Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/01/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes