Trial · NCT02452866
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
NCT02452866, Phase 3, Completed, Symbiomix Therapeutics; results first posted 2021-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219. Trials, record NCT02452866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02452866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
- NCT number
- NCT02452866
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 325 participants, actual
- Lead sponsor
- Symbiomix Therapeutics
- Conditions
- Bacterial Vaginosis
- Interventions
- SYM-1219
- First posted
- 2015-05-25
- Last updated
- 2021-04-13
- Results first posted
- 2021-04-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | 30days | 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) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | 30days | Safety evaluations were based on the incidence, intensity, and type of AEs,vital signs, and clinical safety laboratory results. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | SYM-1219 | Patients with 1 or more TEAE | 95 | Participants | |
| Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | SYM-1219 | Pateints with Laboratory Abnormality | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SYM-1219 | 325 | |
| Overall Study | COMPLETED | SYM-1219 | 321 | |
| Overall Study | NOT COMPLETED | SYM-1219 | 4 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | headache | Nervous system disorders | SYM-1219 2g | 1 | 321 | 1 |
| other | dizziness | Nervous system disorders | SYM-1219 2g | 1 | 321 | 1 |
| other | dysgeusia | Nervous system disorders | SYM-1219 2g | 1 | 321 | 1 |
| other | Vaginal discharge | Reproductive system and breast disorders | SYM-1219 2g | 1 | 321 | 1 |
| other | Vaginal odor | Reproductive system and breast disorders | SYM-1219 2g | 1 | 321 | 1 |
| other | Vulvovaginal pruritis | Reproductive system and breast disorders | SYM-1219 2g | 1 | 321 | 1 |
| other | Vulvovaginal discomfort | Reproductive system and breast disorders | SYM-1219 2g | 0 | 321 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | SYM-1219 2g | 0 | 321 | 0 |
| other | Chromaturia | Renal and urinary disorders | SYM-1219 2g | 1 | 321 | 1 |
| other | Nasopharyngitis | Infections and infestations | SYM-1219 2g | 2 | 321 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SYM-1219 2g | 0 | 321 |
| Total, other adverse events | SYM-1219 2g | 63 | 321 |
| Total, serious adverse events | SYM-1219 2g | 1 | 321 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02452866
GET https://conductscience.org/api/trials/v1/NCT02452866/events?page=2