A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

• Sponsor: Symbiomix Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02147899
• Collaborator: (none)
• Enrollment: 215
• Locations: 16
• Arms: 3
• Duration (Months): 5
• Patients Per Site: 13.4
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis	Drug: SYM-1219; Drug: Placebo	Phase 2

Detailed Description

:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Study Design

• Study Type: Interventional
• Actual Enrollment: 215 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYM-1219 Low Dose Administered orally	Drug: SYM-1219; Oral; Other Names: Secnidazole
Experimental: SYM-1219 High Dose Administered orally	Drug: SYM-1219; Oral; Other Names: Secnidazole
Placebo Comparator: Placebo Administered orally	Drug: Placebo; Oral

Outcome Measures

Primary Outcome Measures

1. Cure of Bacterial Vaginosis [Study Days 21-30]

   Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)

Secondary Outcome Measures

1. Cure of Bacterial Vaginosis [Study Days 21-30]

   Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)

2. Number of Patients With Therapeutic Cure [Study Days 21-30]

   Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.

3. Number of Patients With a Normal Nugent Score [Study Days 21-30]

   The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Are females at least 18 years of age in good general health who are not menopausal.

• Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:

• Off-white (milky or gray), thin, homogeneous vaginal discharge

• Vaginal pH ≥ 4.7

• Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount

• A positive 10% KOH Whiff test.

• Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

Exclusion Criteria:

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

• 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 received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline visit (Day 1).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Women's Health Care Research Corp.	San Diego	California	United States	92123
3	Women's Medical Research Group, LLC	Clearwater	Florida	United States	33759
4	Healthcare Clinical Data, Inc.	North Miami	Florida	United States	33161
5	Atlanta North Gynecology, P.C	Roswell	Georgia	United States	30075
6	Wayne State University	Detroit	Michigan	United States	48201
7	Saginaw Valley Medical Research Group, LLC	Saginaw	Michigan	United States	48604
8	Lawrence OB-GYN Clinical Research, LLC	Lawrenceville	New Jersey	United States	08648
9	Scott Eder MD	Plainsboro	New Jersey	United States	08536
10	Eastern Carolina Women's Center	New Bern	North Carolina	United States	28562
11	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania	United States	19114
12	The Jackson Clinic, PA	Jackson	Tennessee	United States	38305
13	TMC Life Research, Inc.	Houston	Texas	United States	77054
14	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
15	Tidewater Physicians for Women	Virginia Beach	Virginia	United States	23502
16	University of Washington, Harborview Medical Center	Seattle	Washington	United States	98104

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: NCT02147899
• Other Study ID Numbers: SYM-1219-201
• First Posted: May 28, 2014
• Last Update Posted: Nov 13, 2020
• Last Verified: Oct 1, 2020

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

Study Results

Participant Flow

Arm/Group Title	SYM-1219 Low Dose	SYM-1219 High Dose	Placebo
Arm/Group Description	Administered orally SYM-1219	Administered orally SYM-1219	Administered orally Placebo
Period Title: Overall Study
STARTED	71	72	72
COMPLETED	71	72	72
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	SYM-1219 Low Dose	SYM-1219 High Dose	Placebo	Total
Arm/Group Description	Administered orally SYM-1219	Administered orally SYM-1219	Administered orally Placebo	Total of all reporting groups
Overall Participants	71	72	72	215
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	71 100%	72 100%	72 100%	215 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	71 100%	72 100%	72 100%	215 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 9.9%	8 11.1%	8 11.1%	23 10.7%
Not Hispanic or Latino	64 90.1%	64 88.9%	64 88.9%	192 89.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	71 100%	72 100%	72 100%	215 100%

Outcome Measures

1. Primary Outcome

Title	Cure of Bacterial Vaginosis
Description	Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)
Time Frame	Study Days 21-30

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	SYM-1219 Low Dose	SYM-1219 High Dose	Placebo
Arm/Group Description	Administered orally SYM-1219	Administered orally SYM-1219	Administered orally Placebo
Measure Participants	64	62	62
Clinical Outcome Responder	33 46.5%	42 58.3%	11 15.3%
Non-Responder	31 43.7%	20 27.8%	51 70.8%

2. Secondary Outcome

Title	Cure of Bacterial Vaginosis
Description	Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)
Time Frame	Study Days 21-30

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	SYM-1219 Low Dose	SYM-1219 High Dose	Placebo
Arm/Group Description	Administered orally SYM-1219	Administered orally SYM-1219	Administered orally Placebo
Measure Participants	64	62	62
Count of Participants [Participants]	64 90.1%	62 86.1%	62 86.1%

3. Secondary Outcome

Title	Number of Patients With Therapeutic Cure
Description	Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.
Time Frame	Study Days 21-30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SYM-1219 Low Dose	SYM-1219 High Dose	Placebo
Arm/Group Description	Administered orally SYM-1219	Administered orally SYM-1219	Administered orally Placebo
Measure Participants	64	62	62
Count of Participants [Participants]	14 19.7%	25 34.7%	4 5.6%

4. Secondary Outcome

Title	Number of Patients With a Normal Nugent Score
Description	The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Time Frame	Study Days 21-30

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	SYM-1219 Low Dose	SYM-1219 High Dose	Placebo
Arm/Group Description	Administered orally SYM-1219	Administered orally SYM-1219	Administered orally Placebo
Measure Participants	64	62	62
Nugent Score 0-3 (Normal)	15 21.1%	25 34.7%	4 5.6%
Nugent Score ≥4 (Abnormal)	49 69%	37 51.4%	58 80.6%

Adverse Events

Arm/Group Title	SYM-1219 Low Dose		SYM-1219 High Dose		Placebo
Arm/Group Description	Administered orally SYM-1219		Administered orally SYM-1219		Administered orally Placebo
All Cause Mortality
	SYM-1219 Low Dose		SYM-1219 High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/72 (0%)		0/72 (0%)
Serious Adverse Events
	SYM-1219 Low Dose		SYM-1219 High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/72 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	SYM-1219 Low Dose		SYM-1219 High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/71 (12.7%)		14/72 (19.4%)		7/72 (9.7%)
Blood and lymphatic system disorders
Lymphadenopathy	1/71 (1.4%)		0/72 (0%)		0/72 (0%)
Gastrointestinal disorders
Nausea	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Infections and infestations
Candida	1/71 (1.4%)		0/72 (0%)		0/72 (0%)
Chlamydia	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Fungal infection	1/71 (1.4%)		0/72 (0%)		1/72 (1.4%)
Gonorrhea	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Pyelonephritis	1/71 (1.4%)		0/72 (0%)		0/72 (0%)
Urinary tract infection	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Vaginal mycosis	0/71 (0%)		2/72 (2.8%)		1/72 (1.4%)
Tooth abscess	0/71 (0%)		1/72 (1.4%)		1/72 (1.4%)
Tooth infection	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Upper respiratory	0/71 (0%)		2/72 (2.8%)		2/72 (2.8%)
Acute sinusitis	0/71 (0%)		0/72 (0%)		1/72 (1.4%)
Vaginal candidiasis	1/71 (1.4%)		0/72 (0%)		1/72 (1.4%)
Injury, poisoning and procedural complications
Thermal burn	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Investigations
ALT increased	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
AST increased	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoid tumor	1/71 (1.4%)		0/72 (0%)		0/72 (0%)
Nervous system disorders
headache	1/71 (1.4%)		1/72 (1.4%)		0/72 (0%)
dizziness	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
dysgeusia	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Renal and urinary disorders
Chromaturia	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Nephrolithiasis	1/71 (1.4%)		0/72 (0%)		0/72 (0%)
Reproductive system and breast disorders
Vaginal discharge	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Vaginal odor	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Vulvovaginal pruritis	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Vulvovaginal discomfort	1/71 (1.4%)		0/72 (0%)		0/72 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/71 (0%)		1/72 (1.4%)		0/72 (0%)
Surgical and medical procedures
Tooth extraction	0/71 (0%)		0/72 (0%)		1/72 (1.4%)

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.