A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Healthy Clinical Trial

Official title:

A Randomised, Controlled, Single-blinded, Cross Over Comparison Study to Compare the Efficacy of the Rapydan Medicated Plaster Versus Tetracaine Gel

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00670696
• Other study ID #: RD 305/24674
• Status: Withdrawn
• Phase: Phase 4
• First received: April 29, 2008
• Last updated: April 24, 2012
• Start date: April 2008

Study information

• Verified date: April 2012
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively.

Description:

Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively. This study has been withdrawn and no additional data is available.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy male subjects of any race, 18 yrs or older

• No clinically significant findings on physical exam

• Signed informed consent

Exclusion Criteria:

• Damaged, denuded or broken skin at the designated site for application of the medicated plaster or gel.

• Know allergies to lidocaine, tetracaine or other local anaesthetics

• Concomitant use of prescription strength analgesics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Healthy

Intervention

Drug:
• Rapydan
Topical anaesthetic plaster
• tetracaine gel
Topical tetracaine gel

Locations

Country	Name	City	State
United Kingdom	Merthyr Tydfill Industrial Estate	Merthyr	Tydfill

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate superiority for Rapydan medicated plaster applied 30 minutes over tetracaine gel applied for 45 minutes in terms of reducing pain associated with venous cannulation as assessed by the subject on a 100 mm visual analog scale (VAS)		VAS post venous cannulation	No
Secondary	To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gel		Up to 14 days post exposure	No