Contact information
Type
Scientific
Primary contact
Dr AK Dashfield
ORCID ID
Contact details
Anaesthetic Department
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
+44 (0)1752 777111
adrian.dashfield@phnt.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185109366
Study information
Scientific title
Acronym
Study hypothesis
Patients will be randomised into two groups who present with chronic inguinodynia - gabapentin or placebo. A preliminary questionnaire will be administered and pain scores will be recorded. Patients will be supplied with either gabapentin or placebo in an increasing dose. Patients will be followed up at 4 weeks post treatment where questionnaires and pain scores will be repeated as well as perceived side effects of the treatment recorded.
Ethics approval
Not provided at time of registration
Study design
Randomised placebo-controlled blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Pain
Intervention
Patients will be randomised into two groups who present with chronic inguinodynia - gabapentin or placebo. A preliminary questionnaire will be administered and pain scores will be recorded. Patients will be supplied with either gabapentin or placebo in an increasing dose. Patients will be followed up at 4 weeks post treatment where questionnaires and pain scores will be repeated as well as perceived side effects of the treatment recorded.
Added 11/01/2010: trial stopped due to lack of funding
Intervention type
Drug
Phase
Not Applicable
Drug names
gabapentin
Primary outcome measures
That gabapentin, an anticonvulsant drug used in the treatment of neuropathic pain, significantly reduces pain in patients with inguinodynia.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2004
Overall trial end date
31/12/2004
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetic Department
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary