Efficacy and safety of gabapentin versus placebo to prevent the incidence of postherpetic neuralgia
| ISRCTN | ISRCTN79871784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79871784 |
| Protocol serial number | PI12_01813 |
| Sponsor | Primary Care Management of Mallorca (Gerencia de Atención Primaria de Mallorca) (Spain) |
| Funder | Instituto de Salud Carlos III (ref: PI12_01813) |
- Submission date
- 29/01/2013
- Registration date
- 02/05/2013
- Last edited
- 06/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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. The aim of this study 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?
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?
Participants are randomly allocated to take either gabapentin or placebo (dummy drug) for 5 weeks. At the end of the study, the prevalence of postherpetic neuralgia is compared in the placebo and gabapentin groups.
What are the possible benefits and risks of participating?
Gabapentin is an drug authorised 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. Patients 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?
Primary Care Management of Mallorca
When is the study starting and how long is it expected to run for?
May 2013 to November 2015.
Who is funding the study?
Institute of Health Carlos III (Spain)
Who is the main contact?
Manel Rullán
mrullan@ibsalut.caib.es
Contact information
Scientific
Centro de Salud de Pollença; C/ BISBE DESBACH, S/N
Pollença
07460
Spain
| aleiva@ibsalut.caib.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase III multi-centre double-blind placebo randomized clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy and safety of gabapentin versus placebo to prevent the incidence of PostHerpetic Neuralgia: a double-blinded clinical trial |
| Study acronym | PHN |
| Study objectives | 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(s) | Illes Balears ethics committee - approval pending |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Gabapentin, valacyclovir |
| Primary outcome measure(s) |
Prevalence of postherpetic neuralgia, assessed using the Visual Analog Scale (VAS >0) at 12 weeks |
| Key secondary outcome measure(s) |
1. Prevalence of postherpetic neuralgiaa, assessed using the Visual Analog Scale (VAS >0) at 6 weeks |
| Completion date | 15/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 254 |
| Total final enrolment | 98 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 15/05/2013 |
| Date of final enrolment | 15/11/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
07460
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/06/2019 | 06/06/2019 | Yes | No |
| Protocol article | protocol | 14/01/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
16/01/2017: Publication reference added.
