Phase 1 clinical trial of slow-release lidocaine sheet on normal mucous membrane

Phase 1 clinical trial of slow-release lidocaine sheet on normal mucous membrane - Phase 1 clinical trial of slow-release lidocaine sheet

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008248

Enrollment

Registered

2012-06-25

Start date

2012-08-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Healthy male subjects

Interventions

40% slow-release lidocaine 50mg

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. A person who has a enough understanding and a consent to the trial 2. A person has no anatomical disorders and no diseases inside those nasal cavities

Exclusion criteria

Exclusion criteria: 1. A person takes some medicine or remain an effect of stopped medicines 2. A person has an allergy to lidocaine and anesthetics kindred with lidocaine 3. A person has arrhythmia on ECG 4. A person is not conscious enough to evaluate correctly or not able to communicate 5. A person is judged unsuitable for the trial by a doctor

Design outcomes

Primary

Measure	Time frame
Ascertaining adverse events and side effects	—

Secondary

Measure	Time frame
Examining analgesic effects and operative hours with the von frey test	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026