Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

NCT00143156

Last updated date
Study Location
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Neuropathies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females at least 18 years of age, of any ethnic origin

- Type 1 or 2 diabetes mellitus

- Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the
assessment of neuropathic pain.


- Presence of severe pain associated with conditions other than diabetic peripheral
neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathies
Intervention  ICMJE Drug: pregabalin
Study Arms  ICMJE Not Provided
Publications *

*   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)
450
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females at least 18 years of age, of any ethnic origin
  • Type 1 or 2 diabetes mellitus
  • Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

  • Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
  • Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
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 Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143156
Other Study ID Numbers  ICMJE A0081071
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 CenterPfizer
PRS Account Pfizer
Verification Date April 2008

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