Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
NCT ID: NCT00313820
Last Updated: 2021-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
220 participants
INTERVENTIONAL
2006-08-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pregabalin
The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.
Pregabalin
Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Placebo
The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.
Placebo
Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Interventions
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Pregabalin
Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Placebo
Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diabetic Peripheral Neuropathy (DPN)
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Darlinghurst, New South Wales, Australia
Pfizer Investigational Site
East Gosford, New South Wales, Australia
Pfizer Investigational Site
St Leonards, New South Wales, Australia
Pfizer Investigational Site
Warrawong, New South Wales, Australia
Pfizer Investigational Site
Herston, Queensland, Australia
Pfizer Investigational Site
Footscray, Victoria, Australia
Pfizer Investigational Site
Perth, Western Australia, Australia
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Guangzhou, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
New Territories, , Hong Kong
Pfizer Investigational Site
Bangalore, , India
Pfizer Investigational Site
Bangalore, , India
Pfizer Investigational Site
Chennai, , India
Pfizer Investigational Site
Lucknow, , India
Pfizer Investigational Site
New Delhi, , India
Pfizer Investigational Site
Jakarta, , Indonesia
Pfizer Investigational Site
Surabaya, , Indonesia
Pfizer Investigational Site
George Town, , Malaysia
Pfizer Investigational Site
Kuala Lumpur, , Malaysia
Pfizer Investigational Site
Kuala Selangor, , Malaysia
Pfizer Investigational Site
Karachi, Sindh, Pakistan
Pfizer Investigational Site
Karachi, , Pakistan
Pfizer Investigational Site
Manila, , Philippines
Pfizer Investigational Site
Manila, , Philippines
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Gueishan Shiang, Taoyuan Hsien, Taiwan
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Ratchatewee, Bangkok, Thailand
Pfizer Investigational Site
Bangkok, , Thailand
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081063
Identifier Type: -
Identifier Source: org_study_id
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