Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02713893
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004464', 'term': 'Econazole'}, {'id': 'D001591', 'term': 'Benzydamine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-15', 'studyFirstSubmitDate': '2015-08-07', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Adverse Events (AEs)', 'timeFrame': 'Up to 7 days after administration', 'description': "Occurrence of local Adverse Events (AEs) reported in the subject's diary as 1-3 scores for pruritus, burning sensation, pain, stinging, dryness; occurrence of all the other local AEs referred by the subject; occurrence of all the local Adverse Drug Reactions (ADRs) revealed by the Investigator"}], 'secondaryOutcomes': [{'measure': 'Econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base) plasma concentrations', 'timeFrame': 'At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1'}, {'measure': 'Area under the plasma concentration versus time curve [AUC(0-t)] of econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base)', 'timeFrame': 'At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1'}, {'measure': 'Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '15-16 days'}, {'measure': 'Change from screening in vital signs', 'timeFrame': 'From screening (from day -21 to day -7) at days 1 and 15 at pre-dose (0), 12 and 24 hours post-dose'}, {'measure': 'Change from screening in 12-leads ECG', 'timeFrame': 'From screening (from day -21 to day -7) at final visit (from day 17 to day 20)'}, {'measure': 'Change from screening in laboratory parameters', 'timeFrame': 'From screening (from day -21 to day -7) and at final visit (from day 17 to day 20)'}, {'measure': 'Change from screening in vaginal pH measurement', 'timeFrame': 'From screening (from day -21 to day -7), before the application on days 1, 2, 15, on days 6±1, 9±1, 12±1 at final visit (from day 17 to day 20)'}, {'measure': 'Change from screening in gynaecological examination findings', 'timeFrame': 'From screening (from day -21 to day -7) at final visit (from day 17 to day 20)'}, {'measure': 'Overall tolerability assessment scale', 'timeFrame': 'At final visit (from day 17 to day 20)'}, {'measure': 'Questionnaire for the comfort of use', 'timeFrame': 'At final visit (from day 17 to day 20)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Econazole nitrate 1%', 'Benzydamine HCl 0.12%', 'Intravaginal cream', 'Antimycotic', 'Tolerability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and repeated applications once a day for 15 days, safety of the investigational products and comfort of use will also be evaluated as secondary objectives.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent: signed written informed consent before inclusion in the study;\n2. Sex and age: females, aged 18-55 years old inclusive;\n3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive;\n4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest (sitting position);\n5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study;\n6. Sexual abstinence: agreement to sexual abstinence during the study;\n7. Contraception and fertility: women of child-bearing potential, even if sexual abstinent during the study as required by the study inclusion criteria, must be using at least one reliable method of contraception, as follows:\n\n 1. hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit;\n 2. a non-hormonal intrauterine device \\[IUD\\] for at least 2 months before the screening visit;\n 3. a male sexual partner who agrees to use a male condom;\n 4. a vasectomised sexual partner. Female participants of non-child-bearing potential will be admitted. For all female subjects, pregnancy test result must be negative at screening and at each scheduled evaluation;\n8. PAP test: negative result at PAP test (i.e. normal PAP test result without atypical cells) at screening.\n\nExclusion Criteria:\n\n1. ECG (12-leads, supine position): clinically significant abnormalities;\n2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study as judged by the investigator;\n3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness;\n4. Allergy: ascertained or presumptive hypersensitivity (including allergies) to the active ingredients (econazole and/ or benzydamine) and/or formulations' excipients or related drugs, e.g. other azoles; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study;\n5. Diseases: relevant history of renal, hepatic, gastrointestinal, genitourinary, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study or affect the subject's safety;\n6. Genitourinary disease: presence of any specific genitourinary symptoms detected at Visit 2 with the relevant questionnaire (genitourinary symptoms questionnaire);\n7. Infection history: history of bacterial urinary tract or bacterial and fungal vaginal infections for 3 weeks before the screening visit;\n8. Infections: bacterial or fungal infections (microbiology assessment);\n9. Gynaecological findings: clinically significant abnormal findings at the gynaecological visit performed by the study gynaecologist;\n10. Mucosa conditions: altered mucosa conditions affecting the site of application (e.g. open lesion or other);\n11. Vaginal conditions: use of vaginal detergents, soaps and washes that, in the investigator's opinion, may have an influence on vaginal pH and/or change the vaginal flora;\n12. Medications: any medication (topical or systemic), including over the counter, herbal medication, topical drugs on the application area and anticoagulants, such as warfarin and acenocoumarol, for 2 weeks before the start of the study. Hormonal contraceptives and hormonal replacement therapies are allowed. Paracetamol will be allowed as a counter-measure for adverse events, on a case by case basis, if deemed appropriate by the investigator;\n13. Investigative drug studies: participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of a previous study and the first day of the present study (date of the informed consent signature);\n14. Blood donation: blood donations for 3 months before this study;\n15. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (\\> 1 drink/day, defined according to USDA Dietary Guidelines 2010), tobacco (≥ 10 cigarettes/day) or caffeine (\\> 5 cups coffee/tea/day) abuse;\n16. Diet: Abnormal diets (\\< 1600 or \\> 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians\n17. Pregnancy: positive or missing pregnancy test at screening or day 1, pregnant or lactating women or females of child-bearing potential not following adequate contraceptive procedures;\n18. Non-compliance: subjects suspected to have a high potential for non-compliance to the study procedures according to the investigator's judgement, including non-compliance to sexual abstinence during the study;\n19. Drug test (cocaine, amphetamine, methamphetamine, cannabinoids, opiates and ecstasy): positive result at the drug test at screening\n20. Alcohol test: positive alcohol breath test at day 1"}, 'identificationModule': {'nctId': 'NCT02713893', 'briefTitle': 'Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aziende Chimiche Riunite Angelini Francesco S.p.A'}, 'officialTitle': 'A Phase I Study of a Novel Intravaginal Antimycotic Cream (Econazole Nitrate 1% Plus Benzydamine HCl 0.12%) Administered Once Daily for 15 Days to Healthy Women', 'orgStudyIdInfo': {'id': '030(4A)HO14387'}, 'secondaryIdInfos': [{'id': 'CRO-PK-14-289', 'type': 'OTHER', 'domain': 'CROSS Research S.A., Phase I Unit'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Econazole nitrate 1% plus Benzydamine HCl 0.12%', 'description': '5 grams of Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days', 'interventionNames': ['Drug: Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo plus Econazole nitrate 1%', 'description': '5 grams of Placebo plus Econazole nitrate 1% intravaginal cream, once daily for 15 consecutive days', 'interventionNames': ['Drug: Placebo plus Econazole nitrate 1% intravaginal cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo plus Benzydamine HCl 0.12%', 'description': '5 grams of Placebo plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days.', 'interventionNames': ['Drug: Placebo plus Benzydamine HCl 0.12% intravaginal cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '5 grams of Placebo intravaginal cream, once daily for 15 consecutive days.', 'interventionNames': ['Drug: Placebo intravaginal cream']}], 'interventions': [{'name': 'Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream', 'type': 'DRUG', 'armGroupLabels': ['Econazole nitrate 1% plus Benzydamine HCl 0.12%']}, {'name': 'Placebo plus Econazole nitrate 1% intravaginal cream', 'type': 'DRUG', 'armGroupLabels': ['Placebo plus Econazole nitrate 1%']}, {'name': 'Placebo plus Benzydamine HCl 0.12% intravaginal cream', 'type': 'DRUG', 'armGroupLabels': ['Placebo plus Benzydamine HCl 0.12%']}, {'name': 'Placebo intravaginal cream', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-6864', 'city': 'Arzo', 'country': 'Switzerland', 'facility': 'CROSS Research S.A., Phase I Unit', 'geoPoint': {'lat': 45.87606, 'lon': 8.94103}}], 'overallOfficials': [{'name': 'Milko Radicioni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cross Research S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aziende Chimiche Riunite Angelini Francesco S.p.A', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cross Research S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}