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Sponsored by: |
Endo Pharmaceuticals |
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Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00266214 |
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.
Condition | Intervention | Phase |
---|---|---|
Carpal Tunnel Syndrome |
Drug: lidocaine patch 5% |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 310 |
Study Start Date: | November 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Are males or females 18 years of age or older
Exclusion Criteria:
Study ID Numbers: | EN3272-301 |
Study First Received: | December 15, 2005 |
Last Updated: | March 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00266214 |
Health Authority: | United States: Food and Drug Administration |
lidocaine patch 5% Lidoderm carpal tunnel syndrome |
pain nerve compression injury topical analgesic |
Carpal Tunnel Syndrome Roussy Levy hereditary areflexic dystasia Charcot-Marie-Tooth Disease Lidocaine Wounds and Injuries Disorders of Environmental Origin Pain Mononeuropathies |
Nerve Compression Syndromes Tomaculous neuropathy Neuromuscular Diseases Peripheral Nervous System Diseases Hereditary Motor and Sensory Neuropathies Charcot Marie Tooth disease Cumulative Trauma Disorders Sprains and Strains |
Median Neuropathy Disease Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents Anesthetics, Local |
Pharmacologic Actions Pathologic Processes Sensory System Agents Therapeutic Uses Syndrome Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents |