NeuralgiaPhase 3NCT00407745
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
A Phase 3 study testing pregabalin in people with Neuralgia and Spinal Cord Injuries, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 67 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Spinal Cord Injuries
- What is being tested?
- pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 67 sitesin 10 countries
- Study dates
- Jan 2007to Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
67 sites in 10 countries.
67 sites in 10 countries
Japan24 sites
Pfizer Investigational Site
Beppu, Oita Prefecture
Pfizer Investigational Site
Bibai, Hokkaido
Pfizer Investigational Site
Chiba
Pfizer Investigational Site
Daisen, Akita
Pfizer Investigational Site
Fukuyama, Hiroshima
Pfizer Investigational Site
Hakodate, Hokkaido
Pfizer Investigational Site
Hamamatsu, Shizuoka
Pfizer Investigational Site
Hanyū, Saitama
Pfizer Investigational Site
Higashiokitama-gun, Yamagata
Pfizer Investigational Site
Iizuka, Fukuoka
Pfizer Investigational Site
Kanuma, Tochigi
Pfizer Investigational Site
Kashiwazaki, Niigata
Pfizer Investigational Site
Kawasaki, Kanagawa
Pfizer Investigational Site
Kikuchi-gun, Kumamoto
Pfizer Investigational Site
Kitamoto, Saitama
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Kotoku, Tokyo
Pfizer Investigational Site
Musashimurayama-shi, Tokyo
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Sasima-gun, Ibaraki
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Tokushima
Pfizer Investigational Site
Yamagata
United States22 sites
Pfizer Investigational Site
Bellevue, Ohio, 44811
Pfizer Investigational Site
Charleston, West Virginia, 25301
Pfizer Investigational Site
Charleston, West Virginia, 25304
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904
Pfizer Investigational Site
Miami, Florida, 33125
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Napa, California, 94558
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
Northridge, California, 91324
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Phoenix, Arizona, 85027
Pfizer Investigational Site
Phoenix, Arizona, 85050
Pfizer Investigational Site
White Plains, New York, 10605
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
India6 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Bangalore, Karnataka, 560 052
Pfizer Investigational Site
Lucknow, Uttar Pradesh, 226 018
Pfizer Investigational Site
Mangalore, Karnataka, 575002
Pfizer Investigational Site
New Delhi, 110 070
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, 500 003
Philippines4 sites
Pfizer Investigational Site
Cebu City
Pfizer Investigational Site
España, Manila, 1008
Pfizer Investigational Site
Manila
Pfizer Investigational Site
Quezon City, 1100
China3 sites
Pfizer Investigational Site
Beijing, Beijing Municipality, 100053
Pfizer Investigational Site
Beijing, 100068
Pfizer Investigational Site
Chengdu, Sichuan, 610041
Czechia3 sites
Pfizer Investigational Site
Brno, 66250
Pfizer Investigational Site
Liberec, 46063
Pfizer Investigational Site
Prague, 15006
Russia2 sites
Pfizer Investigational Site
Moscow, 105203
Pfizer Investigational Site
Saint Petersburg, 197706
About this study
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
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.
- Conditions
- Neuralgia, Spinal Cord Injuries
- Being tested
- placebo, pregabalin
- Keywords
- Pain, central neuropathic pain
- Medical subject headings
- Neuralgia, Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Placebo
pregabalinDrug
Also called Lyrica
Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| matched placebo | Placebo comparator | Not described Receives: Drug: placebo |
| pregabalin | Experimental | flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period Receives: Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration Adjusted Average Change (DAAC) of Mean Pain Score
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.
Measured: Baseline, Week 16
Secondary outcomes (32)
Change From Baseline in Weekly Mean Pain Score
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).
Measured: Baseline, Week 16
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline
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).
Measured: Baseline, Week 16
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)
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.
Measured: Baseline, Week 16
Change From Baseline in Weekly Mean Sleep Interference Score
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]).
Measured: Baseline, Week 16
Change From Baseline in Weekly Mean Pain Score by Week
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).
Measured: Baseline, Week 1 through16
Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline
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).
Measured: Baseline, Week 16
Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score
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.
Measured: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia
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).
Measured: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia
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).
Measured: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia
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).
Measured: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli
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).
Measured: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia
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).
Measured: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales
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).
Measured: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score
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.
Measured: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain
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.
Measured: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain
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.
Measured: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
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.
Measured: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
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.
Measured: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia
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.
Measured: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score
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.
Measured: Baseline, Week 16
Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)
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.
Measured: Baseline, Week 16
Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)
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.
Measured: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index
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.
Measured: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance
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.
Measured: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy
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.
Measured: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring
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.
Measured: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache
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.
Measured: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity
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.
Measured: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence
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.
Measured: Baseline, Week 16
Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)
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.
Measured: Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety
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.
Measured: Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression
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.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407745
- Sponsor's protocol ID
- A0081107
- Status last verified
- Feb 2012
- First submitted
- 1 Dec 2006
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28072797Markman 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.
PubMed 27611736Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
PubMed 27448285Cardenas 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.
PubMed 23345639
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00407745
- Acronym / sponsor ID
- A0081107
- Conditions
- Neuralgia, Spinal Cord Injuries
- Keywords
- Pain, central neuropathic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Dec 2006 (estimated)
- Results
- Posted 8 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| matched placebo | Placebo comparator | Drug: placebo |
| pregabalin | Experimental | Drug: pregabalinflexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboPlacebo | Drug | matched placebo |
| pregabalinAlso: LyricaPregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day) | Drug | pregabalin |
Primary outcome
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.
32 secondary outcomes
Change From Baseline in Weekly Mean Pain Score
Time frame: Baseline, Week 16
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline
Time frame: Baseline, Week 16
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)
Time frame: Baseline, Week 16
Change From Baseline in Weekly Mean Sleep Interference Score
Time frame: Baseline, Week 16
Change From Baseline in Weekly Mean Pain Score by Week
Time frame: Baseline, Week 1 through16
Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline
Time frame: Baseline, Week 16
Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia
Time frame: Baseline, Week 16
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
Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)
Time frame: Baseline, Week 16
Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence
Time frame: Baseline, Week 16
Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)
Time frame: Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety
Time frame: Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28072797Schug 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.
- Derived from this study: PubMed 27611736Markman 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.
- Derived from this study: PubMed 27448285Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
- Derived from this study: PubMed 23345639Cardenas 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
67 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pregabalin in people with Neuralgia and Spinal Cord Injuries, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 67 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in Japan, United States, India, Philippines, China and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration Adjusted Average Change (DAAC) of Mean Pain Score (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407745, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.