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

NCT01838044 | Terminated Phase 4 Results DMC

• 1 other identifier: A0081296
• Study Type: interventional
• Target: 180
• Locations: 7 countries
• Sites: 29

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.

Conditions

Chronic Low Back Pain With a Neuropathic Component

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 5

Secondary Outcomes (13)

• Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).

  Week 5 and Week 10

• Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms

  Baseline and Week 10

• 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)

  Week 5 and Week 10

• Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)

  Week 5 and Week 10

• Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)

  Week 5 and Week 10

Study Arms (2)

Arm A

EXPERIMENTAL

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

Drug: pregabalin and celecoxib

Arm B

OTHER

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

Drug: Placebo and celecoxib

Interventions

pregabalin and celecoxib DRUG

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.

Arm A

Placebo and celecoxib DRUG

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.

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (29)

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

São Luís, Maranhão, 65020-600, Brazil

Location

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

CMIP-Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

EDUMED Educação em Saúde - Centro de Pesquisas Clínicas

Curitiba, Paraná, 80440-080, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

Instituto Paulista de Reumatologia da UNIFESP

São Paulo, São Paulo, 04026-000, Brazil

Location

Instituto de Pesquisa Clinica e Medicina Avancada - IMA Brasil

São Paulo, 05437-010, Brazil

Location

Centro de Diagnostico y Tratamiento Ltd. Clinica Siresa

Temuco, Región de la Araucanía, Chile

Location

Centro de Investigación Clínica Neuropsicología Ltda

La Florida, Santiago Metropolitan, Chile

Location

Fundacion Cardiovascular de Colombia - Instituto del Corazon Floridablanca

Floridablanca, Santander Department, Colombia

Location

Centro Medico Imbanaco C.M.I (Sede 01 and Sede 02) / Sede 12 Centro Medico Imbanaco de Cali S.A.

Santiago de Cali, Colombia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30990, Malaysia

Location

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

Hospital Umum Sarawak (Sarawak General Hospital)

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, 68100, Malaysia

Location

Centro Integral en Reumatología SA de CV

Guadalajara, Jalisco, 44160, Mexico

Location

Clinica De Investigacion En Reumatologia Y Obesidad S.C.

Guadalajara, Jalisco, 44650, Mexico

Location

Centro de Estudios de Investigacion Basica y Clinica SC.

Guadalajara, Jalisco, 44690, Mexico

Location

Hospital Angeles Chapalita

Guadalajara, Jalisco, 45040, Mexico

Location

Unidad de Cancerología

Zapopan, Jalisco, 45050, Mexico

Location

MENTRIALS S. A. de C. V.

Mexico City, Mexico City, 06700, Mexico

Location

Accelerium S. de R.L de C.V.

Monterrey, Nuevo León, 64000, Mexico

Location

Unidad de Atención Médica e Investigacion en salud

Mérida, Yucatán, 97000, Mexico

Location

Unidad de Atencion Medica e Investigación en salud SC

Mérida, Yucatán, 97130, Mexico

Location

Centro de Investigacion y Atencion Integral de Durango SC

Durango, 34080, Mexico

Location

Raffles Hospital

Singapore, 188770, Singapore

Location

Maharaj Nakorn ChiangMai Hospital

Muang, Chiang Mai, 50200, Thailand

Location

Sappasithiprasong Hospital

Muang, Ubonratchathani Thailand, 34000, Thailand

Location

Division of Neurology ,

Bangkok, 10400, Thailand

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Pregabalin; Celecoxib

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated as it had been determined that it was no longer operationally feasible to continue the trial. The study termination was not due to a safety issue or finding.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 23, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 28, 2021
• Results First Posted: September 1, 2016

Record last verified: 2016-07

Locations

CL (2); MY (4); SG (1); ME (10); TH (3); BR (7); CO (2)