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

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: SYM-1219

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 Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
  • Arizona
    • Phoenix, Arizona, United States, 85018
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
  • California
    • La Mesa, California, United States, 91942
    • San Diego, California, United States, 92108
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
    • Denver, Colorado, United States, 80209
  • Connecticut
    • Groton, Connecticut, United States, 06340
  • Florida
    • Clearwater, Florida, United States, 33759
    • Leesburg, Florida, United States, 34748
    • Miami, Florida, United States, 33186
    • North Miami, Florida, United States, 33161
    • Plantation, Florida, United States, 33324
    • Wellington, Florida, United States, 33414
  • Georgia
    • Atlanta, Georgia, United States, 30312
    • Columbus, Georgia, United States, 31904
    • Roswell, Georgia, United States, 30075
  • Kansas
    • Shawnee Mission, Kansas, United States, 66218
  • Maryland
    • Baltimore, Maryland, United States, 21224
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
    • Kalamazoo, Michigan, United States, 49009
    • Saginaw, Michigan, United States, 48604
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
  • North Carolina
    • New Bern, North Carolina, United States, 28562
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Columbus, Ohio, United States, 43213
    • Columbus, Ohio, United States, 43231
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
    • Philadelphia, Pennsylvania, United States, 19114
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
  • Tennessee
    • Jackson, Tennessee, United States, 38305
  • Texas
    • Corpus Christi, Texas, United States, 78414
    • Dallas, Texas, United States, 75231
    • Houston, Texas, United States, 77054
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Norfolk, Virginia, United States, 23507
    • Virginia Beach, Virginia, United States, 23456
  • Washington
    • Seattle, Washington, United States, 98104
    • Seattle, Washington, United States, 98105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Symbiomix Therapeutics

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Secnidazole
• Other Study ID Numbers: SYM-1219-350