Clinical Trials Logo
  1. Home
  2. Diabetic Neuropathy, Painful
  3. NCT00150423
  4. Details
NCT00150423 Clinical Trial

To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful 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 NCT00150423
Other study ID # 1008-165
Secondary ID
Status Completed
Phase Phase 3
First received September 6, 2005
Last updated December 28, 2006
Start date January 2001
Est. completion date July 2005

Study information
Verified date December 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.

Recruitment information / eligibility
Status Completed
Enrollment 384
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 the preceding double-blind BID study in painful diabetic peripheral neuropathy

- Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion Criteria:

- Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID 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
See also
  Status Clinical Trial Phase
Completed NCT04988321 - Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms N/A
Completed NCT00385671 - An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain Phase 4
Completed NCT00159679 - Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy Phase 4
Completed NCT00141401 - Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy. Phase 3
Active, not recruiting NCT04469270 - Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy Phase 3
Completed NCT00553475 - Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy Phase 3
Completed NCT00381719 - Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy Phase 2
Completed NCT00539175 - Treatment of Painful Diabetic Neuropathy With Photon Stimulation N/A
Completed NCT00058968 - A Study for the Treatment of Painful Diabetic Neuropathy Phase 3
Completed NCT05029297 - Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy. Phase 3
Completed NCT02215252 - A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN) Phase 2
Completed NCT00785577 - A Study for Treatment of Pain in Patients With Diabetic Neuropathy. Phase 2
Completed NCT00858351 - Thermal Biofeedback for the Treatment of Diabetic Neuropathy N/A
Completed NCT03047278 - Transporters for Organic Cations and Glycemic Control in Patients With Neuropathic Pain. Phase 4
Completed NCT01628627 - Frequency Modulated Neural Stimulation (FREMS) in Symptomatic Diabetic Neuropathy Phase 4
Completed NCT03315598 - Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain N/A
Completed NCT01057693 - Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy Phase 3
Completed NCT01564459 - Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021) Phase 2
Recruiting NCT01214590 - Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy N/A
Completed NCT01089556 - A Study in Painful Diabetic Neuropathy Phase 3