A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

Pfizer

Status and phase: Completed; Phase 2

Conditions: Postherpetic Neuralgia

Treatments: Drug: Placebo; Drug: pregabalin; Drug: pregabalin/PF-00489791

Study type: Interventional

Funder types: Industry

Identifiers

NCT00599638

B0261002

Details and patient eligibility

About

Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of non-childbearing potential
• Pain present for more than 3 months after healing of herpes zoster skin rash
• VAS score of >=40mm at screening and baseline visits

Exclusion criteria

• Patients with pain conditions which might impair the assessment of postherpetic neuralgia
• Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
• History or diagnosis of DSM IV major depressive disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: pregabalin

2

Experimental group

Treatment:

Drug: pregabalin/PF-00489791

3

Placebo Comparator group

Treatment:

Drug: Placebo