Carpal Tunnel SyndromePhase 3NCT00266214
Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome
A Phase 3 study testing lidocaine patch 5% in people with Carpal Tunnel Syndrome, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine patch 5% compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- lidocaine patch 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are males or females 18 years of age or older
- Have confirmed diagnosis of CTS in one or both wrists. For patients with bilateral CTS, the most painful wrist will be identified as the "index" wrist, and will be the wrist used for all efficacy evaluations.
- Have clinical symptoms of pain, paresthesia, numbness and/or tingling in the distribution of the median nerve
- Have positive findings from electrodiagnostic tests using accepted criteria
- Have classification of the wrist(s) as "classic" or "probable" using the Katz Hand Diagram (Katz and Stirrat, 1990)
- Have worst daily pain intensity greater than 5 (0-10 scale) on approximately 75% of days over the previous 3 months; this criteria will be assessed at the screening visit only
- Have a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
- Have been informed of the nature of the study and provided written informed consent
Who cannot join
- Have a positive serum pregnancy test (females of childbearing potential only)
- Have tumors or cysts in the wrist, muscle wasting in the forearm and/or hand, peripheral neuropathy, mononeuropathy multiplex, or hand arthritis
- Have had previous CTS surgery
- Have severe CTS as defined by electrodiagnostic findings
- Have had steroid injections for CTS in the previous 3 months
- Have used diuretics (except a stable dose for hypertension) or Vitamin B6 or topical treatments for CTS (e.g., ultrasound, iontophoresis, cold laser) in the past 2 weeks
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- Require sleep medications
- Are using a lidocaine-containing product that cannot be discontinued during the study
- Have a known sensitivity or allergy to an amide-type local anesthetic agent para-aminobenzoic (PABA) derivatives or local anesthetics
- Have previously participated in a Lidoderm study
- Have severe renal insufficiency (creatinine clearance of <30 mL/min)
- Have moderate or greater hepatic impairment, including a history of or active hepatitis
- Have abnormal clinical laboratory test results unless deemed clinically insignificant by the investigator
- Have current or planned litigation, or who are planning to acquire or are currently receiving Worker's Compensation or Social Security benefits, or who, in the opinion of the investigator, exhibit any evidence of secondary gain (monetary or non-monetary) associated with carpal tunnel syndrome pain.
- Have a history of alcohol or substance abuse within the last 3 years
- Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days or 5 half-lives prior to receiving study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Study Comparing the Safety and Efficacy of the Lidocaine Patch 5% With Placebo in Patients With Pain From Carpal Tunnel Syndrome
The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine patch 5% compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome.
Read the detailed description
Patients with carpal tunnel syndrome (CTS)as determined by electrodiagnostic testing and moderate to severe pain will be randomized to receive either the lidocaine patch 5% or placebo patch q24h. The total duration of the double-blind treatment phase of the study will be 8 weeks.
At baseline and at periodic visits to the clinic, patients will perform pain and functionality assessments. Patients with bilateral CTS will identify the "index" wrist (i.e., the more painful wrist), which will subsequently be the wrist used for all efficacy assessments throughout the study.
Treatment Regimen and Route of Administration: Patients will apply one patch (either a lidocaine patch 5% or a matching placebo patch) to the volar aspect of each affected wrist once every 24 hours.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- lidocaine patch 5%
- Keywords
- lidocaine patch 5%, Lidoderm, carpal tunnel syndrome, pain, nerve compression injury, topical analgesic
- Medical subject headings
- Carpal Tunnel Syndrome, Pain, Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine patch 5%Drug
Also called Lidoderm
1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Patch 5% | Experimental | 1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime. Receives: Drug: lidocaine patch 5% |
| Placebo | Placebo comparator | 1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime. Receives: Drug: lidocaine patch 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst daily pain intensity score
Measured: Week 8
Secondary outcomes (6)
Average daily pain intensity score
Measured: Week 8
Levine CTS Symptom Severity and Functional Status Scales
Measured: Week 8
Mean interference with daily activities
Measured: Week 8
Intensity of Various Pain Qualities
Measured: Week 8
Quality of Sleep
Measured: Week 8
Global Assessment of Treatment Satisfaction and Impression of Change
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- PPD, Study director, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266214
- Sponsor's protocol ID
- EN3272-301
- Status last verified
- Jun 2011
- First submitted
- 15 Dec 2005
- Last updated
- 14 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study Comparing the Safety and Efficacy of the Lidocaine Patch 5% With Placebo in Patients With Pain From Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT00266214
- Acronym / sponsor ID
- EN3272-301
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- lidocaine patch 5%, Lidoderm, carpal tunnel syndrome, pain, nerve compression injury, topical analgesic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 16 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine patch 5% compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome.
Detailed description
Patients with carpal tunnel syndrome (CTS)as determined by electrodiagnostic testing and moderate to severe pain will be randomized to receive either the lidocaine patch 5% or placebo patch q24h. The total duration of the double-blind treatment phase of the study will be 8 weeks.
At baseline and at periodic visits to the clinic, patients will perform pain and functionality assessments. Patients with bilateral CTS will identify the "index" wrist (i.e., the more painful wrist), which will subsequently be the wrist used for all efficacy assessments throughout the study.
Treatment Regimen and Route of Administration: Patients will apply one patch (either a lidocaine patch 5% or a matching placebo patch) to the volar aspect of each affected wrist once every 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Patch 5% | Experimental | Drug: lidocaine patch 5%1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime. |
| Placebo | Placebo comparator | Drug: lidocaine patch 5%1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are males or females 18 years of age or older
- Have confirmed diagnosis of CTS in one or both wrists. For patients with bilateral CTS, the most painful wrist will be identified as the "index" wrist, and will be the wrist used for all efficacy evaluations.
- Have clinical symptoms of pain, paresthesia, numbness and/or tingling in the distribution of the median nerve
- Have positive findings from electrodiagnostic tests using accepted criteria
- Have classification of the wrist(s) as "classic" or "probable" using the Katz Hand Diagram (Katz and Stirrat, 1990)
Key exclusion criteria (16 listed)
- Have a positive serum pregnancy test (females of childbearing potential only)
- Have tumors or cysts in the wrist, muscle wasting in the forearm and/or hand, peripheral neuropathy, mononeuropathy multiplex, or hand arthritis
- Have had previous CTS surgery
- Have severe CTS as defined by electrodiagnostic findings
- Have had steroid injections for CTS in the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine patch 5%Also: Lidoderm1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime | Drug | Lidocaine Patch 5%, Placebo |
Primary outcome
Worst daily pain intensity score
Time frame: Week 8
6 secondary outcomes
Average daily pain intensity score
Time frame: Week 8
Levine CTS Symptom Severity and Functional Status Scales
Time frame: Week 8
Mean interference with daily activities
Time frame: Week 8
Intensity of Various Pain Qualities
Time frame: Week 8
Quality of Sleep
Time frame: Week 8
Global Assessment of Treatment Satisfaction and Impression of Change
Time frame: Week 8
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PPD study director
PPD Development, LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lidocaine patch 5% in people with Carpal Tunnel Syndrome, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst daily pain intensity score (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.