A Phase-IV, Prospective, Single-Arm, Multicenter Study to Determine the Safety and Effectiveness of Lidocaine (Xylocaine) 2% Viscous Solution - NA

Dr Reddys Laboratories Ltd0 个研究点目标入组 386 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•1. Male or non-pregnant, non-lactating female subject, aged more than or equal to 18 and less than or equal to 65 years, at the time of screening visit.
•2. Subject who require lidocaine 2% Viscous Solution either for 1) Irritated or inflamed mucous membranes of the mouth or pharynx OR 2) for reducing gagging during the taking of X-ray pictures and dental impressions.
•3. Subject is willing and able to provide written informed consent prior to study.
•4. Subject is willing and able to take the assigned study medication as directed, and comply with all the study procedures.

•1. Subjects who are pregnant, breast feeding, or planning a pregnancy within the study participation period.
•2. Hypersensitivity to lidocaine or any component of the formulation or to local anaesthetics of the amide type.
•3. Participation in a clinical study involving an investigational product within past 30 days.
•4. History of alcohol or drug abuse in the past 1 year.
•5. Clinically significant impairment of hepatic/renal/cardiac functions (e.g. heart block, myocardial infarction, severe shock) as per investigator discretion.
•6. Known history of human immunodeficiency virus, Hepatitis B virus (active or carrier of Hepatitis B), or Hepatitis C virus infection.
•7. Known sepsis or severely traumatized mucosa in the area of application.
•8. Institutionalized subjects.
•9. Subject with history of or active neurological disorder including seizures.
•10. Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.

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