Gabapentin for Carpal Tunnel Syndrome

NCT00137735 | Completed Phase 3

• 1 other identifier: IG-HK-GAB-01-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; gabapentin

Outcome Measures

Primary Outcomes (1)

• Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks

  8 weeks

Secondary Outcomes (3)

• GSS at 2 weeks

  2 weeks

• Grip strength as functional assessment at 2 and 8 weeks

  2 weeks, 8 weeks

• Tolerability

  throughout subject's participation in trial

Study Arms (2)

1

ACTIVE COMPARATOR

Gabapentin

Drug: Gabapentin

2

PLACEBO COMPARATOR

Placebo

Other: placebo

Interventions

Gabapentin DRUG

300mg tds

1

placebo OTHER

tds

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Pfizer: collaborator

Study Sites (2)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

North District Hospital

Sheung Shui, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Andrew CF Hui, FHKAM

  Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: October 1, 2003
• Study Completion: December 1, 2006
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

HK (2)