Clinical trial NCT00159666: Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Herpetic Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Onset meaningful pain reduction
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Duarte
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Palm Beach Gardens
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Oak Brook
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Goeppingen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hattingen
country: Germany
facility: Pfizer Investigational Site
city: Jena
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: L'Aquila
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Leganes
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Salamanca
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Middlesbrough
country: United Kingdom
facility: Pfizer Investigational Site
state: Cleveland
city: Addlestone
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Chicester
country: United Kingdom
facility: Pfizer Investigational Site
state: Sussex
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Oldham, Lancashire
country: United Kingdom
facility: Pfizer Investigational Site
city: Portsmouth
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
citation: Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.