Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component
NCT01838044
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- 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
- 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
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Descriptive Information | ||||
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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:
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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 |
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Study Arms ICMJE |
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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 | 180 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |