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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016655-21 | EudraCT Number |
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In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo pessary, single dose |
|
| Arasertaconazole nitrate 150 mg | Experimental | Arasertaconazole nitrate 150 mg pessary, single dose |
|
| arasertaconazole nitrate 300 mg | Experimental | Arasertaconazole nitrate 300 mg pessary, single dose |
|
| arasertaconazole 600 mg | Experimental | Arasertaconazole nitrate 600 mg pessary, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arasertaconazole nitrate | Drug | Arasertaconazole nitrate pessary, placebo pessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response of Clinical and Mycological (Global) Therapeutic Response | Global therapeutic response at day 26± 4 days ("TOC"- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline "Vulvovaginal Candidiasis -Developing Antimicrobial Drugs for Treatment". | day 26 ± 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response of Clinical and Mycological (Global)Therapeutic Response | Global therapeutic response at day 8± 2 days. Safety and tolerability. | Day 8 ± 2 days |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferrer Internacional S.A. | Barcelona | 08028 | Spain |
After signed informed consent, VVC clinical signs and symptoms were assessed,(KOH) wet mounts and samples for mycological culture obtained.Baseline safety assessments, including pregnancy were performed. If all inclusion criteria and none of the exclusion criteria were met, the subject was randomized in the same day to one of the treatment groups.
The subjects were randomized to a treatment arm using an interactive web response system (IWRS). Placebo and study drug pessaries were dispensed as a kit, and all subjects were instructed in proper self-administration of the pessaries (at bedtime while lying down). Study initiation date was 15June2010 and completed on 15 Nov 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo pessary, single dose |
| FG001 | Arasertaconazole Nitrate 150 mg | Arasertaconazole nitrate 150 mg pessary, single dose |
| FG002 | Arasertaconazole Nitrate 300 mg | Arasertaconazole nitrate 300 mg pessary, single dose |
| FG003 | Arasertaconazole 600 mg | Arasertaconazole nitrate 600 mg pessary, single dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo pessary, single dose |
| BG001 | Arasertaconazole Nitrate 150 mg | Arasertaconazole nitrate 150 mg pessary, single dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose-response of Clinical and Mycological (Global) Therapeutic Response | Global therapeutic response at day 26± 4 days ("TOC"- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline "Vulvovaginal Candidiasis -Developing Antimicrobial Drugs for Treatment". | The full analysis set (FAS) was the primary population for the analysis of all efficacy endpoints. The FAS was defined as all randomized subjects who received at least 1 dose of a study drug.Subjects in the FAS were analyzed according to randomized treatment group. | Posted | Number | 95% Confidence Interval | percentage of patients cured | day 26 ± 4 days |
|
Study Initiation Date: 15 June 2010 Study Completion Date: 15 November 2010
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo pessary, single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tonsilitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment | moderate, not related,recovered |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Dvorak | Privatni gynekologicka ambulance | +420 542 221 661 | ssgcr@ti.cz |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
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| placebo | Drug | placebo, single dose |
|
| BG002 | Arasertaconazole Nitrate 300 mg | Arasertaconazole nitrate 300 mg pessary, single dose |
| BG003 | Arasertaconazole 600 mg | Arasertaconazole nitrate 600 mg pessary, single dose |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Arasertaconazole Nitrate 150 mg |
Arasertaconazole nitrate 150 mg pessary, single dose |
| OG002 | Arasertaconazole Nitrate 300 mg | Arasertaconazole nitrate 300 mg pessary, single dose |
| OG003 | Arasertaconazole 600 mg | Arasertaconazole nitrate 600 mg pessary, single dose |
|
|
|
| Secondary | Dose-response of Clinical and Mycological (Global)Therapeutic Response | Global therapeutic response at day 8± 2 days. Safety and tolerability. | Dose response tested using logistic regression-linear coefficient for treatment effect.Assuming response rate 80% for 600 mg, 75% for 300 mg, 65% for 150 mg and 50% for the placebo group, sample size of 45 subjects in each group have 90% power to detect linear dose response with 0.05 two-sided test of trend based on the logistic model. | Posted | Number | 95% Confidence Interval | percentage of cured participants | Day 8 ± 2 days |
|
|
|
| 0 |
| 57 |
| 6 |
| 57 |
| EG001 | Arasertaconazole Nitrate 150 mg | Arasertaconazole nitrate 150 mg pessary, single dose | 0 | 58 | 9 | 58 |
| EG002 | Arasertaconazole Nitrate 300 mg | Arasertaconazole nitrate 300 mg pessary, single dose | 0 | 58 | 13 | 58 |
| EG003 | Arasertaconazole 600 mg | Arasertaconazole nitrate 600 mg pessary, single dose | 0 | 56 | 13 | 56 |
|
| Chamydial infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment | mild, not related, recovering |
|
| heat stroke | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment | mild, possible related, recovered |
|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| abdominal distension | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment | mild, possible related, recovered |
|
| vaginal infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| rhinitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment | moderate, unlikely, recovered |
|
| arrhythmia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment | mild, unlikely, recovered |
|
| vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment | mild, unlikely, recovered |
|
| bloody discharge | General disorders | MedDRA (13.0) | Systematic Assessment | mild, possible related, recovered |
|
| influenza | Infections and infestations | MedDRA (13.0) | Systematic Assessment | mild-moderate, not related, recovered |
|
| electrocardiogram TWave decreased | Investigations | MedDRA (13.0) | Systematic Assessment | moderate, not assessable, recovered |
|
| pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (13.0) | Systematic Assessment | There were 2 pregnancy cases. Patient exposed to 600 mg Arasertaconazole delivered healthy boy at 38th week gestation. Investigator last report received patient exposed to 300 mg Arasertaconazole: Ultrasound at 20th week of gestation was normal. |
|
| vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment | severe, probable related, recovered |
|
| dyspareunia | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment | moderate, not related, recovered |
|
| nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| vaginitis bacterial | Infections and infestations | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| blood bilirrubin increased | Investigations | MedDRA (13.0) | Systematic Assessment | mild, not related, not recovered |
|
| migraine | Nervous system disorders | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| urinary incontinence | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment | moderate, possible related, recovered |
|
| pelvic pain | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment | moderate, not related, recovered |
|
| uterine haemorrhage | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment | mild, possible related, recovered |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
| rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment | mild, not related, recovered |
|
The only disclosure restriction on the PI is that the sponsor can review publications and/or presentations (results communications) prior to public release and communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor may require changes to the publication and /or presentation regarding its content or the time of release.
| D014627 |
| Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |