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A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

This study has been withdrawn prior to enrollment.
(No longer sponsor of trial)
Sponsor:
Information provided by (Responsible Party):
EUSA Pharma (US), Inc.
ClinicalTrials.gov Identifier:
NCT00670696
First received: April 29, 2008
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
Anesthesia
 Drug: Rapydan
Drug: tetracaine gel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled, Single-blinded, Cross Over Comparison Study to Compare the Efficacy of the Rapydan Medicated Plaster Versus Tetracaine Gel

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EUSA Pharma (US), Inc.:

Primary Outcome Measures:
  • 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) [ Time Frame: VAS post venous cannulation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gel [ Time Frame: Up to 14 days post exposure ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Topical anaesthetic plaster
Active Comparator: B
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
Topical tetracaine gel

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670696

Locations
United Kingdom
Merthyr Tydfill Industrial Estate
Merthyr, Tydfill, United Kingdom, CF48 4DR
Sponsors and Collaborators
EUSA Pharma (US), Inc.
Investigators
Principal Investigator: Rahul Dimber, MD EUSA Pharma
  More Information

No publications provided

Responsible Party: EUSA Pharma (US), Inc.
ClinicalTrials.gov Identifier: NCT00670696     History of Changes
Other Study ID Numbers: RD 305/24674
Study First Received: April 29, 2008
Last Updated: April 24, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by EUSA Pharma (US), Inc.:
Topical anesthesia
Rapydan
Topical anaesthesia for venous cannulation

Additional relevant MeSH terms:
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013