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.

An open label, comparative, multicentric study to evaluate efficacy and safety of lidocaine lozenges vs local lidocaine spray in patients undergoing diagnostic gastroduodenal endoscopy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/001217

Enrollment

250

Registered

2010-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diagnostic Gastro-duodenal Endoscopy

Interventions

Intervention1: Lidocaine Lozenges 200 mg: One unit to be administered 15-20 mins prior to the procedure. Control Intervention1: Lidocaine Spray: equivalent to 200 mg of lidocaine just prior to the pro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex aged 18-80 years. 2. Patients undergoing diagnostic gastro-duodenal endoscopy.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating;1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating;1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating;1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating	—

Measure

Time frame

1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating;1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating;1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating;1. Efficacy of topical analgesia as determined by ease of the procedure. 2. Level of gag refluxes 3. Physician global assessment of topical analgesia. 4. Ease of application of anaesthetic agent.Timepoint: Immediately after the procedure the investigator would fill in questionnaire rating

—

Secondary

Measure	Time frame
Need for sedationTimepoint: During study period ;Patients global assessment of topical anesthesiaTimepoint: At the end of the study;Systemic Adverse EventsTimepoint: During study period	—

Countries

India

Contacts

Public ContactDr Sanjay Maroo

Troikaa Pharmaceuticals Ltd.

sanjaymaroo@troikaapharma.com079-26856242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026