Suspended

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

What is being tested

pregabalin and celecoxib

+ Placebo and celecoxib

Drug

Who is being recruted

From 18 to 75 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: October 2013

See protocol details

Summary

Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Last updated: January 28, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01838044

Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Last updated: January 28, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

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 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)

14 exclusion criteria prevent from participating

Patients who are likely to require surgery during the course of the study (except minor surgery, eg, for skin conditions)

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 with a history of Substance Abuse as defined by DSM-IV-TR diagnostic criteria

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 29 locations

Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC

São Luís, BrazilOpen Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC in Google Maps

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Brazil

CMIP-Centro Mineiro de Pesquisa

Juiz de Fora, Brazil

EDUMED Educação em Saúde - Centro de Pesquisas Clínicas

Curitiba, Brazil

Suspended29 Study Centers