A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00407745

Recruitment Status : Completed

First Posted : December 5, 2006

Results First Posted : December 8, 2011

Last Update Posted : January 25, 2021

Sponsor:

Information provided by (Responsible Party):

Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

Brief Summary:

The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.

Condition or disease	Intervention/treatment	Phase
Neuralgia Spinal Cord Injuries	Drug: placebo Drug: pregabalin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury
Study Start Date :	January 2007
Actual Primary Completion Date :	February 2011
Actual Study Completion Date :	February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Pregabalin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: matched placebo	Drug: placebo Placebo
Experimental: pregabalin flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period	Drug: pregabalin Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day) Other Name: Lyrica

Outcome Measures

Primary Outcome Measures :

Duration Adjusted Average Change (DAAC) of Mean Pain Score [ Time Frame: Baseline, Week 16 ]
DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.

Secondary Outcome Measures :

Change From Baseline in Weekly Mean Pain Score [ Time Frame: Baseline, Week 16 ]
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline [ Time Frame: Baseline, Week 16 ]
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) [ Time Frame: Baseline, Week 16 ]
The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Change From Baseline in Weekly Mean Sleep Interference Score [ Time Frame: Baseline, Week 16 ]
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).
Change From Baseline in Weekly Mean Pain Score by Week [ Time Frame: Baseline, Week 1 through16 ]
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline [ Time Frame: Baseline, Week 16 ]
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score [ Time Frame: Baseline, Week 16 ]
The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia [ Time Frame: Baseline, Week 16 ]
Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia [ Time Frame: Baseline, Week 16 ]
Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia [ Time Frame: Baseline, Week 16 ]
Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli [ Time Frame: Baseline, Week 16 ]
Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia [ Time Frame: Baseline, Week 16 ]
Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales [ Time Frame: Baseline, Week 16 ]
Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4) [ Time Frame: Baseline, Week 16 ]
NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.
Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7) [ Time Frame: Baseline, Week 16 ]
NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS) [ Time Frame: Baseline, Week 16 ]
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety [ Time Frame: Baseline, Week 16 ]
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression [ Time Frame: Baseline, Week 16 ]
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

Other Outcome Measures:

Change From Baseline in Weekly Mean Sleep Interference Score by Week [ Time Frame: Baseline, Week 1 through 16 ]
Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
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:

Pregabalin use in the last 60 days, prior intolerance to pregabalin
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407745

Locations

Show 67 study locations

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United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
Pfizer Investigational Site
Phoenix, Arizona, United States, 85027
Pfizer Investigational Site
Phoenix, Arizona, United States, 85050
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93710
Pfizer Investigational Site
Napa, California, United States, 94558
Pfizer Investigational Site
Northridge, California, United States, 91324
Pfizer Investigational Site
Pasadena, California, United States, 91105
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33125
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
White Plains, New York, United States, 10605
United States, North Carolina
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Bellevue, Ohio, United States, 44811
United States, Pennsylvania
Pfizer Investigational Site
Johnstown, Pennsylvania, United States, 15904
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
United States, West Virginia
Pfizer Investigational Site
Charleston, West Virginia, United States, 25301
Pfizer Investigational Site
Charleston, West Virginia, United States, 25304
Chile
Pfizer Investigational Site
Vina del Mar, V Region, Chile, 2520024
China, Beijing
Pfizer Investigational Site
Beijing, Beijing, China, 100053
China, Sichuan
Pfizer Investigational Site
Chengdu, Sichuan, China, 610041
China
Pfizer Investigational Site
Beijing, China, 100068
Colombia
Pfizer Investigational Site
Medellín, Antioquia, Colombia
Czechia
Pfizer Investigational Site
Brno, Czechia, 66250
Pfizer Investigational Site
Liberec 1, Czechia, 46063
Pfizer Investigational Site
Praha 5, Czechia, 15006
Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong, 0
India
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, India, 500 003
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 034
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 052
Pfizer Investigational Site
Mangalore, Karnataka, India, 575002
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226 018
Pfizer Investigational Site
New Delhi, India, 110 070
Japan
Pfizer Investigational Site
Nagoya, Aichi, 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, Hyogo, 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, Japan
Pfizer Investigational Site
Hanyu, 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
Philippines
Pfizer Investigational Site
Espana, Manila, Philippines, 1008
Pfizer Investigational Site
Cebu City, Philippines
Pfizer Investigational Site
Manila, Philippines
Pfizer Investigational Site
Quezon City, Philippines, 1100
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 105203
Pfizer Investigational Site
St.Petersburg, Russian Federation, 197706

Sponsors and Collaborators

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:	NCT00407745
Other Study ID Numbers:	A0081107
First Posted:	December 5, 2006 Key Record Dates
Results First Posted:	December 8, 2011
Last Update Posted:	January 25, 2021
Last Verified:	February 2012

Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):


Pain central neuropathic pain

Additional relevant MeSH terms:

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Spinal Cord Injuries Neuralgia Wounds and Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Peripheral Nervous System Diseases Neuromuscular Diseases Pain Neurologic Manifestations Pregabalin Analgesics	Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs

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