Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-24 @ 5:26 PM
Study NCT ID:
NCT03357666
Status:
UNKNOWN
Last Update Posted:
2017-12-02
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment', 'timeFrame': 'at 2 weeks after last treatment'}], 'secondaryOutcomes': [{'measure': 'Therapeutic cure rate of bacterial vaginosis at last treatment', 'timeFrame': 'at 7 days'}, {'measure': 'proportion of patients with Normal Nugent score', 'timeFrame': 'at 2 weeks after last treatment'}, {'measure': 'proportion of patients with Normal Hay/Ison grade', 'timeFrame': 'at 2 weeks after last treatment'}, {'measure': 'proportion of patients with Normal Vaginal Fluid pH', 'timeFrame': 'at 2 weeks after last treatment'}]}, 'conditionsModule': {'conditions': ['Bacterial Vaginosis', 'HUDC_VT', 'Haudongchun']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after HUDC-VT administration compared to placebo in patients with bacterial vaginosis.\n\nVaginitis in adult women is extremely common and it often results in marked suffering. Epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in US.\n\nThe broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.However, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus.\n\nIn addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina.\n\nThe product, HUDC\\_VT, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fertile women\n2. Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria)\n\n * light gray adherent vaginal discharge\n * pH \\>4.5\n * Presence of clue cells ≥20%\n * Positive "10% KOH whiff test"\n3. Nugent Score ≥ 4\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding patient or planning pregnancy\n2. Patient with candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex virus infection\n3. Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization\n4. Any condition or circumstance that would interfere with analysis of study results\n5. Patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period'}, 'identificationModule': {'nctId': 'NCT03357666', 'briefTitle': 'Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haudongchun Co., Ltd.'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Parallel Design, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of HUDC_VT in Patients With Bacterial Vaginosis', 'orgStudyIdInfo': {'id': 'HUDC-VT-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HUDC_VT(Glucose 200mg/Sodium chloride 200mg)', 'description': 'Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days', 'interventionNames': ['Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg)']}, {'type': 'EXPERIMENTAL', 'label': 'HUDC_VT(Glucose 400mg/Sodium chloride 200mg)', 'description': 'Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days', 'interventionNames': ['Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg)']}, {'type': 'EXPERIMENTAL', 'label': 'HUDC_VT(Glucose 400mg)', 'description': 'Glucose 400mg, once a day, two tablets at a time for 7 days', 'interventionNames': ['Drug: HUDC_VT (Glucose 400mg)']}, {'type': 'EXPERIMENTAL', 'label': 'HUDC_VT(Sodium chloride 200mg)', 'description': 'Sodium chloride 200mg, once a day, two tablets at a time for 7 days', 'interventionNames': ['Drug: HUDC_VT (Sodium chloride 200mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, once a day, two tablets at a time for 7 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HUDC_VT(Glucose 200mg/Sodium chloride 200mg)', 'type': 'DRUG', 'description': 'Vaginal administration, two tablets once a day for 7 days', 'armGroupLabels': ['HUDC_VT(Glucose 200mg/Sodium chloride 200mg)']}, {'name': 'HUDC_VT (Glucose 400mg/Sodium chloride 200mg)', 'type': 'DRUG', 'description': 'Vaginal administration, two tablets once a day for 7 days', 'armGroupLabels': ['HUDC_VT(Glucose 400mg/Sodium chloride 200mg)']}, {'name': 'HUDC_VT (Glucose 400mg)', 'type': 'DRUG', 'description': 'Vaginal administration, two tablets once a day for 7 days', 'armGroupLabels': ['HUDC_VT(Glucose 400mg)']}, {'name': 'HUDC_VT (Sodium chloride 200mg)', 'type': 'DRUG', 'description': 'Vaginal administration, two tablets once a day for 7 days', 'armGroupLabels': ['HUDC_VT(Sodium chloride 200mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vaginal administration, two tablets once a day for 7 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'state': 'Guro-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JaeKwan Lee', 'role': 'CONTACT', 'email': 'jklee38@korea.ac.kr', 'phone': '+82 2-2626-1200'}, {'name': 'JaeKwan Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'MiYeon Choi', 'role': 'CONTACT', 'email': 'cbg@hudc.co.kr', 'phone': '+82 70-7729-5704'}], 'overallOfficials': [{'name': 'WonSeog Choi', 'role': 'STUDY_CHAIR', 'affiliation': 'Haudongchun Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haudongchun Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}