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Pregabalin Peripheral Neuropathic Pain Study

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Sungnam-si, Gyeonggi-do, 463-802 Korea, Republic of
Contact
1-800-718-1021
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 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

NCT00141219
Pfizer
Completed
Pregabalin Peripheral Neuropathic Pain Study

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Pregabalin Peripheral Neuropathic Pain Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetic Neuropathies
  • Neuralgia
  • Drug: pregabalin
    150-600mg/day, BID
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00141219
A0081037
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the

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

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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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