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This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose.
Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYM-1219 | Experimental | All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYM-1219 | Drug | Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | Safety evaluations will be based on the incidence, intensity, and type of AEs of subjects with clinical cure at TOC/EOS (clinical cure basd on amsel + normalization of Nugent score) | 30days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | SYM-1219 | Females 18 & over (not menopausal) with recurring incidences of bacterial vaginosis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phoenix |
| Arizona |
| 85018 |
| United States |
| Jonesboro | Arkansas | 72401 | United States |
| La Mesa | California | 91942 | United States |
| San Diego | California | 92108 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Denver | Colorado | 80209 | United States |
| Groton | Connecticut | 06340 | United States |
| Clearwater | Florida | 33759 | United States |
| Leesburg | Florida | 34748 | United States |
| Miami | Florida | 33186 | United States |
| North Miami | Florida | 33161 | United States |
| Plantation | Florida | 33324 | United States |
| Wellington | Florida | 33414 | United States |
| Atlanta | Georgia | 30312 | United States |
| Columbus | Georgia | 31904 | United States |
| Roswell | Georgia | 30075 | United States |
| Shawnee Mission | Kansas | 66218 | United States |
| Baltimore | Maryland | 21224 | United States |
| Fall River | Massachusetts | 02720 | United States |
| Grand Rapids | Michigan | 49503 | United States |
| Kalamazoo | Michigan | 49009 | United States |
| Saginaw | Michigan | 48604 | United States |
| Plainsboro | New Jersey | 08536 | United States |
| New Bern | North Carolina | 28562 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Columbus | Ohio | 43213 | United States |
| Columbus | Ohio | 43231 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Jackson | Tennessee | 38305 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77054 | United States |
| San Antonio | Texas | 78229 | United States |
| Norfolk | Virginia | 23507 | United States |
| Virginia Beach | Virginia | 23456 | United States |
| Seattle | Washington | 98104 | United States |
| Seattle | Washington | 98105 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline Nugent score
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| ID | Title | Description |
|---|---|---|
| BG000 | SYM-1219 2g | Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of Women and Postmenarchal Adolescent Girls with Bacterial Vaginosis |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | 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 | Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | Safety evaluations will be based on the incidence, intensity, and type of AEs of subjects with clinical cure at TOC/EOS (clinical cure basd on amsel + normalization of Nugent score) | Safety evaluations were based on the incidence, intensity, and type of AEs,vital signs, and clinical safety laboratory results. | Posted | Count of Participants | Participants | 30days |
|
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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 | SYM-1219 2g | SYM-1219 2g single oral dose | 0 | 321 | 1 | 321 | 63 | 321 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| foot burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| loss of consciousness | Investigations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
| ||
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal odor | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulvovaginal pruritis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulvovaginal discomfort | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
| ||
| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Chlamydia | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Gonorrhea | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vaginal mycosis | Infections and infestations | Systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory | Infections and infestations | Systematic Assessment |
| ||
| Acute sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Vaginal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
| ||
| Bacterial vaginosis | Infections and infestations | Systematic Assessment |
| ||
| Genital herpes | Infections and infestations | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Operations | Symbiomix Therapeutics | 609-722-7250 | 112 | nadetoro@symbiomix.com |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C016724 | secnidazole |
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| Unknown or Not Reported |
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