Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Conditions
Interventions
Intervention1: Lidocaine (Xylocaine) 2% viscous solution: For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse events (TEAEs).Timepoint: Baseline to End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Visual Analog Scale (VAS) score for pain for Subjects with irritated or inflamed mucous membranes of the mouth and pharynxTimepoint: Baseline to each planned visit;Change in Visual Analog Scale (VAS) score for pain with irritated or inflamed mucous membrane of the mouth and pharynxTimepoint: Baseline to 10 and 30 minutes after first dose of Investigational Product (IP) administration.;Proportion of subjects in which investigator assessed completion of dental procedure as either excellent or good.Timepoint: Baseline visit;Proportion of subjects who rated reduction of gag reflex as either excellent or good.Timepoint: Baseline visit | — |
Countries
India
Contacts
Public ContactColette Pinto
Dr. Reddys Laboratories Ltd.
Outcome results
None listed