Carpal Tunnel SyndromePhase 3NCT00137735
Gabapentin for Carpal Tunnel Syndrome
A Phase 3 study testing Gabapentin in people with Carpal Tunnel Syndrome, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS). 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?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesHong Kong
- Study dates
- Oct 2003to Dec 2006
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Prince of Wales Hospital
Shatin, New Territories
North District Hospital
Sheung Shui, New Territories
About this study
Official title: Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial
The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Gabapentin, placebo
- Keywords
- carpal tunnel syndrome, gabapentin
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
300mg tds
placeboOther
tds
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gabapentin Receives: Drug: Gabapentin |
| 2 | Placebo comparator | Placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks
Measured: 8 weeks
Secondary outcomes (3)
GSS at 2 weeks
Measured: 2 weeks
Grip strength as functional assessment at 2 and 8 weeks
Measured: 2 weeks, 8 weeks
Tolerability
Measured: throughout subject's participation in trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startOct 2003
- Study completionDec 2006
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Andrew CF Hui, FHKAM, Principal investigator, Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137735
- Sponsor's protocol ID
- IG-HK-GAB-01-02
- Status last verified
- Oct 2007
- First submitted
- 29 Aug 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00137735
- Acronym / sponsor ID
- IG-HK-GAB-01-02
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, gabapentin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Aug 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GabapentinGabapentin |
| 2 | Placebo comparator | Other: placeboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Gabapentin300mg tds | Drug | 1 |
| placebotds | Other | 2 |
Primary outcome
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks
Time frame: 8 weeks
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Andrew CF Hui, FHKAM principal investigator
Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Carpal Tunnel Syndrome, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks (time frame: 8 weeks). 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 31 Oct 2007.