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Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component

Primary Purpose

Chronic Low Back Pain With a Neuropathic Component

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
pregabalin and celecoxib
Placebo and celecoxib
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain With a Neuropathic Component

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have Chronic low back pain with high probability of a significant neuropathic component for 4 years or less (but no less than 3 months)
  • Subjects must be in generally good health, except for the presence of chronic low back pain with a neuropathic component.
  • Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone or the internet in order to complete the IVRS assessments each day, perform telephone or web visits and complete all required assessments/forms

Exclusion Criteria:

  • Subjects with past history of surgery for chronic low back pain.
  • Subjects with past history of failure on pregabalin treatment and/or intolerance associated with pregabalin or gabapentin.
  • Subjects with past history of intolerance associated with celecoxib or known hypersensitivity to celecoxib.
  • Patients with anticipated need for treatment with opioid analgesics, anti-epileptic medications, SNRI antidepressants or tricyclic antidepressants to alleviate pain during the course of the study.
  • Patients with chronic low back pain with a neuropathic component for more than 4 years.
  • Patients with neurologic disorders unrelated to low back pain that may confuse or confound the assessment of neuropathic pain (eg, primary or secondary nerve diseases).
  • Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
  • Use of prohibited medications in the absence of appropriate washout periods.
  • Patients with any severe pain associated with conditions other than chronic low back pain with a neuropathic component that may confound the assessment or self-evaluation of the pain due to chronic low back pain.
  • Patients with diabetes with poor glycemic control (HbA1c >8%).
  • Patients with any clinically significant or unstable medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, would compromise participation in the study
  • Patients who have participated in any previous clinical trial for pregabalin or have participated in 2 or more previous clinical trials for pain related to chronic low back pain.
  • Patients who are likely to require surgery during the course of the study (except minor surgery, eg, for skin conditions)
  • Patients with a history of Substance Abuse as defined by DSM-IV-TR diagnostic criteria

Sites / Locations

  • Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC
  • Santa Casa de Misericórdia de Belo Horizonte
  • CMIP-Centro Mineiro de Pesquisa
  • EDUMED Educação em Saúde - Centro de Pesquisas Clínicas
  • Instituto Paulista de Reumatologia da UNIFESP
  • Faculdade de Medicina do ABC
  • Instituto Paulista de Reumatologia da UNIFESP
  • Instituto de Pesquisa Clinica e Medicina Avancada - IMA Brasil
  • Centro de Diagnostico y Tratamiento Ltd. Clinica Siresa
  • Centro de Investigación Clínica Neuropsicología Ltda
  • Fundacion Cardiovascular de Colombia - Instituto del Corazon Floridablanca
  • Centro Medico Imbanaco C.M.I (Sede 01 and Sede 02) / Sede 12 Centro Medico Imbanaco de Cali S.A.
  • Hospital Raja Permaisuri Bainun
  • Hospital Seberang Jaya
  • Hospital Umum Sarawak (Sarawak General Hospital)
  • Hospital Selayang
  • MENTRIALS S. A. de C. V.
  • Centro Integral en Reumatología SA de CV
  • Clinica De Investigacion En Reumatologia Y Obesidad S.C.
  • Centro de Estudios de Investigacion Basica y Clinica SC.
  • Hospital Angeles Chapalita
  • Unidad de Cancerología
  • Accelerium S. de R.L de C.V.
  • Unidad de Atención Médica e Investigacion en salud
  • Unidad de Atencion Medica e Investigación en salud SC
  • Centro de Investigacion y Atencion Integral de Durango SC
  • Raffles Hospital
  • Maharaj Nakorn ChiangMai Hospital
  • Sappasithiprasong Hospital
  • Division of Neurology ,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm A

Arm B

Arm Description

The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.

The group of patients who are randomized to receive celecoxib monotherapy during the first study period.

Outcomes

Primary Outcome Measures

Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.

Secondary Outcome Measures

Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.
Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)
The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 ("pain does not interfere with sleep") to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents 'does not interfere with sleep' and 10 represents 'completely interferes' which means you are unable to sleep due to pain.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.
Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2
Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its 'worst,' 'least,' 'average,' and 'now' (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10
The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.
Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.

Full Information

First Posted
April 15, 2013
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01838044
Brief Title
Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component
Official Title
A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Concomitant Administration Of Celecoxib And Pregabalin Compared With Celecoxib Monotherapy, In Patients With Chronic Low Back Pain Having A Neuropathic Component
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment terminated on 3Apr2015 due to slow recruitment rate and lack of operational feasibility. Study was not terminated for reasons of safety/efficacy.
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if treatment with celecoxib and pregabalin together would prove to be more effective in relief of pain than treatment with celecoxib alone in people who have chronic low back pain with a probable neuropathic component.
Detailed Description
The primary objective is to evaluate the efficacy of the concomitant use of pregabalin and celecoxib compared with celecoxib monotherapy for the symptomatic relief of pain in patients with chronic low back pain with a probable neuropathic component. The secondary objectives are: Demonstrate the additional benefit of adding pregabalin to celecoxib monotherapy. To evaluate the concomitant use of pregabalin and celecoxib compared to celecoxib monotherapy in a set of patient reported measures (sleep, depression, anxiety, impact of pain in daily functions, patient's global impression of change and patient's perception of the treatment). To evaluate the safety and tolerability of celecoxib and of the concomitant administration of pregabalin and celecoxib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain With a Neuropathic Component

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.
Arm Title
Arm B
Arm Type
Other
Arm Description
The group of patients who are randomized to receive celecoxib monotherapy during the first study period.
Intervention Type
Drug
Intervention Name(s)
pregabalin and celecoxib
Intervention Description
During the first study period subjects in Arm A will be administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg BID) for one week (during Week 0) followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks. During the second study period all subjects will be administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Subjects in Arm B will be initiated on pregabalin 150 mg (75 mg BID) daily for one week, before pregabalin will up titrated to 300 mg (150 mg BID) daily. All subjects will complete a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose will be decreased to 150 mg (75 mg BID) daily and subjects will participate in a follow up visit for a final safety assessment.
Intervention Type
Drug
Intervention Name(s)
Placebo and celecoxib
Intervention Description
Subjects in Arm B will be administered a daily fixed dose celecoxib 200 mg and placebo of pregabalin for 5 weeks. During the second study period all subjects will be administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Subjects in Arm B will be initiated on pregabalin 150 mg (75 mg BID) daily for one week, before pregabalin will up titrated to 300 mg (150 mg BID) daily. All subjects will complete a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose will be decreased to 150 mg (75 mg BID) daily and subjects will participate in a follow up visit for a final safety assessment.
Primary Outcome Measure Information:
Title
Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms
Description
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame
Baseline and Week 5
Secondary Outcome Measure Information:
Title
Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).
Description
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame
Week 5 and Week 10
Title
Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms
Description
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame
Baseline and Week 10
Title
Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
Description
The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.
Time Frame
Week 5 and Week 10
Title
Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
Description
The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
Time Frame
Week 5 and Week 10
Title
Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)
Description
The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
Time Frame
Week 5 and Week 10
Title
Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
Description
The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 ("pain does not interfere with sleep") to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents 'does not interfere with sleep' and 10 represents 'completely interferes' which means you are unable to sleep due to pain.
Time Frame
Week 5 and Week 10
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
Description
The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.
Time Frame
Week 5 and Week 10
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
Description
The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.
Time Frame
Week 5 and Week 10
Title
Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2
Description
Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Time Frame
Period 1 and Period 2
Title
Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10
Description
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its 'worst,' 'least,' 'average,' and 'now' (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.
Time Frame
Week 5 and Week 10
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10
Description
The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.
Time Frame
Week 5 and Week 10
Title
Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
Description
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame
Week 5 and Week 10
Title
Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
Description
The Daily Pain diary consists of an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame
Week 5 and Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have Chronic low back pain with high probability of a significant neuropathic component for 4 years or less (but no less than 3 months) Subjects must be in generally good health, except for the presence of chronic low back pain with a neuropathic component. Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone or the internet in order to complete the IVRS assessments each day, perform telephone or web visits and complete all required assessments/forms Exclusion Criteria: Subjects with past history of surgery for chronic low back pain. Subjects with past history of failure on pregabalin treatment and/or intolerance associated with pregabalin or gabapentin. Subjects with past history of intolerance associated with celecoxib or known hypersensitivity to celecoxib. Patients with anticipated need for treatment with opioid analgesics, anti-epileptic medications, SNRI antidepressants or tricyclic antidepressants to alleviate pain during the course of the study. Patients with chronic low back pain with a neuropathic component for more than 4 years. Patients with neurologic disorders unrelated to low back pain that may confuse or confound the assessment of neuropathic pain (eg, primary or secondary nerve diseases). Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment. Use of prohibited medications in the absence of appropriate washout periods. Patients with any severe pain associated with conditions other than chronic low back pain with a neuropathic component that may confound the assessment or self-evaluation of the pain due to chronic low back pain. Patients with diabetes with poor glycemic control (HbA1c >8%). Patients with any clinically significant or unstable medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, would compromise participation in the study Patients who have participated in any previous clinical trial for pregabalin or have participated in 2 or more previous clinical trials for pain related to chronic low back pain. Patients who are likely to require surgery during the course of the study (except minor surgery, eg, for skin conditions) Patients with a history of Substance Abuse as defined by DSM-IV-TR diagnostic criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC
City
São Luís
State/Province
Maranhão
ZIP/Postal Code
65020-600
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
CMIP-Centro Mineiro de Pesquisa
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
EDUMED Educação em Saúde - Centro de Pesquisas Clínicas
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
Instituto Paulista de Reumatologia da UNIFESP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04026-000
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
SÃO Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Instituto Paulista de Reumatologia da UNIFESP
City
Sao Paulo
State/Province
SÃO Paulo
ZIP/Postal Code
04026-000
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica e Medicina Avancada - IMA Brasil
City
Sao Paulo
ZIP/Postal Code
05437-010
Country
Brazil
Facility Name
Centro de Diagnostico y Tratamiento Ltd. Clinica Siresa
City
Temuco
State/Province
Araucania
Country
Chile
Facility Name
Centro de Investigación Clínica Neuropsicología Ltda
City
La Florida
State/Province
Santiago
Country
Chile
Facility Name
Fundacion Cardiovascular de Colombia - Instituto del Corazon Floridablanca
City
Floridablanca
State/Province
Santander
Country
Colombia
Facility Name
Centro Medico Imbanaco C.M.I (Sede 01 and Sede 02) / Sede 12 Centro Medico Imbanaco de Cali S.A.
City
Santiago de Cali
Country
Colombia
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Seberang Jaya
City
Seberang Jaya
State/Province
Pulau Pinang
ZIP/Postal Code
13700
Country
Malaysia
Facility Name
Hospital Umum Sarawak (Sarawak General Hospital)
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Selayang
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
MENTRIALS S. A. de C. V.
City
Mexico
State/Province
DF
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Centro Integral en Reumatología SA de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Clinica De Investigacion En Reumatologia Y Obesidad S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Basica y Clinica SC.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Hospital Angeles Chapalita
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Unidad de Cancerología
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45050
Country
Mexico
Facility Name
Accelerium S. de R.L de C.V.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Unidad de Atención Médica e Investigacion en salud
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigación en salud SC
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Centro de Investigacion y Atencion Integral de Durango SC
City
Durango
ZIP/Postal Code
34080
Country
Mexico
Facility Name
Raffles Hospital
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
Maharaj Nakorn ChiangMai Hospital
City
Muang
State/Province
Chiang MAI
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Sappasithiprasong Hospital
City
Muang
State/Province
Ubonratchathani Thailand
ZIP/Postal Code
34000
Country
Thailand
Facility Name
Division of Neurology ,
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081296&StudyName=Efficacy%20and%20Safety%20Study%20of%20Celecoxib%20and%20Pregabalin%20Compared%20with%20Celecoxib%20Monotherapy%2C%20in%20Patients%20with%20Chronic%20Low%20Back%20Pain%20Havi
Description
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Learn more about this trial

Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component

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