To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.

Neuralgia Clinical Trial

Official title:

An Open-Label Extension Safety and Efficacy Study of Pregabalin in Patients With Postherpetic Neuralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150436
• Other study ID #: 1008-198
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: December 20, 2006
• Start date: February 2002
• Est. completion date: July 2005

Study information

• Verified date: December 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have met the inclusion criteria for preceding double-blind BID study in postherpetic neuralgia

• Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion Criteria:

• Patients cannot participate if they experienced a serious adverse event during preceding double-blind BID study which was determined to be related to the study medication.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

Drug:
• Pregabalin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Efficacy