The aim of this study is to determine the efficacy, safety and ease of use of Lidocaine Lozenges for the patient undergoing gastrointestinal endoscopy as compared to lidocaine spray.
- Conditions
- Health Condition 1: null- Diagnostic Gastro-duodenal Endoscopy
- Registration Number
- CTRI/2010/091/001217
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd Ahmedabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
1. Patients of either sex aged 18-80 years.
2. Patients undergoing diagnostic gastro-duodenal endoscopy.
1. Hypersensitivity to lidocaine or any component of the formulation.
2. Any contra-indication to lidocaine.
3. Application on breached mucous membrane.
4. Patients with medical history of respiratory disease such as asthma, bronchitis or chronic obstructive pulmonary disease.
5. Use of another topical product at application site.
6. Unwilling patients.
7. Emergency surgery/ surgery needing hospitalization.
8. H/O alcohol or drug abuse.
9. Clinically significant impairment of hepatic/renal/cardiac functions.
10. Baseline laboratory values outside the clinically acceptable limits.
11. Pregnant women and lactating mothers.
12. Women of child bearing age not practicing contraception.
13. Participation in a clinical study involving an investigational product within past 30 days.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method