Pregabalin Peripheral Neuropathic Pain Study

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NCT00141219

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Study Location
Pfizer Investigational Site
Sungnam-si, Gyeonggi-do, 463-802, Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Neuropathies, Neuralgia
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 peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.

- Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).

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


- Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain
(including post-surgical), that may confuse or confound the assessment of neuropathic
pain.


- Presence of any severe pain associated with conditions other than DPN, PHN, or
post-traumatic neuropathic pain (including post-surgical) that may confound the
assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic
neuropathic pain (including post-surgical).


- Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age,
and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for
subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day

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Diabetic Neuropathies, NeuralgiaPregabalin Peripheral Neuropathic Pain Study
NCT00141219
  1. Sungnam-si, Gyeonggi-do
  2. Suwonsi, Gyeonggi-do
  3. Busan,
  4. Daegu,
  5. Gwangju,
  6. Seoul,
  7. Seoul,
  8. Seoul,
  9. Seoul,
  10. Seoul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin Peripheral Neuropathic Pain Study
Official Title  ICMJE A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Peripheral Neuropathic Pain
Brief Summary To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Neuropathies
  • Neuralgia
Intervention  ICMJE
  • Drug: pregabalin
    150-600mg/day, BID
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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
Actual Enrollment  ICMJE
 (submitted: January 9, 2008)		241
Original Enrollment  ICMJE
 (submitted: August 30, 2005)		234
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
  • Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ?4 over the 7 days prior to Visit 2 (randomization).

Exclusion Criteria:

  • Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
  • Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
  • Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day
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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141219
Other Study ID Numbers  ICMJE A0081037
Has Data Monitoring Committee No
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 September 2009

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