A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
NCT ID: NCT00407745
Last Updated: 2021-01-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2007-01-31
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
NCT00978341
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
NCT01701362
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
NCT01202227
Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
NCT00159705
Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT00143156
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
matched placebo
placebo
Placebo
pregabalin
flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
pregabalin
Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo
Placebo
pregabalin
Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
* Pain score at least 4 in 4 of 7 days prior to receive treatment.
Exclusion Criteria
* Creatinine clearance \<60 mL/min.
* White blood cell count \<2500/mm3; neutrophil count \<1500/mm3; platelet count \<100 x 103/ mm3.
* Abuse of drugs or alcohol
* Unstable medial conditions
* Clinically significant abnormal electrocardiogram (ECG).
* Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Fresno, California, United States
Pfizer Investigational Site
Napa, California, United States
Pfizer Investigational Site
Northridge, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
White Plains, New York, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Bellevue, Ohio, United States
Pfizer Investigational Site
Johnstown, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Charleston, West Virginia, United States
Pfizer Investigational Site
Charleston, West Virginia, United States
Pfizer Investigational Site
Viña del Mar, Región de Valparaíso, Chile
Pfizer Investigational Site
Beijing, Beijing Municipality, China
Pfizer Investigational Site
Chengdu, Sichuan, China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Medellín, Antioquia, Colombia
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
Liberec, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Hong Kong, , Hong Kong
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Mangalore, Karnataka, India
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India
Pfizer Investigational Site
New Delhi, , India
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Daisen, Akita, Japan
Pfizer Investigational Site
Iizuka, Fukuoka, Japan
Pfizer Investigational Site
Fukuyama, Hiroshima, Japan
Pfizer Investigational Site
Bibai, Hokkaido, Japan
Pfizer Investigational Site
Hakodate, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Kobe, Hyōgo, Japan
Pfizer Investigational Site
Sasima-gun, Ibaraki, Japan
Pfizer Investigational Site
Kawasaki, Kanagawa, Japan
Pfizer Investigational Site
Kikuchi-gun, Kumamoto, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Kashiwazaki, Niigata, Japan
Pfizer Investigational Site
Beppu, Oita Prefecture, Japan
Pfizer Investigational Site
Hanyū, Saitama, Japan
Pfizer Investigational Site
Kitamoto, Saitama, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Kanuma, Tochigi, Japan
Pfizer Investigational Site
Kotoku, Tokyo, Japan
Pfizer Investigational Site
Musashimurayama-shi, Tokyo, Japan
Pfizer Investigational Site
Higashiokitama-gun, Yamagata, Japan
Pfizer Investigational Site
Chiba, , Japan
Pfizer Investigational Site
Tokushima, , Japan
Pfizer Investigational Site
Yamagata, , Japan
Pfizer Investigational Site
España, Manila, Philippines
Pfizer Investigational Site
Cebu City, , Philippines
Pfizer Investigational Site
Manila, , Philippines
Pfizer Investigational Site
Quezon City, , Philippines
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
Cardenas DD, Nieshoff EC, Suda K, Goto S, Sanin L, Kaneko T, Sporn J, Parsons B, Soulsby M, Yang R, Whalen E, Scavone JM, Suzuki MM, Knapp LE. A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury. Neurology. 2013 Feb 5;80(6):533-9. doi: 10.1212/WNL.0b013e318281546b. Epub 2013 Jan 23.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A0081107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.