Pain Clinical Trial
Official title:
[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.
| Verified date | December 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN
| Status | Terminated |
| Enrollment | 136 |
| Est. completion date | October 11, 2007 |
| Est. primary completion date | October 4, 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients must have pain present for more than 3 months after the healing of shingles skin rash - Patients at screening must have a score >/=40 mm on the pain visual analogue scale Exclusion Criteria: - Patients with significant renal and hepatic impairment - Patients with other severe pain, that may impair the self-assessment of the pain due to shingles - Patients with clinically abnormal electrocardiogram |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Pfizer Investigational Site | Wien | |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Hawkesbury | Ontario |
| Canada | Pfizer Investigational Site | Kelowna | British Columbia |
| Canada | Pfizer Investigational Site | Langley | British Columbia |
| Canada | Pfizer Investigational Site | North Bay | Ontario |
| Canada | Pfizer Investigational Site | Pointe-Claire | Quebec |
| Canada | Pfizer Investigational Site | Quebec | |
| Canada | Pfizer Investigational Site | Regina | Saskatchewan |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Sasktatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | St-Romuald | Quebec |
| Canada | Pfizer Investigational Site | Sudbury | Ontario |
| Canada | Pfizer Investigational Site | Sudbury | Ontario |
| Canada | Pfizer Investigational Site | Val Caron | Ontario |
| Czechia | Pfizer Investigational Site | Ceske Budejovice | |
| Czechia | Pfizer Investigational Site | Plzen | |
| Germany | Pfizer Investigational Site | Erbach | |
| Germany | Pfizer Investigational Site | Hattingen | |
| Germany | Pfizer Investigational Site | Jena | |
| Germany | Pfizer Investigational Site | Karlsruhe | |
| Germany | Pfizer Investigational Site | Katzhuette | |
| Germany | Pfizer Investigational Site | Mainz | |
| Germany | Pfizer Investigational Site | Mainz | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Germany | Pfizer Investigational Site | Muenster | |
| Germany | Pfizer Investigational Site | Wiesbaden | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Perugia | |
| Latvia | Pfizer Investigational Site | Riga | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Norway | Pfizer Investigational Site | Bekkestua | |
| Norway | Pfizer Investigational Site | Lierskogen | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Sandnes | |
| Norway | Pfizer Investigational Site | Trondheim | |
| Poland | Pfizer Investigational Site | Krakow | |
| Poland | Pfizer Investigational Site | Poznan | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Russian Federation | Pfizer Investigational Site | Yaroslavl | |
| Spain | Pfizer Investigational Site | Cadiz | |
| Spain | Pfizer Investigational Site | Granada | |
| Spain | Pfizer Investigational Site | L'hospitalet de Llobregat | Barcelona |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Valencia | |
| Sweden | Pfizer Investigational Site | Eksjo | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Karlstad | |
| Sweden | Pfizer Investigational Site | Skelleftea | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Switzerland | Pfizer Investigational Site | Zurich | |
| Ukraine | Pfizer Investigational Site | Dnipropetrovsk | |
| Ukraine | Pfizer Investigational Site | Donetsk | |
| Ukraine | Pfizer Investigational Site | Kharkiv | |
| Ukraine | Pfizer Investigational Site | Kharkiv | |
| Ukraine | Pfizer Investigational Site | Kharkiv | |
| Ukraine | Pfizer Investigational Site | Kharkiv | |
| Ukraine | Pfizer Investigational Site | Kyiv | |
| Ukraine | Pfizer Investigational Site | Kyiv | |
| Ukraine | Pfizer Investigational Site | Odessa | |
| Ukraine | Pfizer Investigational Site | Simferopol | |
| Ukraine | Pfizer Investigational Site | Uzhgorod | |
| United Kingdom | Pfizer Investigational Site | Birmingham | West Midlands |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | UK |
| United Kingdom | Pfizer Investigational Site | Manchester | |
| United Kingdom | Pfizer Investigational Site | Plymouth | |
| United Kingdom | Pfizer Investigational Site | Portsmouth | Hampshire |
| United Kingdom | Pfizer Investigational Site | York | |
| United States | Pfizer Investigational Site | Amherst | New York |
| United States | Pfizer Investigational Site | Gilbert | Arizona |
| United States | Pfizer Investigational Site | Huntsville | Alabama |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | North Dartmouth | Massachusetts |
| United States | Pfizer Investigational Site | Orchard Park | New York |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Austria, Canada, Czechia, Germany, Italy, Latvia, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated | Week 10 | ||
| Secondary | The mean endpoint (week 10) sleep interference score change from baseline | Week 10 | ||
| Secondary | Analysis of the Medical Outcomes Study Sleep Scale | Week 10 | ||
| Secondary | Analysis of the Patient Global Impression of Change | Week 10 | ||
| Secondary | Analysis of the Neuropathic Pain Symptom Inventory | Week 10 |
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