You are here

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 February 18, 2019

FOR MORE INFORMATION
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now