Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00159666
Collaborator
(none)
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40
20
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Study Details
Study Description
Brief Summary
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Oct 1, 2004
Study Completion Date
:
Jun 1, 2006
Outcome Measures
Primary Outcome Measures
- Onset meaningful pain reduction []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Phoenix | Arizona | United States | |
| 2 | Pfizer Investigational Site | Little Rock | Arkansas | United States | |
| 3 | Pfizer Investigational Site | Duarte | California | United States | |
| 4 | Pfizer Investigational Site | Denver | Colorado | United States | |
| 5 | Pfizer Investigational Site | Palm Beach Gardens | Florida | United States | |
| 6 | Pfizer Investigational Site | Oak Brook | Illinois | United States | |
| 7 | Pfizer Investigational Site | Flowood | Mississippi | United States | |
| 8 | Pfizer Investigational Site | Saint Louis | Missouri | United States | |
| 9 | Pfizer Investigational Site | Toledo | Ohio | United States | |
| 10 | Pfizer Investigational Site | Portland | Oregon | United States | |
| 11 | Pfizer Investigational Site | Allentown | Pennsylvania | United States | |
| 12 | Pfizer Investigational Site | Houston | Texas | United States | |
| 13 | Pfizer Investigational Site | Seattle | Washington | United States | |
| 14 | Pfizer Investigational Site | Madison | Wisconsin | United States | |
| 15 | Pfizer Investigational Site | Berlin | Germany | ||
| 16 | Pfizer Investigational Site | Bochum | Germany | ||
| 17 | Pfizer Investigational Site | Duesseldorf | Germany | ||
| 18 | Pfizer Investigational Site | Frankfurt | Germany | ||
| 19 | Pfizer Investigational Site | Goeppingen | Germany | ||
| 20 | Pfizer Investigational Site | Hamburg | Germany | ||
| 21 | Pfizer Investigational Site | Hattingen | Germany | ||
| 22 | Pfizer Investigational Site | Jena | Germany | ||
| 23 | Pfizer Investigational Site | Nuernberg | Germany | ||
| 24 | Pfizer Investigational Site | Wiesbaden | Germany | ||
| 25 | Pfizer Investigational Site | L'Aquila | Italy | ||
| 26 | Pfizer Investigational Site | Perugia | Italy | ||
| 27 | Pfizer Investigational Site | Pisa | Italy | ||
| 28 | Pfizer Investigational Site | Roma | Italy | ||
| 29 | Pfizer Investigational Site | Leganes | Madrid | Spain | |
| 30 | Pfizer Investigational Site | Barcelona | Spain | ||
| 31 | Pfizer Investigational Site | Granada | Spain | ||
| 32 | Pfizer Investigational Site | Salamanca | Spain | ||
| 33 | Pfizer Investigational Site | Sevilla | Spain | ||
| 34 | Pfizer Investigational Site | Valencia | Spain | ||
| 35 | Pfizer Investigational Site | Middlesbrough | Cleveland | United Kingdom | |
| 36 | Pfizer Investigational Site | Addlestone | Surrey | United Kingdom | |
| 37 | Pfizer Investigational Site | Chicester | Sussex | United Kingdom | |
| 38 | Pfizer Investigational Site | Glasgow | United Kingdom | ||
| 39 | Pfizer Investigational Site | Oldham, Lancashire | United Kingdom | ||
| 40 | Pfizer Investigational Site | Portsmouth | United Kingdom |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00159666
Other Study ID Numbers:
- A0081004
First Posted:
Sep 12, 2005
Last Update Posted:
Jan 22, 2021
Last Verified:
Nov 1, 2006