Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00141401
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00141401
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 17, 2007
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date August 17, 2007
Study Start Date  ICMJE September 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
Safety Efficacy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00141401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.
Official Title  ICMJE An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Brief Summary To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE Drug: Pregabalin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 31, 2005)
240
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141401
Other Study ID Numbers  ICMJE 1008-074
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP