NCT00991068

Brief Summary

The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

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, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

October 6, 2009

Last Update Submit

March 14, 2012

Conditions

Carpal Tunnel Syndrome

Keywords

PainMild to moderate Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Screening/Day 1, Day 8, and Day 15 or early withdrawal

Secondary Outcomes (1)

  • Pain interference with activities (general, normal work, sleep)

    Screening/Day 1, Day 8, and Day 15 or early withdrawal

Study Arms (1)

Synera

EXPERIMENTAL

Synera topical patch

Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch

Interventions

Synera (lidocaine 70 mg and tetracaine 70 mg) topical patchDRUG

Patients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days.

Synera

Eligibility Criteria

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

You may qualify if:

  • Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
  • Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)

You may not qualify if:

  • Have bilateral carpal tunnel syndrome
  • Have another peripheral neuropathy in the affected limb
  • Have had an injection into the carpal tunnel within 8 weeks
  • Have had surgical release of the target wrist within previous 6 months
  • Have electrodiagnostic evidence of severe CTS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Clinical Research Institute

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromePain

Interventions

LidocaineTetracaineTransdermal Patch

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminespara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsEquipment and Supplies

Study Officials

  • Srinivas Nalamachu, MD

    International Clinical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 7, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

US(1)