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The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYM-1219 | Experimental | Administered orally |
|
| Placebo | Placebo Comparator | Administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYM-1219 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome Responder Rate | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20% | Study Days 21-30 (End of Study (EOS)) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome Responder Rate (Interim Visit Only) | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20% | Study Days 7-14 (interim) |
| Gram Stain Slide Nugent Score |
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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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Female post-menarchal participants age 12 and older, inclusive, with a clinical diagnosis of bacterial vaginosis were recruited and enrolled in 21 investigative medical sites throughout the US. Recruitment/enrollment took place between May 4, 2015 and Sep 24, 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | SYM-1219 | 2 grams administered orally as a single dose SYM-1219 |
| FG001 | Placebo | Administered orally as a single dose Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal
| Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS) |
| Therapeutic Outcome Responder Rate | A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3) | Study days 7-14 (interim) & study days 21-30 (EOS) |
| Investigator's Clinical Assessment | Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No) | Study days 21-30 End of Study (EOS) |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| San Diego | California | 92108 | United States |
| Colorado Springs | Colorado | 80910 | United States |
| Denver | Colorado | 80209 | United States |
| Leesburg | Florida | 34748 | United States |
| Miami | Florida | 33161 | United States |
| Wellington | Florida | 33414 | United States |
| Atlanta | Georgia | 30312 | United States |
| Baltimore | Maryland | 21224 | United States |
| Grand Rapids | Michigan | 49503 | United States |
| Plainsboro | New Jersey | 08536 | United States |
| New Bern | North Carolina | 28562 | United States |
| Columbus | Ohio | 73212 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Houston | Texas | 77054 | United States |
| Virginia Beach | Virginia | 23456 | United States |
| Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Participants deemed eligible at baseline who received a dose from either arm
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| ID | Title | Description |
|---|---|---|
| BG000 | SYM-1219 | 2 grams administered orally as a single dose SYM-1219 |
| BG001 | Placebo | Administered orally as a single dose Placebo |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 Outcome Responder Rate | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20% | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Posted | Count of Participants | Participants | Study Days 21-30 (End of Study (EOS)) |
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| Secondary | Clinical Outcome Responder Rate (Interim Visit Only) | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20% | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria | Posted | Count of Participants | Participants | Study Days 7-14 (interim) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Gram Stain Slide Nugent Score | A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Posted | Count of Participants | Participants | Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Therapeutic Outcome Responder Rate | A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3) | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Posted | Count of Participants | Participants | Study days 7-14 (interim) & study days 21-30 (EOS) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Investigator's Clinical Assessment | Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No) | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Posted | Count of Participants | Participants | Study days 21-30 End of Study (EOS) |
|
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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 | 2 grams administered orally as a single dose SYM-1219 | 0 | 125 | 2 | 125 | 43 | 125 |
| EG001 | Placebo | Administered orally as a single dose Placebo | 0 | 64 | 0 | 64 | 14 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Subcutaneous abcess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Vulvovaginal pruritis | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Vulvovaginal erythema | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
PI submits complete copy of publication material to sponsor at least 60 days prior to submission implementing all reasonable sponsor comments. If sponsor determines that proposed publication contains disclosure of intellectual property for which sponsor is seeking patent protection, PI shall delay submission 60 days from sponsor notice so sponsor may file patent application covering intellectual property. PI shall have no further rights to publish sponsor confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Kaufman, MD | Lupin Pharmaceuticals Inc | 908.603.6062 | gregorykaufman@lupin.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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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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