A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

NCT00670696 | Withdrawn Phase 4

• 1 other identifier: RD 305/24674
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Anesthesia

Keywords

Topical anesthesia; Rapydan; Topical anaesthesia for venous cannulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gel

  Up to 14 days post exposure

Study Arms (2)

A

EXPERIMENTAL

Rapydan medicated plaster administered 30 minutes prior to cannulation on Visit 1 and tetracaine gel administered 45 minutes prior to cannulation on Visit 2.

Drug: Rapydan

B

ACTIVE COMPARATOR

Tetracaine gel administered 45 prior to cannulation on Visit 1 and then Rapydan administered 30 minutes prior to cannulation on Visit 1

Drug: tetracaine gel

Interventions

Rapydan DRUG

Topical anaesthetic plaster

A

tetracaine gel DRUG

Topical tetracaine gel

B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subjects of any race, 18 yrs or older
• No clinically significant findings on physical exam
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Merthyr Tydfill Industrial Estate

Merthyr, Tydfill, CF48 4DR, United Kingdom

Location

Study Officials

• Rahul Dimber, MD

  EUSA Pharma, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 2, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

GB (1)