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| Name | Class |
|---|---|
| Premier Research | OTHER |
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This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Drug | Experimental | GDC-229 gel applied vaginally as directed. |
|
| Reference Drug | Active Comparator | Metronidazole Vaginal Gel, 0.75% applied vaginally as directed. |
|
| Vehicle Placebo Gel | Placebo Comparator | GDC-229 Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-229 | Drug | GDC-229 is a vaginal gel. |
| |
| Metronidazole Vaginal Gel 0.75% |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure | Resolution of clinical signs and symptoms | Day 21-30 |
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Inclusion Criteria:
Exclusion Criteria:
Non-pregnant female aged ≥ 18 years who is in good general health
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 103 | Raleigh | North Carolina | 27612 | United States |
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All subjects who met the entry criteria were randomized and enrolled into the study.
Recruitment Period: March 2017 to November 2017
The location of clinical sites included women's health clinics and clinical research centers
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Drug | GDC-229 gel applied vaginally as directed. GDC-229: GDC-229 is a vaginal gel. |
| FG001 | Reference Drug | Metronidazole Vaginal Gel, 0.75% applied vaginally as directed. Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug |
| FG002 | Vehicle Placebo Gel | GDC-229 Vehicle Placebo: Inactive arm of the study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Drug | GDC-229 gel applied vaginally as directed. GDC-229: GDC-229 is a vaginal gel. |
| BG001 | Reference Drug | Metronidazole Vaginal Gel, 0.75% applied vaginally as directed. Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Clinical Cure | Resolution of clinical signs and symptoms | Modified Intent-to-Treat (mITT) population: All randomized subjects who received study treatment and returned for at least one post-baseline visit, but excluding those who demonstrate a positive test result for other concomitant vaginal or cervical infections at baseline (e.g. C. trachomatis, N. gonorrhoeae) or who have a baseline Nugent score<4. | Posted | Count of Participants | Participants | Day 21-30 |
|
21 months
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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 | Test Drug | GDC-229 gel applied vaginally as directed. GDC-229: GDC-229 is a vaginal gel. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intussusception | Gastrointestinal disorders | Systematic Assessment | Enterocolic Intussusception |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gage Development Company | Gage Development Company | 1-847-999-0600 | clinicalinfo@capstonedevservices.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2017 | Sep 24, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2018 | Sep 24, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014623 | Vaginal Diseases |
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Double-blind
| Drug |
Metronidazole Vaginal Gel 0.75% is an FDA-approved drug |
|
| Placebo | Drug | Inactive arm of the study |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Noncompliance with study drug |
|
| Physician Decision |
|
| Abnormal Laboratory Value |
|
| BG002 | Vehicle Placebo Gel | GDC-229 Vehicle Placebo: Inactive arm of the study |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Vehicle Placebo Gel | GDC-229 Vehicle Placebo: Inactive arm of the study |
|
|
|
| 0 |
| 287 |
| 2 |
| 287 |
| 44 |
| 287 |
| EG001 | Reference Drug | Metronidazole Vaginal Gel, 0.75% applied vaginally as directed. Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug | 0 | 285 | 0 | 285 | 37 | 285 |
| EG002 | Vehicle Placebo Gel | GDC-229 Vehicle Placebo: Inactive arm of the study | 0 | 292 | 2 | 292 | 35 | 292 |
|
| Cholecystitis Acute | Hepatobiliary disorders | Systematic Assessment | Acute Cholecystitis |
|
| Sickle Cell Anaemia | Congenital, familial and genetic disorders | Systematic Assessment | Worsening Sickle Cell Anemia |
|
| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment | Exacerbation Of Supraventricular Tachycardia |
|
| Trichomoniasis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |