredients of the investigational medicinal product.\n* Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, galactose intolerance or lactase deficiency.\n* Patients with a history of severe drug allergy or hypersensitivity.\n* Known Human Immunodeficiency Virus (HIV)-seropositivity.'}, 'identificationModule': {'nctId': 'NCT01478620', 'briefTitle': 'Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bionorica SE'}, 'officialTitle': 'An Open-label, Non-randomized, Multicenter, Interventional Study to Investigate the Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)', 'orgStudyIdInfo': {'id': 'CanUTI2'}, 'secondaryIdInfos': [{'id': '2011-000838-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canephron® N', 'interventionNames': ['Drug: Canephron® N']}], 'interventions': [{'name': 'Canephron® N', 'type': 'DRUG', 'description': '3x 2 coated tablets/day for 7 days p.o.', 'armGroupLabels': ['Canephron® N']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04107', 'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Kiev Regional City Hospital', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Dmitry Ivanov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kiev regional city hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bionorica SE', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}