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Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nagoya, Aichi, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Painful Diabetic Neuropathy
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

- Visual Analogue Scale (VAS) of pain is higher than 40 mm.

- Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

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

- Malignancy within the past 2 years.

- Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment
of neuropathy pain

NCT00553475
Pfizer
Completed
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

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Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
  • Drug: placebo
    Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
  • Drug: pregabalin
    Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
  • Drug: pregabalin
    Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: Pregabalin 300 mg/day
    Intervention: Drug: pregabalin
  • Experimental: Pregabalin 600 mg/day
    Intervention: Drug: pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Visual Analogue Scale (VAS) of pain is higher than 40 mm.
  • Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

  • Malignancy within the past 2 years.
  • Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00553475
A0081163
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

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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[email protected]



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