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

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NCT00143156

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406 United States
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Contact
1-800-718-1021
[email protected]
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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.

NCT00143156
Pfizer
Completed
Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

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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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetic Neuropathies
Drug: pregabalin
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
May 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00143156
A0081071
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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