Not provided
Not provided
Not provided
Not provided
Not provided
Study was terminated for futility following the planned interim analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral tablet once a day dosing for 10 weeks. |
| |
| [S,S]-Reboxetine |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in weekly average pain score | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score) | 8 weeks | |
| Change from baseline in weekly average sleep interference scale | 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anniston | Alabama | 36207 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral tablet once a day dosing for 10 weeks. |
|
| Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory | 8 weeks |
| Modified Brief Pain Inventory-Short Form | 8 weeks |
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Pfizer Investigational Site | Mission Viejo | California | 92691 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80209 | United States |
| Pfizer Investigational Site | New Britain | Connecticut | 06050 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33609 | United States |
| Pfizer Investigational Site | Winter Haven | Florida | 33880 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40503 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40213 | United States |
| Pfizer Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| Pfizer Investigational Site | Jackson | Mississippi | 39202 | United States |
| Pfizer Investigational Site | Tupelo | Mississippi | 38801 | United States |
| Pfizer Investigational Site | Marionville | Missouri | 65705 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65807 | United States |
| Pfizer Investigational Site | Elizabeth | New Jersey | 07207 | United States |
| Pfizer Investigational Site | Hamilton | New Jersey | 08690 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14209 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | New York | New York | 10024 | United States |
| Pfizer Investigational Site | Cranston | Rhode Island | 02920 | United States |
| Pfizer Investigational Site | Cumberland | Rhode Island | 02864 | United States |
| Pfizer Investigational Site | Myrtle Beach | South Carolina | 29572 | United States |
| Pfizer Investigational Site | Bartlett | Tennessee | 38133 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77701 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77706 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-8858 | United States |
| Pfizer Investigational Site | Houston | Texas | 77079 | United States |
| Pfizer Investigational Site | Houston | Texas | 77081 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| Pfizer Investigational Site | Brno | 636 00 | Czechia |
| Pfizer Investigational Site | České Budějovice | 370 87 | Czechia |
| Pfizer Investigational Site | Ostrava | 702 00 | Czechia |
| Pfizer Investigational Site | Zlín | 760 01 | Czechia |
| Pfizer Investigational Site | Helsinki | 00290 | Finland |
| Pfizer Investigational Site | Kokkola | 67100 | Finland |
| Pfizer Investigational Site | Lahti | 15110 | Finland |
| Pfizer Investigational Site | Lohja | 08200 | Finland |
| Pfizer Investigational Site | Almere Stad | 1311 RL | Netherlands |
| Pfizer Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| Pfizer Investigational Site | Venlo | 5912 BL | Netherlands |
| Pfizer Investigational Site | Worcester | Cape Town | 6850 | South Africa |
| Pfizer Investigational Site | Bloemfontein | Free State | 9301 | South Africa |
| Pfizer Investigational Site | Ennerdale | Gauteng | 1820 | South Africa |
| Pfizer Investigational Site | Pretoria | Gauteng | 0204 | South Africa |
| Pfizer Investigational Site | Durban | KwaZulu-Natal | 4000 | South Africa |
| Pfizer Investigational Site | KwaDukuza | KwaZulu-Natal | 4450 | South Africa |
| Pfizer Investigational Site | Cape Town | 7130 | South Africa |
| Pfizer Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Pfizer Investigational Site | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Pfizer Investigational Site | Barcelona | 08035 | Spain |
| Pfizer Investigational Site | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Pontevedra | 36071 | Spain |
| Pfizer Investigational Site | Valencia | 46014 | Spain |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C524178 | O-methyl reboxetine |
Not provided
Not provided
Not provided