Diabetic Neuropathy, Painful Clinical Trial
Official title:
An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Verified date | August 2007 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.
Status | Completed |
Enrollment | 240 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must have met the inclusion criteria for preceding double-blind study - Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study. Exclusion Criteria: - Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind study, which was determined to be related to the study medication. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Pfizer |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Safety Efficacy |
Status | Clinical Trial | Phase | |
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