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The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [S,S]-Reboxetine + Pregabalin | Experimental |
| |
| Pregabalin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [S,S]-Reboxetine + Pregabalin | Drug | [S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean endpoint (week 10) sleep interference score change from baseline | Week 10 | |
| Analysis of the Medical Outcomes Study Sleep Scale | Week 10 | |
| Analysis of the Patient Global Impression of Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Pregabalin | Drug | Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks |
|
| Week 10 |
| Analysis of the Neuropathic Pain Symptom Inventory | Week 10 |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Pfizer Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | United States |
| Pfizer Investigational Site | Amherst | New York | 14226 | United States |
| Pfizer Investigational Site | Orchard Park | New York | 14127 | United States |
| Pfizer Investigational Site | Kettering | Ohio | 45429 | United States |
| Pfizer Investigational Site | Vienna | A - 1090 | Austria |
| Pfizer Investigational Site | Calgary | Alberta | T3C 3P1 | Canada |
| Pfizer Investigational Site | Calgary | Alberta | T3E 0C5 | Canada |
| Pfizer Investigational Site | Edmonton | Alberta | T5A 4L8 | Canada |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 2H4 | Canada |
| Pfizer Investigational Site | Langley | British Columbia | V3A 4H9 | Canada |
| Pfizer Investigational Site | Greater Sudbury | Ontario | K3E 3L6 | Canada |
| Pfizer Investigational Site | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| Pfizer Investigational Site | Hawkesbury | Ontario | K6A 1A1 | Canada |
| Pfizer Investigational Site | North Bay | Ontario | P1B 2H3 | Canada |
| Pfizer Investigational Site | Val Caron | Ontario | P3N 1G3 | Canada |
| Pfizer Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1V 4X7 | Canada |
| Pfizer Investigational Site | Saint Romuald | Quebec | G6W 5M6 | Canada |
| Pfizer Investigational Site | Regina | Saskatchewan | S4P 3X1 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 7H9 | Canada |
| Pfizer Investigational Site | Sasktatoon | Saskatchewan | S7K 6Y6 | Canada |
| Pfizer Investigational Site | České Budějovice | 370 87 | Czechia |
| Pfizer Investigational Site | Pilsen | 304 60 | Czechia |
| Pfizer Investigational Site | Erbach im Odenwald | 64711 | Germany |
| Pfizer Investigational Site | Hattingen | 45525 | Germany |
| Pfizer Investigational Site | Jena | 07743 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76199 | Germany |
| Pfizer Investigational Site | Katzhütte | 98746 | Germany |
| Pfizer Investigational Site | Mainz | 55101 | Germany |
| Pfizer Investigational Site | Mainz | 55116 | Germany |
| Pfizer Investigational Site | München | 81675 | Germany |
| Pfizer Investigational Site | Münster | 48129 | Germany |
| Pfizer Investigational Site | Wiesbaden | 65189 | Germany |
| Pfizer Investigational Site | Milan | 20127 | Italy |
| Pfizer Investigational Site | Naples | 80138 | Italy |
| Pfizer Investigational Site | Perugia | 06123 | Italy |
| Pfizer Investigational Site | Riga | LV 1002 | Latvia |
| Pfizer Investigational Site | Breda | 4819 EV | Netherlands |
| Pfizer Investigational Site | Utrecht | 3584 CX | Netherlands |
| Pfizer Investigational Site | Bekkestua | 1319 | Norway |
| Pfizer Investigational Site | Lierskogen | N-3421 | Norway |
| Pfizer Investigational Site | Oslo | 0027 | Norway |
| Pfizer Investigational Site | Sandnes | 4313 | Norway |
| Pfizer Investigational Site | Trondheim | 7031 | Norway |
| Pfizer Investigational Site | Krakow | 31-531 | Poland |
| Pfizer Investigational Site | Poznan | 61-289 | Poland |
| Pfizer Investigational Site | Saint Petersburg | 194044 | Russia |
| Pfizer Investigational Site | Yaroslavl | 150030 | Russia |
| Pfizer Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Pfizer Investigational Site | Cadiz | 11009 | Spain |
| Pfizer Investigational Site | Granada | 18014 | Spain |
| Pfizer Investigational Site | Madrid | 28006 | Spain |
| Pfizer Investigational Site | Seville | 41013 | Spain |
| Pfizer Investigational Site | Valencia | 46014 | Spain |
| Pfizer Investigational Site | Eksjö | 575 81 | Sweden |
| Pfizer Investigational Site | Gothenburg | 413 45 | Sweden |
| Pfizer Investigational Site | Gothenburg | 416 85 | Sweden |
| Pfizer Investigational Site | Karlstad | 651 85 | Sweden |
| Pfizer Investigational Site | Skellefteå | 931 86 | Sweden |
| Pfizer Investigational Site | Stockholm | 114 54 | Sweden |
| Pfizer Investigational Site | Zurich | 8008 | Switzerland |
| Pfizer Investigational Site | Dnipropetrovsk | 49616 | Ukraine |
| Pfizer Investigational Site | Donetsk | 83045 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 310057 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61018 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61068 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61178 | Ukraine |
| Pfizer Investigational Site | Kyiv | 01021 | Ukraine |
| Pfizer Investigational Site | Kyiv | 04112 | Ukraine |
| Pfizer Investigational Site | Odesa | 65025 | Ukraine |
| Pfizer Investigational Site | Simferopol | 95006 | Ukraine |
| Pfizer Investigational Site | Uzhhorod | 88011 | Ukraine |
| Pfizer Investigational Site | Portsmouth | Hampshire | PO3 6AD | United Kingdom |
| Pfizer Investigational Site | London | UK | SE13 6LH | United Kingdom |
| Pfizer Investigational Site | Birmingham | West Midlands | B29 6JD | United Kingdom |
| Pfizer Investigational Site | Glasgow | G42 9YU | United Kingdom |
| Pfizer Investigational Site | London | EC1A 7BE | United Kingdom |
| Pfizer Investigational Site | Manchester | M8 5RB | United Kingdom |
| Pfizer Investigational Site | Plymouth | PL6 8DH | United Kingdom |
| Pfizer Investigational Site | York | YO31 8HE | United Kingdom |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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