A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
2020年10月19日 更新者：Symbiomix Therapeutics
A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis
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.
研究概览
详细说明
: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
研究类型
介入性
注册 (实际的)
215
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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California
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San Diego、California、美国、92123
- Women's Health Care Research Corp.
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Florida
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Clearwater、Florida、美国、33759
- Women's Medical Research Group, LLC
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North Miami、Florida、美国、33161
- Healthcare Clinical Data, Inc.
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Georgia
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Roswell、Georgia、美国、30075
- Atlanta North Gynecology, P.C
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Michigan
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Detroit、Michigan、美国、48201
- Wayne State University
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Saginaw、Michigan、美国、48604
- Saginaw Valley Medical Research Group, LLC
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New Jersey
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Lawrenceville、New Jersey、美国、08648
- Lawrence Ob-Gyn Clinical Research, LLC
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Plainsboro、New Jersey、美国、08536
- Scott Eder MD
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North Carolina
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New Bern、North Carolina、美国、28562
- Eastern Carolina Women's Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19114
- Clinical Research Of Philadelphia, Llc
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Tennessee
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Jackson、Tennessee、美国、38305
- The Jackson Clinic, PA
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Texas
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Houston、Texas、美国、77054
- TMC Life Research, Inc.
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San Antonio、Texas、美国、78229
- Clinical Trials of Texas, Inc.
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Virginia
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Virginia Beach、Virginia、美国、23502
- Tidewater Physicians for Women
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Washington
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Seattle、Washington、美国、98104
- University of Washington, Harborview Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
口服给药
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口服
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实验性的：SYM-1219 Low Dose
Administered orally
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Oral
其他名称：
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实验性的：SYM-1219 High Dose
Administered orally
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Oral
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cure of Bacterial Vaginosis
大体时间：Study Days 21-30
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Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount.
(Number of subjects with clinical cure at TOC/EOS)
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Study Days 21-30
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cure of Bacterial Vaginosis
大体时间：Study Days 21-30
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Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)
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Study Days 21-30
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Number of Patients With Therapeutic Cure
大体时间：Study Days 21-30
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Clinical Cure and Normalization of the Nugent score.
The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.
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Study Days 21-30
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Number of Patients With a Normal Nugent Score
大体时间：Study Days 21-30
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The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
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Study Days 21-30
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2014年10月1日
研究完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2014年5月16日
首先提交符合 QC 标准的
2014年5月27日
首次发布 (估计)
2014年5月28日
研究记录更新
最后更新发布 (实际的)
2020年11月13日
上次提交的符合 QC 标准的更新
2020年10月19日
最后验证
2020年10月1日
更多信息
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