A study to assess if gabapentine could prevent the postherpetic neuralgia in patient with Herpes zoster if treated the first 72 hour of the onset.

Efficacy and safety of gabapentin versus placebo to prevent the incidence of PostHerpetic Neuralgia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000521-31-ES

Enrollment

Unknown

Registered

2013-10-22

Start date

2013-12-26

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postherpetic Neuralgia MedDRA version: 14.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852

Interventions

Trade Name: GABAPENTINA KERN PHARMA Pharmaceutical Form: Capsule, hard INN or Proposed INN: GABAPENTINA CAS Number: 060142-096-3 Current Sponsor code: 781443 Other descriptive name: GABAPENTIN Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient aged >= 50 , diagnosed by uncomplicated herpes zoster with a =65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: Current or anticipated treatment with gabapentine or triciclys antidepresants Patients diagnosed of hepatic insufficiency Patients with a a history of intolerance of hipersensitivity to gabapentin or excipients. Patients with impaired renal function (Clcr 20 discrete lesion outside adjacent dermatomes) evidencia de diseminación cutánea o visceral del HZ (más de 20 lesiones fuera del dermatoma adyacente) Patients who have received inmunosupresive therapy in the last 3 months or inmunomodulatory medication (including interferon) within the previous 4 weeks Patient diagnosed of inmunodeficiency

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): percentage of patients without post-herpetic neuralgia at 6 weeks. percentage of patients with a reduction >= to 50% in the analogic visual analog scale of pain at 12 weeks. porcentage of patient with adverse events and adverse effect to the treatment. Patient SF-12 rating score at 6 and 12 weeks;Timepoint(s) of evaluation of this end point: 6 or 12 weeks as indicate above	—

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster in patients>= 50 years with moderate to severe pain added to the usual treatment to reduce the percentage of patients without post-herpetic neuralgia at 12 weeks.;Secondary Objective: To evaluate the efficacy of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster added to the usual treatment..... to reduce the percentage of patients without post-herpetic neuralgia at 6 weeks. to reduce the percentage of patients with a reduction >= to 50% in the analogic visual analog scale of pain at 12 weeks. To evaluate the security of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster added to the usual treatment in terms of porcentage of patient with adverse events and adverse effect to the treatment. To evaluate que quality of life by the SF-12 scale of patient treated with gabapentine compare to placebo patients.;Primary end point(s): Percentage of patients without post-herpetic neuralgia defined as a score of 0 in the visual analog scale of pain.;Timepoint(s) of evaluation of this end point: at 12 weeks from inclusion	—

Measure

Time frame

Main Objective: To evaluate the efficacy of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster in patients>= 50 years with moderate to severe pain added to the usual treatment to reduce the percentage of patients without post-herpetic neuralgia at 12 weeks.;Secondary Objective: To evaluate the efficacy of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster added to the usual treatment..... to reduce the percentage of patients without post-herpetic neuralgia at 6 weeks. to reduce the percentage of patients with a reduction >= to 50% in the analogic visual analog scale of pain at 12 weeks. To evaluate the security of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster added to the usual treatment in terms of porcentage of patient with adverse events and adverse effect to the treatment. To evaluate que quality of life by the SF-12 scale of patient treated with gabapentine compare to placebo patients.;Primary end point(s): Percentage of patients without post-herpetic neuralgia defined as a score of 0 in the visual analog scale of pain.;Timepoint(s) of evaluation of this end point: at 12 weeks from inclusion

—

Countries

Spain

Contacts

Public ContactDr. Joan Llobera Canavés

Research Unit/ Gerencia de Atención Primaria Mallorca

jllobera@ibsalut.caib.es0034971175883

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026