CTRI/2021/04/032811已完成2 期
An open label, two treatment arm, active comparator controlled, pilot proof-of-concept academic clinical trial evaluating efficacy and safety of Levocloperastine 20mg/5ml oral suspension comparing with standard of care in patients with peripheral vertigo
Sanjivani Super Speciality Hospitals0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Able to provide written informed consent.
- •2 Able and willing to comply with the protocol, including availability for all scheduled study visits.
- •3 Males or non-pregnant females aged 18 years and above.
- •4. Patients diagnosed with peripheral vertigo of various origins based on:
- •ï?§History and clinical examinations [includes but not limited to symptoms, manual nystagmus assessment (horizontal and vertical movements), Rombergâ??s test, Hallpike (Baranyâ??s) maneuver], AND
- •ï?§Confirmed by presence of at least one vertigo symptom as being of at least medium intensity (>=2) on a 5-point VAS.
- •5 No history of addiction to any recreational drug or drug dependence or alcohol addiction.
- •6 Patients consent to use reliable contraceptive methods throughout the study and within 1 month after its completion. Persons eligible for participation in the study: Women who have a negative pregnancy test [Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation)] and use the following contraceptives: barrier method (condom or occlusive cap (diaphragm or cervical/vaulted cap)) or double barrier method of contraception (condom or occlusive cap (diaphragm or cervical/vaulted cap) plus spermicide (foam/gel/film/cream/suppository)). Women incapable of childbearing may also participate in the study (with past history of: hysterectomy, tubal ligation, infertility, menopause more than 1 year) or men with preserved reproductive function who use barrier contraceptives, as well as men with infertility or vasectomy in the past medical history.
排除标准
- •1 Known hypersensitivity to Levocloperastine or related class of drugs or to any of the excipients of the formulation.
- •2 Patient has a history of otosclerosis, vestibular schwannoma (based on history), or significant middle /inner ear / endolymphatic sac surgery in the affected ear.
- •3 Current conductive hearing loss, otitis media, or mixed hearing loss.
- •4 Patient has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- •5 Use of alcohol in the past 48 hours prior to screening.
- •6 Patient with vertigo of central or central with peripheral both in origin.
- •7 Patient with evidence of drug-induced vertigo.
- •8 Patient has orthostatic hypotension.
- •9 Patient has a history of vestibular migraine.
- •10 Have taken any drug for the treatment of peripheral vertigo in the last 15 days from screening.
- •11 Recent or concurrent use of any ototoxic medications (e.g. platinum compounds, loop diuretics or aminoglycosides) in the last 01 month from screening.
- •12 History or presence of significant uncontrolled concomitant diseases such as cardiovascular disease, hypertension, nervous system, any illness related to brain, Seizures, renal, hepatic, endocrine, hyperthyroidism,gastrointestinal, cervical spondylitis or pulmonary disease or other condition that would preclude patient participation.
- •13 AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000/microliter.
- •14 History of HIV or syphilis or hepatitis B and/or C.
- •15 Pregnant or nursing women or women planning pregnancy.
- •16 Patient has condition or is in a situation which, in the investigator opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patients participation in the study.
- •17 Patient unwillingness or inability to comply with procedures of the study protocol.
- •18 Patient had used an investigational drug or device in the 1 month prior to screening.
研究者
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