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Gabapentin for Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137735
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : October 31, 2007
Sponsor:
Collaborator:
Pfizer
Information provided by:
Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date October 31, 2007
Study Start Date  ICMJE October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Global Symptom Score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
  • GSS at 2 weeks [ Time Frame: 2 weeks ]
  • Grip strength as functional assessment at 2 and 8 weeks [ Time Frame: 2 weeks, 8 weeks ]
  • Tolerability [ Time Frame: throughout subject's participation in trial ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
  • 1) GSS at 2 weeks
  • 2) Grip strength as functional assessment at 2 and 8 weeks
  • 3) Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gabapentin for Carpal Tunnel Syndrome
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Drug: Gabapentin
    300mg tds
  • Other: placebo
    tds
Study Arms  ICMJE
  • Active Comparator: 1
    Gabapentin
    Intervention: Drug: Gabapentin
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137735
Other Study ID Numbers  ICMJE IG-HK-GAB-01-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Andrew CF Hui, FHKAM Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP