NCT01443325

Brief Summary

In the present placebo-controlled cross-over study the researchers intend to investigate analgesic and sensory effects of a lidocaine patch in patients with severe persistent inguinal post-herniorrhaphy pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

September 26, 2011

Last Update Submit

June 21, 2012

Conditions

Inguinal Pain

Keywords

Persistent Postherniorrhaphy inguinal Pain

Outcome Measures

Primary Outcomes (1)

  • pain reduction with lidocaine patch

    assessed the last three days in each treatment period

Study Arms (1)

lidocaine patch

EXPERIMENTAL
Drug: lidocaine patch

Interventions

lidocaine patchDRUG

1 patch for 12 hours within each 24 hours period

Also known as: versatis
lidocaine patch

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males \> 18 yrs
  • ASA (American Society´s of Anesthesiology´s classification) scores I-III, with severe Pain for more than six months and with average daily pain intensities (numerical rating scale \[NRS\] 0-10 points) during rest or during movement \> 6.

You may not qualify if:

  • History of an allergic reaction or intolerance to amide local anesthetics or vehicle ingredients in the patches
  • Use of class I antiarrhythmic drugs (e.g., tocainide and mexiletine)
  • Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
  • Inflamed or injured skin at the application site
  • Known severe hepatic disorder (Child-Pugh score \> 6)
  • Known severe renal impairment, (creatinine clearance \< 30 mL/min)
  • Signs of cognitive impairment or known drug or ethanol abuse during the last 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow, MD

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 29, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations

DK(1)