Clinical trial NCT02452866: Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Lead sponsor: Symbiomix Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 325
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: La Mesa
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Groton
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Shawnee Mission
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Fall River
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Plainsboro
country: United States
state: New Jersey
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Myrtle Beach
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
References: