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NCT00141401 Clinical Trial

Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.

Diabetic Neuropathy, Painful Clinical Trial

Official title:
An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141401
Other study ID # 1008-074
Secondary ID
Status Completed
Phase Phase 3
First received August 30, 2005
Last updated August 15, 2007
Start date September 1999
Est. completion date July 2005

Study information
Verified date August 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.

Recruitment information / eligibility
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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Efficacy
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