Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219

• Sponsor: Symbiomix Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02452866
• Collaborator: (none)
• Enrollment: 325
• Locations: 40
• Arm: 1
• Duration (Months): 4
• Patients Per Site: 8.1
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis	Drug: SYM-1219	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 325 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-center, Prospective, 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
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYM-1219 All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole	Drug: SYM-1219; Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water; Other Names: Secnidazole

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Are adult females or postmenarchal adolescent girls ≥ 12 years of age.

• Are in good general health as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.

• Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator

• Agree to abstain from alcohol for 3 days following study treatment.

• Have a clinical diagnosis of bacterial vaginosis

• Agree not to use vaginal douches or similar products for the duration of the study.

Exclusion Criteria:

• Are pregnant, lactating, or planning to become pregnant during the study.

• Are menstruating or have vaginal bleeding at the Baseline visit (Day 1).

• Are menopausal as determined by the Investigator

• Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex

• Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator

• Have consumed any alcohol within 12 hours prior to treatment with study medication.

• Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline visit (Day 1).

• Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35294
2		Phoenix	Arizona	United States	85018
3		Jonesboro	Arkansas	United States	72401
4		La Mesa	California	United States	91942
5		San Diego	California	United States	92108
6		Colorado Springs	Colorado	United States	80907
7		Denver	Colorado	United States	80209
8		Groton	Connecticut	United States	06340
9		Clearwater	Florida	United States	33759
10		Leesburg	Florida	United States	34748
11		Miami	Florida	United States	33186
12		North Miami	Florida	United States	33161
13		Plantation	Florida	United States	33324
14		Wellington	Florida	United States	33414
15		Atlanta	Georgia	United States	30312
16		Columbus	Georgia	United States	31904
17		Roswell	Georgia	United States	30075
18		Shawnee Mission	Kansas	United States	66218
19		Baltimore	Maryland	United States	21224
20		Fall River	Massachusetts	United States	02720
21		Grand Rapids	Michigan	United States	49503
22		Kalamazoo	Michigan	United States	49009
23		Saginaw	Michigan	United States	48604
24		Plainsboro	New Jersey	United States	08536
25		New Bern	North Carolina	United States	28562
26		Winston-Salem	North Carolina	United States	27103
27		Columbus	Ohio	United States	43213
28		Columbus	Ohio	United States	43231
29		Philadelphia	Pennsylvania	United States	19107
30		Philadelphia	Pennsylvania	United States	19114
31		Myrtle Beach	South Carolina	United States	29572
32		Jackson	Tennessee	United States	38305
33		Corpus Christi	Texas	United States	78414
34		Dallas	Texas	United States	75231
35		Houston	Texas	United States	77054
36		San Antonio	Texas	United States	78229
37		Norfolk	Virginia	United States	23507
38		Virginia Beach	Virginia	United States	23456
39		Seattle	Washington	United States	98104
40		Seattle	Washington	United States	98105

Sponsors and Collaborators

• Symbiomix Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Symbiomix Therapeutics
• ClinicalTrials.gov Identifier: NCT02452866
• Other Study ID Numbers: SYM-1219-350
• First Posted: May 25, 2015
• Last Update Posted: Apr 13, 2021
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Secnidazole

Study Results

Participant Flow

Arm/Group Title	SYM-1219
Arm/Group Description	Females 18 & over (not menopausal) with recurring incidences of bacterial vaginosis
Period Title: Overall Study
STARTED	325
COMPLETED	321
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	SYM-1219 2g
Arm/Group Description	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
Overall Participants	325
Age (Count of Participants)
<=18 years	2 0.6%
Between 18 and 65 years	323 99.4%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	325 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	72 22.2%
Not Hispanic or Latino	249 76.6%
Unknown or Not Reported	4 1.2%

Outcome Measures

1. Primary Outcome

Title	Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
Description	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)
Time Frame	30days

Outcome Measure Data

Analysis Population Description

Safety evaluations were based on the incidence, intensity, and type of AEs,vital signs, and clinical safety laboratory results.

Arm/Group Title	SYM-1219
Arm/Group Description	SYM-1219 Containing 2 Grams of Secnidazole
Measure Participants	325
Patients with 1 or more TEAE	95 29.2%
Pateints with Laboratory Abnormality	2 0.6%

Adverse Events

Arm/Group Title	SYM-1219 2g
Arm/Group Description	SYM-1219 2g single oral dose
All Cause Mortality
	SYM-1219 2g
	Affected / at Risk (%)	# Events
Total	0/321 (0%)
Serious Adverse Events
	SYM-1219 2g
	Affected / at Risk (%)	# Events
Total	1/321 (0.3%)
Injury, poisoning and procedural complications
foot burn	1/321 (0.3%)	1
Investigations
loss of consciousness	1/321 (0.3%)	1
Other (Not Including Serious) Adverse Events
	SYM-1219 2g
	Affected / at Risk (%)	# Events
Total	63/321 (19.6%)
Blood and lymphatic system disorders
Lymphadenopathy	0/321 (0%)	0
Gastrointestinal disorders
Nausea	1/321 (0.3%)	1
Infections and infestations
Nasopharyngitis	2/321 (0.6%)
Vulvovaginal candidiasis	9/321 (2.8%)
Chlamydia	1/321 (0.3%)	1
Fungal infection	0/321 (0%)	0
Gonorrhea	1/321 (0.3%)	1
Pyelonephritis	0/321 (0%)	0
Urinary tract infection	10/321 (3.1%)
Vaginal mycosis	2/321 (0.6%)	2
Tooth abscess	1/321 (0.3%)	1
Tooth infection	1/321 (0.3%)	1
Upper respiratory	2/321 (0.6%)	2
Acute sinusitis	0/321 (0%)	0
Vaginal candidiasis	0/321 (0%)	0
Vulvovaginal mycotic infection	18/321 (5.6%)
Bacterial vaginosis	3/321 (0.9%)
Genital herpes	2/321 (0.6%)
Cystitis	1/321 (0.3%)
Injury, poisoning and procedural complications
Thermal burn	1/321 (0.3%)	1
Nervous system disorders
headache	1/321 (0.3%)	1
dizziness	1/321 (0.3%)	1
dysgeusia	1/321 (0.3%)	1
Renal and urinary disorders
Chromaturia	1/321 (0.3%)	1
Reproductive system and breast disorders
Vaginal discharge	1/321 (0.3%)	1
Vaginal odor	1/321 (0.3%)	1
Vulvovaginal pruritis	1/321 (0.3%)	1
Vulvovaginal discomfort	0/321 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/321 (0.3%)	1
Surgical and medical procedures
Tooth extraction	0/321 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.