ABOUT THIS STUDY
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- 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).
- 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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Descriptive Information | ||||
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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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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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 | 241 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Director, Clinical Trials Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |