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

NCT ID: NCT02147899

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-10-31

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.

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

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SYM-1219 Low Dose

Administered orally

Group Type: EXPERIMENTAL

SYM-1219

Intervention Type: DRUG

Oral

SYM-1219 High Dose

Administered orally

Group Type: EXPERIMENTAL

SYM-1219

Intervention Type: DRUG

Oral

Placebo

Administered orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral

Interventions

SYM-1219

Oral

Intervention Type: DRUG

Placebo

Oral

Intervention Type: DRUG

Other Intervention Names

Secnidazole

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Symbiomix Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Women's Health Care Research Corp.

San Diego, California, United States

Women's Medical Research Group, LLC

Clearwater, Florida, United States

Healthcare Clinical Data, Inc.

North Miami, Florida, United States

Atlanta North Gynecology, P.C

Roswell, Georgia, United States

Wayne State University

Detroit, Michigan, United States

Saginaw Valley Medical Research Group, LLC

Saginaw, Michigan, United States

Lawrence OB-GYN Clinical Research, LLC

Lawrenceville, New Jersey, United States

Scott Eder MD

Plainsboro, New Jersey, United States

Eastern Carolina Women's Center

New Bern, North Carolina, United States

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, United States

The Jackson Clinic, PA

Jackson, Tennessee, United States

TMC Life Research, Inc.

Houston, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Tidewater Physicians for Women

Virginia Beach, Virginia, United States

University of Washington, Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

Hillier SL, Nyirjesy P, Waldbaum AS, Schwebke JR, Morgan FG, Adetoro NA, Braun CJ. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):379-386. doi: 10.1097/AOG.0000000000002135.

Reference Type: DERIVED

PMID: 28697102 (View on PubMed)

Other Identifiers

SYM-1219-201

Identifier Type: -

Identifier Source: org_study_id