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Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections

2012年10月1日 更新者：Dr Bharti Daswani

A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two Different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Vaginal Infections

Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.

研究概览

地位

完全的

条件

干预/治疗

详细说明

  • This is a Randomized, Comparative, Prospective, Open label, Single center study to compare the 3 day treatment course of intravaginal soft gelatin capsule containing clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial, trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and to study the in vitro drug release pattern of intravaginal soft gelatin capsule and intravaginal ER tablets containing clindamycin and clotrimazole.
  • The study will be conducted in B.J. Medical College & Sassoon General Hospitals, Pune. The study will be completed in 60 patients [30 patients in each group].
  • The primary outcome measure is absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission].

  • The secondary outcome measures will be

    1. absence of any clinical sign suggestive of infective vaginitis and
    2. a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 29th day after start of treatment [Effectiveness in maintaining a remission] and ability to complete the 3day course without any break or experiencing intolerable side effects [Tolerability].

研究类型

介入性

注册 (实际的)

73

阶段

  • 第四阶段

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

  • 印度
    • Maharashtra
      • Pune、Maharashtra、印度、411001
        • BJ Govt. Medical College & Sassoon General Hospitals, Pune

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 至 65年 (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:

  • Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin [based on symptoms and signs on per speculum examination]
  • Age at least 18 years
  • Capable of giving written informed consent
  • Agree to no intercourse for 8 days from the day of start of treatment
  • Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)

Exclusion Criteria:

  • Post-menopausal women
  • Menstruating at diagnosis
  • Pregnancy
  • Any antifungal or antibiotic use 14 days prior to enrolment
  • Use of oral or intravaginal antibiotics within the past 2 weeks
  • Immunosuppressive drug within 4 months
  • Presence of vaginal / vulval ulcer
  • Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response
  • Inability to keep return appointments
  • History of hypersensitivity to clotrimazole, clindamycin or lincomycin
  • History of regional enteritis, ulcerative colitis or antibiotic associated colitis
  • Significant disease or acute illness that in the Investigators assessment could complicate the evaluation
  • Intrauterine Device

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：ClinSupV3 -soft gelatin capsule
Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days
药品：ClinSupV3 -soft gelatin capsule
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
其他名称：
  • Clindamycin plus Clotrimazole
有源比较器：ClinSupV3ER- Extended release tablet
ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.
药品：ClinSupV3ER- Extended release tablet
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
其他名称：
  • Clindamycin plus Clotrimazole

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
Primary outcome measure for Global effectiveness
大体时间：On 8th day after start of treatment
Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis
On 8th day after start of treatment

次要结果测量

结果测量
措施说明
大体时间
Secondary outcome measures for Global effectiveness
大体时间：29th day after initiation of treatment
Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial,trichomonal or candidal vaginitis
29th day after initiation of treatment
Secondary outcome measures for tolerability
大体时间：8th day after start of treatment
Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects
8th day after start of treatment

其他结果措施

结果测量
措施说明
大体时间
Clinical Response
大体时间：at 8th day and 29th day after initiation of treatment
Number of the patients showing normalization of vaginal pH to 4.5
at 8th day and 29th day after initiation of treatment
Clinical response
大体时间：at 8th and 29th day after start of treatment
Number of the patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline
at 8th and 29th day after start of treatment
Clinical response
大体时间：at 8th day and 29th day after start of treatment
Number of the patients achieving improvement in scores for itching by at least 1 unit from baseline
at 8th day and 29th day after start of treatment

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。

赞助

Dr Bharti Daswani

合作者

Resilient Cosmeceuticals Pvt. Ltd, Pune

调查人员

  • 首席研究员：Bharti R Daswani, MD, PhD、BJ Govt Medical College & Sassoon General Hospitals, Pune

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

2011年4月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2012年9月29日

首先提交符合 QC 标准的

2012年10月1日

首次发布 (估计)

2012年10月2日

研究记录更新

最后更新发布 (估计)

2012年10月2日

上次提交的符合 QC 标准的更新

2012年10月1日

最后验证

2012年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ND1210132-34
  • CTRI/2011/04/001698 (注册表标识符：Clinical Trials Registry of India)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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