Post-Herpetic Neuralgia Clinical Trial
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
| NCT number | NCT00159666 |
| Other study ID # | A0081004 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | October 2004 |
| Est. completion date | June 2006 |
| Verified date | November 2006 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia
| Status | Completed |
| Enrollment | 255 |
| Est. completion date | June 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Bochum | |
| Germany | Pfizer Investigational Site | Duesseldorf | |
| Germany | Pfizer Investigational Site | Frankfurt | |
| Germany | Pfizer Investigational Site | Goeppingen | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Hattingen | |
| Germany | Pfizer Investigational Site | Jena | |
| Germany | Pfizer Investigational Site | Nuernberg | |
| Germany | Pfizer Investigational Site | Wiesbaden | |
| Italy | Pfizer Investigational Site | L'Aquila | |
| Italy | Pfizer Investigational Site | Perugia | |
| Italy | Pfizer Investigational Site | Pisa | |
| Italy | Pfizer Investigational Site | Roma | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Granada | |
| Spain | Pfizer Investigational Site | Leganes | Madrid |
| Spain | Pfizer Investigational Site | Salamanca | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Valencia | |
| United Kingdom | Pfizer Investigational Site | Addlestone | Surrey |
| United Kingdom | Pfizer Investigational Site | Chicester | Sussex |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Middlesbrough | Cleveland |
| United Kingdom | Pfizer Investigational Site | Oldham, Lancashire | |
| United Kingdom | Pfizer Investigational Site | Portsmouth | |
| United States | Pfizer Investigational Site | Allentown | Pennsylvania |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Duarte | California |
| United States | Pfizer Investigational Site | Flowood | Mississippi |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Madison | Wisconsin |
| United States | Pfizer Investigational Site | Oak Brook | Illinois |
| United States | Pfizer Investigational Site | Palm Beach Gardens | Florida |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States, Germany, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Onset meaningful pain reduction |
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