Groton, Connecticut 06340

  • Bacterial Vaginosis

Purpose:

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 summary:

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.


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.


Study is Available At:


Original ID:

SYM-1219-350


NCT ID:

NCT02452866


Secondary ID:


Study Acronym:


Brief Title:

Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole


Official Title:

A Phase 3, 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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Symbiomix Therapeutics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

325


Enrollment Type:

Actual


Study Dates

Start Date:June 2015
Completion Date:October 2015
Completion Type:Actual
Primary Completion Date:October 2015
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 20, 2015
First Received Date:May 19, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety: Safety evaluations will be based on the incidence, intensity, and type of AEs, and changes in the patient's physical examination and pelvic examination findings
Time Frame:Assessed throughout the study (Days 1 - 30)
Safety Issues:True
Description:Vital signs, and clinical safety laboratory results. Safety variables will be tabulated and presented for all patients in the Safety population. Summarization will focus on incidence of any SAEs; treatment-emergent AEs by System Organ Class (SOC) and Pre
Outcome Type:Primary Outcome
Measure:Clinical Outcome: In your opinion, does the patient require additional treatment for bacterial vaginosis infection at this time? (Yes or No)
Time Frame:End of Study Visit (Day 21-30)
Safety Issues:False
Description:The Investigator will assess clinical outcome by answering the following question at the End of Study Visit: "In your opinion, does the patient require additional treatment for bacterial vaginosis infection at this time? The response will be recorded as Y

Study Interventions

Intervention Type:Drug
Name:SYM-1219
Description:Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Arm Name:SYM-1219

Study Arms

Study Arm Type:Experimental
Arm Name:SYM-1219

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Symbiomix Therapeutics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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