Diabetic Neuropathy, Painful Clinical Trial
Official title:
A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
| NCT number | NCT00156078 |
| Other study ID # | A0081030 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | January 2005 |
| Est. completion date | May 2007 |
| Verified date | March 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
| Status | Completed |
| Enrollment | 450 |
| Est. completion date | May 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Diagnosis of Type 1 or 2 diabetes mellitus. - Diagnosis of painful DPN for at least 12 months but less than 5 years in duration. Exclusion Criteria: - Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain. - Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain. |
| Country | Name | City | State |
|---|---|---|---|
| Pfizer Investigational Site | |||
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Brazil | Pfizer Investigational Site | Belo Horizonte | MG |
| Brazil | Pfizer Investigational Site | Niteroi | RJ |
| Chile | Pfizer Investigational Site | Providencia | Santiago |
| Chile | Pfizer Investigational Site | Valparaiso | V Region |
| Colombia | Pfizer Investigational Site | Bogotá | Cundinamarca |
| Colombia | Pfizer Investigational Site | Medellin | Antioquia |
| Ecuador | Pfizer Investigational Site | Quito | Pichincha |
| Indonesia | Pfizer Investigational Site | Jakarta Pusat | |
| Indonesia | Pfizer Investigational Site | Surabaya | |
| Jordan | Pfizer Investigational Site | Amman | |
| Korea, Republic of | Pfizer Investigational Site | Pusan | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Lebanon | Pfizer Investigational Site | Beirut | |
| Malaysia | Pfizer Investigational Site | Kuala Lumpur | |
| Mexico | Pfizer Investigational Site | Mexico Df | |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
| Mexico | Pfizer Investigational Site | San Luis Potosi | |
| Philippines | Pfizer Investigational Site | Espana | Manila |
| Philippines | Pfizer Investigational Site | Quezon City | |
| Saudi Arabia | Pfizer Investigational Site | Riyadh | |
| Singapore | Pfizer Investigational Site | Singapore | |
| Taiwan | Pfizer Investigational Site | Gueishan Shiang | Taoyan Hsien |
| Taiwan | Pfizer Investigational Site | Taipei | |
| Thailand | Pfizer Investigational Site | Khet Rajathevee | Bangkok |
| Thailand | Pfizer Investigational Site | Muang | Chiang MAI |
| Turkey | Pfizer Investigational Site | Ankara | |
| Turkey | Pfizer Investigational Site | Capa | Istanbul |
| Turkey | Pfizer Investigational Site | Istanbul | |
| Turkey | Pfizer Investigational Site | Izmir | |
| Turkey | Pfizer Investigational Site | Mersin | |
| United Arab Emirates | Pfizer Investigational Site | Abu Dhabi | |
| Venezuela | Pfizer Investigational Site | Caracas | Distrito Capital |
| Venezuela | Pfizer Investigational Site | El Hatillo | Caracas-Estado Miranda |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Argentina, Brazil, Chile, Colombia, Ecuador, Indonesia, Jordan, Korea, Republic of, Lebanon, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela,
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|---|---|---|---|---|
| Primary | Mean pain score |
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