Condition category
Nervous System Diseases
Date applied
29/01/2013
Date assigned
02/05/2013
Last edited
02/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Postherpetic neuralgia is thought to be nerve damage caused by herpes zoster virus. The damage causes nerves in the affected area of the skin to send abnormal electrical signals to the brain. Our goal is to analyse the efficacy of a drug gabapentin in patients 50 years old or above with moderate to severe pain during the acute phase of the herpes zoster in the prevention of the postherpetic neuralgia. The study's findings should help to reduce the percentage of patient that show postherpetic neuralgia during an episode of herpes zoster.

Who can participate?
Our study aims to recruit about 254 patient, both men and women aged 50 or above diagnosed or uncomplicated Herpes zoster within 72 hours of onset of the rash in patients with acute herpes zoster and with moderate/severe pain.

What does the study involve?
Over a period of one year participants will be invited to participate in the study. Participant will be invited to take gabapentin or placebo (dummy) for 5 weeks, the process to decide if a patient will take gabapentin or placebo to which will be decided by a process called ‘randomisation’, which is like a coin toss.
At the end of the study, we will compare the prevalence of postherpetic neuralgia in the placebo and gabapentin groups.

What are the possible benefits and risks of participating?
Gabapentin is an authorised drug by the European and American drugs agencies for the treatment of epilepsy and postherpetic neuralgia, both agencies has evaluated the safety of the gabapentin for the treatment of epilepsy and is not expected to be less safer in those patients with Herpes zoster. Patient treated with gabapentin for 5 weeks in the acute herpes zoster period plus valacyclovir and analgesic will reduce the incidence of postherpetic neuralgia by 25% compared to placebo.

Where is the study run from?
The study has been set up by the Primary Care Management of Mallorca.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start May-2013. Participants will be enrolled on the study for a period of one year and the final results are expected to be ready in November 2015.

Who is funding the study?
Funding has been provided by the Spanish Institue of Health Carlos III.

Who is the main contact?
Manel Rullán
mrullan@ibsalut.caib.es

Trial website

Contact information

Type

Scientific

Primary contact

Mr Manuel Rullan

ORCID ID

Contact details

Centro de Salud de Pollença; C/ BISBE DESBACH
S/N
Pollença
07460
Spain
aleiva@ibsalut.caib.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI12_01813

Study information

Scientific title

Efficacy and safety of gabapentin versus placebo to prevent the incidence of PostHerpetic Neuralgia: a double blinded clinical trial

Acronym

PHN

Study hypothesis

Patient treated with gabapentin for 5 weeks in the acute herpes zoster period plus valacyclovir and analgesic will reduce the incidence of postherpetic neuralgia by 25% when compared to placebo plus valacyclovir and analgesic.

Ethics approval

Illes Balears ethics committee - approval pending

Study design

Phase III multi-centre double blind placebo randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Postherpetic neuralgia

Intervention

Antiviral therapy is first-line treatment and should be initiated within 72 hours of rash onset to increase the rate of healing and decrease pain, valacyclovir is also effective in the prevention of the postherpetic neuralgia, placebo and gabapentin groups will receive 1g/8h the first week.

Pain management: The WHO three-step "ladder" will be used for pain management.
If pain occurs, there should be prompt oral administration of drugs in the following order: non opioids (aspirin and paracetamol); then, as necessary, mild opioids (codeine); then strong opioids such as morphine, until the patient is free of pain.

Gabapentin or placebo treatment: effective dose should be individualized according to patient response and tolerability. The treatment should be started at a dose of 900 mg/d (300 mg/d on day 1, 600 mg/d on day 2, and 900 mg/d on day 3), then every 2 or 3 day an increase of 300mg depending up to a maximum doses of 3600mg/day. The treatment will end at 5 weeks, in the last week gabapentin or placebo will be gradually tapered.

Intervention type

Drug

Phase

Phase III

Drug names

Gabapentin, valacyclovir

Primary outcome measures

Prevalence of postherpetic neuralgia at 12 weeks [Visual Analog Scale (VAS >0)]

Secondary outcome measures

1. Prevalence of postherpetic neuralgia at 6 weeks (VAS >0)
2. Percentage of patient with a reduction of at least 50% in the VAS scale.

Overall trial start date

15/05/2013

Overall trial end date

15/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient aged 50 or above, either sex
2. Patient diagnosed or uncomplicated herpes zoster within 72 hours of onset of the rash in patients with acute herpes zoster and with moderate/severe pain (Analogic visual scale ≥ 4)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

254 patients

Participant exclusion criteria

1. Patients taking gabapentin
2. Patients diagnosed of severe hepatic impairment, hypersensitivity to gabapentin or excipients, acute renal failure or renal impairment (Clcr <79ml/min)
3. Patients with evidence of cutaneous or visceral dissemination of herpes zoster infection (cutaneous dissemination is defined as 20 discrete lesions outside adjacent dermatomes) or ocular dissemination
4. Immunocompromised state and/or interferon treatment in the last 4 weeks
5. Patient taking tricyclic antidepressants or corticoids in the inclusion or treatment period

Recruitment start date

15/05/2013

Recruitment end date

15/11/2015

Locations

Countries of recruitment

Spain

Trial participating centre

Centro de Salud de Pollença; C/ BISBE DESBACH, S/N
Pollença
07460
Spain

Sponsor information

Organisation

Primary Care Management of Mallorca (Gerencia de Atención Primaria de Mallorca) (Spain)

Sponsor details

C/Reina Esclaramunda n 9
Palma de Mallorca
07003
Spain
jllobera@ibsalut.caib.es

Sponsor type

Government

Website

http://www.caib.es/govern/organigrama/area.do?coduo=1296290&lang=ca

Funders

Funder type

Hospital/treatment centre

Funder name

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) ref: PI12_01813

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