Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159666

Enrollment

255

Registered

2005-09-12

Start date

2004-10-31

Completion date

2006-06-30

Last updated

2021-01-22

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

Conditions

Post-Herpetic Neuralgia

Brief summary

The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

Interventions

DRUGpregabalin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion. * Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

Exclusion criteria

* History of neurolytic or neurosurgical therapy for PHN. * Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.

Design outcomes

Primary

Measure	Time frame
Onset meaningful pain reduction	—

Countries

Germany, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026