Gabapentin for Carpal Tunnel Syndrome
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS). |
---|---|
Condition | Carpal Tunnel Syndrome |
Intervention | Drug: Gabapentin Other: placebo |
Phase | Phase 3 |
Sponsor | Chinese University of Hong Kong |
Responsible Party | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier | NCT00137735 |
First Received | August 29, 2005 |
Last Updated | October 30, 2007 |
Last verified | October 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | August 29, 2005 |
---|---|
Last Updated Date | October 30, 2007 |
Start Date | October 2003 |
Estimated Primary Completion Date | December 2006 |
Current Primary Outcome Measures | Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks [Time Frame: 8 weeks] |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Gabapentin for Carpal Tunnel Syndrome |
---|---|
Official Title | Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial |
Brief Summary | The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS). |
Detailed Description | A variety of treatment options exist at present for carpal tunnel syndrome (CTS) with no universal agreement. Recent reports suggested that untreated CTS might improve or remain stationary. In this respect, treatment directing towards symptom suppression alone may have a role in the initial management of CTS. Gabapentin (1-[aminomethyl]-cyclohexaneacetic acid; Neurontin, Pfizer) is an effective drug for treatment of neuropathic pain and has been reported to be effective in case series for the treatment of CTS with relatively benign side effects profile. The purpose of this study was to evaluate the safety and efficacy of gabapentin in the treatment of CTS. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Carpal Tunnel Syndrome |
Intervention | Drug: Gabapentin 300mg tds Other: placebo tds |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 150 |
Estimated Completion Date | December 2006 |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - Sensory symptoms over median nerve distribution for more than three months. - Confirmatory electrophysiologic results defined as prolonged median nerve distal motor latencies (DML) > 4 ms or median-ulnar palmer sensory latency differences > 0.5 ms. Exclusion Criteria: - Patients with evidence of severe CTS: fibrillation potentials or reinnervation on needle examination of the abductor pollicis brevis muscle or clinical examination showing wastage of the thenar muscles. (These patients were referred for surgical decompression on presentation.) - Clinical or electrophysiological evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as proximal median neuropathy, cervical radiculopathy, or significant polyneuropathy. - Known epilepsy. - Patients who have received previous steroid injection or oral steroid therapy for CTS. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Hong Kong |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00137735 |
---|---|
Other Study ID Numbers | IG-HK-GAB-01-02 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Chinese University of Hong Kong |
Study Sponsor | Chinese University of Hong Kong |
Collaborators | Pfizer |
Investigators | Principal Investigator: Andrew CF Hui, FHKAM Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong |
Verification Date | October 2007 |
Locations[ + expand ][ + ]
Prince of Wales Hospital | Shatin, New Territories, Hong Kong |
---|---|
North District Hospital | Sheung Shui, New Territories, Hong Kong |