NCT01697826已完成4 期
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
Dr Bharti Daswani1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Primary outcome measure for Global effectiveness
研究概览
简要总结
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.
详细描述
- 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
- absence of any clinical sign suggestive of infective vaginitis and
- 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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
ClinSupV3 -soft gelatin capsule
Active Comparator
Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days
干预措施: ClinSupV3 -soft gelatin capsule (Drug)
ClinSupV3ER- Extended release tablet
Active Comparator
ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.
干预措施: ClinSupV3ER- Extended release tablet (Drug)
结局指标
主要结局
Primary outcome measure for Global effectiveness
时间窗: 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
次要结局
- Secondary outcome measures for Global effectiveness(29th day after initiation of treatment)
- Secondary outcome measures for tolerability(8th day after start of treatment)
研究者
Dr Bharti Daswani
Dr
Daswani, Bhart, M.D.
研究点 (1)
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