Trial Outcomes & Findings for Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219 (NCT NCT02452866)
NCT ID: NCT02452866
Last Updated: 2021-04-13
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
30days
Results posted on
2021-04-13
Participant Flow
Participant milestones
| Measure |
SYM-1219
Females 18 \& over (not menopausal) with recurring incidences of bacterial vaginosis
|
|---|---|
|
Overall Study
STARTED
|
325
|
|
Overall Study
COMPLETED
|
321
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
Baseline characteristics by cohort
| Measure |
SYM-1219 2g
n=325 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
323 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
325 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
249 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30daysPopulation: Safety evaluations were based on the incidence, intensity, and type of AEs,vital signs, and clinical safety laboratory results.
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)
Outcome measures
| Measure |
SYM-1219
n=325 Participants
SYM-1219 Containing 2 Grams of Secnidazole
|
|---|---|
|
Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
Patients with 1 or more TEAE
|
95 Participants
|
|
Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
Pateints with Laboratory Abnormality
|
2 Participants
|
Adverse Events
SYM-1219 2g
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SYM-1219 2g
n=321 participants at risk
SYM-1219 2g single oral dose
|
|---|---|
|
Injury, poisoning and procedural complications
foot burn
|
0.31%
1/321 • Number of events 1
|
|
Investigations
loss of consciousness
|
0.31%
1/321 • Number of events 1
|
Other adverse events
| Measure |
SYM-1219 2g
n=321 participants at risk
SYM-1219 2g single oral dose
|
|---|---|
|
Nervous system disorders
headache
|
0.31%
1/321 • Number of events 1
|
|
Nervous system disorders
dizziness
|
0.31%
1/321 • Number of events 1
|
|
Nervous system disorders
dysgeusia
|
0.31%
1/321 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.31%
1/321 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal odor
|
0.31%
1/321 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
0.31%
1/321 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/321
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/321
|
|
Renal and urinary disorders
Chromaturia
|
0.31%
1/321 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.62%
2/321
|
|
Gastrointestinal disorders
Nausea
|
0.31%
1/321 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.31%
1/321 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.31%
1/321 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/321
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.8%
9/321
|
|
Infections and infestations
Chlamydia
|
0.31%
1/321 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
0.00%
0/321
|
|
Infections and infestations
Gonorrhea
|
0.31%
1/321 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/321
|
|
Infections and infestations
Urinary tract infection
|
3.1%
10/321
|
|
Infections and infestations
Vaginal mycosis
|
0.62%
2/321 • Number of events 2
|
|
Infections and infestations
Tooth abscess
|
0.31%
1/321 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.31%
1/321 • Number of events 1
|
|
Infections and infestations
Upper respiratory
|
0.62%
2/321 • Number of events 2
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/321
|
|
Infections and infestations
Vaginal candidiasis
|
0.00%
0/321
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.6%
18/321
|
|
Infections and infestations
Bacterial vaginosis
|
0.93%
3/321
|
|
Infections and infestations
Genital herpes
|
0.62%
2/321
|
|
Infections and infestations
Cystitis
|
0.31%
1/321
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place