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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02452866
Study type	Interventional
Source	Symbiomix Therapeutics
Contact
Status	Completed
Phase	Phase 3
Start date	June 2015
Completion date	October 2015

View Details

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