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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

Last updated on December 12, 2019

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Study Location
Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC
São Luís, Maranhão, 65020-600 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Low Back Pain With a Neuropathic Component
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01838044
Pfizer
Terminated
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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Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain With a Neuropathic Component
Intervention  ICMJE
  • Drug: pregabalin and celecoxib

    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.

  • Drug: Placebo and celecoxib

    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.

Study Arms  ICMJE
  • Experimental: Arm A
    The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.
    Intervention: Drug: pregabalin and celecoxib
  • Arm B
    The group of patients who are randomized to receive celecoxib monotherapy during the first study period.
    Intervention: Drug: Placebo and celecoxib
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 23, 2015)
180
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2013)
366
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Chile,   Colombia,   Malaysia,   Mexico,   Singapore,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01838044
Other Study ID Numbers  ICMJE A0081296
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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