EUCTR2016-004292-41-GR进行中（未招募）1 期
Therapeutic Equivalence (non-inferiority), Randomized, Observer-blind, two Parallel Group, Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Formulation of Vaginal Ovule containing Clindamycin 100 mg/ovule versus Dalacin® 100 mg Vaginal Ovules (Pfizer©) in patients with Bacterial Vaginosis - Therapeutic equivalence trial between two formulations of clindamycin 100mg vaginal ovules
Verisfield (UK) Ltd., Greek branch0 个研究点目标入组 292 人开始时间: 2017年1月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 292
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Inclusion Criteria:
- •In order to be included, subjects will have to meet all of the following criteria:
- •Pre- and post-menopausal women of any race and =18 years of age;
- •Diagnosis of bacterial vaginosis based on Amsel’s criteria: presence of at least 3 of the following four criteria: i) increased homogeneous thin vaginal discharge, ii) pH of the secretion greater than 4.5, iii) amine odor when potassium hydroxide 10% solution is added to a drop of vaginal secretions-whiff test and iv) presence of clue cells in wet preparations on microspcopy;
- •willing to refrain from using any vaginal product (e.g., spermicide, tampon, douche, diaphragm, or condom), other than study product, on study Days 1-6, for 48 hours prior to the first dose of study product, and for 48 hours prior to Test of Cure visit;
- •willing to refrain from sexual intercourse on study Days 1-3 and for 48 hours prior to Test of Cure visit;
- •able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
- •willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 292
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •Exclusion Criteria
- •In order to be included, subjects will have to meet none of the following criteria:
- •pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
- •menstruating when diagnosis of BV is determined at Baseline visit;
- •primary or secondary immunodeficiency;
- •severe liver disease;
- •history of regional enteritis, ulcerative colitis, or a history of antibiotic-associated” colitis;
- •current or past evidence of any vulvovaginitis other than bacterial vaginosis (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma virus);
- •subject will be under treatment during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma;
- •history of hypersensitivity to clindamycin, lincomycin, or any of the components of the formulation;
- •use within 2 weeks prior to baseline of topical or systemic antibiotics/antifungal;
- •use of spermicides, tampons, douches, diaphragms, condoms or other intra-vaginal product within 48 hours prior to dosing on study Day 1;
- •current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
- •unwillingness or inability to comply with the clinical trial procedures;
- •unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
- •who are legally incapacitated;
- •who are legally detained in an official institute.
研究者
相似试验
进行中（未招募）
不适用
This study will evaluate and confirm that the efficacy and tolerability of aNew Preservative-free Generic Formulation of Travoprost 40µg/ml Eye Drops isnot worse to the marketed preservative-containing formulationTravatan™ Eye Drops in Patients with Open Angle Glaucoma or OcularHypertensioOpen angle glaucoma or ocular hypertension.MedDRA version: 17.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2014-002576-91-GROmniVision GmbH
进行中（未招募）
1 期
This study will evaluate and confirm that the efficacy and tolerability of a New Preservative-free Generic Formulation of 0.2% Brimonidine/0.5% Timolol fixed-Combination Eye Drops solution in single dose container is not worse to the marketed preservative-containing formulation Combigan®Eye Drops solution in Patients with OpenAngle Glaucoma or Ocular Hypertension already on Treatment with IOP-lowering Drugs and Low Intraocular Pressure (IOP=21 mmHg)Open angle glaucoma or ocular hypertension.MedDRA version: 18.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2015-000160-34-GROmniVision GmbH
进行中（未招募）
1 期
This study will evaluate and confirm that the efficacy and tolerability of a new Preservative-free Generic Formulation of Latanoprost 50µg/ml Eye Drops solution in multiple dose container is not worse to the marketed preservative-containing formulation Xalatan®Eye Drops solution in Patients with Open Angle Glaucoma or Ocular HypertensioOpen angle glaucoma or ocular hypertension.MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-002910-29-GRPHARMATHE170
进行中（未招募）
1 期
This study will evaluate and confirm that the efficacy and tolerability of a new preservative-free generic formulation of Latanoprost l/Timolol (50µg+5mg)/ml Eye Drops solution is not worse to the marketed preservative-containing formulation Xalacom® Eye Drops solution in Patients with Open Angle Glaucoma or Ocular HypertensioOpen angle glaucoma or ocular hypertension.MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disordersMedDRA version: 20.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disordersMedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disordersEUCTR2017-004524-29-GRPHARMATHE210
进行中（未招募）
1 期
A Study for Comparing a Generic Combination of Brinzolamide and Timolol Eye Drops versus Azarga® Eye Drops in the Treatment of Patients with GlaucomaCTIS2023-506494-35-00OmniVision GmbH234