A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

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NCT00156078

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Study Location
Pfizer Investigational Site
Buenos Aires, , , Argentina
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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

- Diagnosis of Type 1 or 2 diabetes mellitus.

- Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

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 any severe pain associated with conditions other than DPN that may confuse
or confound the assessment of neuropathic pain.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
Official Title  ICMJE A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
Brief Summary A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
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: September 7, 2005)		450
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Type 1 or 2 diabetes mellitus.
  • Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

Exclusion Criteria:

  • Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
  • Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
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 Argentina,   Brazil,   Chile,   Colombia,   Ecuador,   Indonesia,   Jordan,   Korea, Republic of,   Lebanon,   Malaysia,   Mexico,   Philippines,   Saudi Arabia,   Singapore,   Taiwan,   Thailand,   Turkey,   United Arab Emirates,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00156078
Other Study ID Numbers  ICMJE A0081030
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

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