Clinical trial NCT01838044: 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: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Low Back Pain With a Neuropathic Component
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-04-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 5
Secondary outcomes:
measure: Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).
timeFrame: Week 5 and Week 10
measure: Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms
timeFrame: Baseline and Week 10
measure: 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)
timeFrame: Week 5 and Week 10
measure: Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
timeFrame: Week 5 and Week 10
measure: Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)
timeFrame: Week 5 and Week 10
measure: Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
timeFrame: Week 5 and Week 10
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
timeFrame: Week 5 and Week 10
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
timeFrame: Week 5 and Week 10
measure: Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2
timeFrame: Period 1 and Period 2
measure: Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10
timeFrame: Week 5 and Week 10
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10
timeFrame: Week 5 and Week 10
measure: Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
timeFrame: Week 5 and Week 10
measure: Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
timeFrame: Week 5 and Week 10
Other outcomes:
Locations:
city: São Luís
country: Brazil
facility: Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC
state: Maranhão
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: CMIP-Centro Mineiro de Pesquisa
state: Minas Gerais
city: Curitiba
country: Brazil
facility: EDUMED Educação em Saúde - Centro de Pesquisas Clínicas
state: Paraná
city: São Paulo
country: Brazil
facility: Instituto Paulista de Reumatologia da UNIFESP
state: SP
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: SÃO Paulo
city: Sao Paulo
country: Brazil
facility: Instituto Paulista de Reumatologia da UNIFESP
state: SÃO Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Pesquisa Clinica e Medicina Avancada - IMA Brasil
city: Temuco
country: Chile
facility: Centro de Diagnostico y Tratamiento Ltd. Clinica Siresa
state: Araucania
city: La Florida
country: Chile
facility: Centro de Investigación Clínica Neuropsicología Ltda
state: Santiago
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia - Instituto del Corazon Floridablanca
state: Santander
city: Santiago de Cali
country: Colombia
facility: Centro Medico Imbanaco C.M.I (Sede 01 and Sede 02) / Sede 12 Centro Medico Imbanaco de Cali S.A.
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Seberang Jaya
country: Malaysia
facility: Hospital Seberang Jaya
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak (Sarawak General Hospital)
state: Sarawak
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
state: Selangor
city: Mexico
country: Mexico
facility: MENTRIALS S. A. de C. V.
state: DF
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatología SA de CV
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica De Investigacion En Reumatologia Y Obesidad S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica SC.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital Angeles Chapalita
state: Jalisco
city: Zapopan
country: Mexico
facility: Unidad de Cancerología
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L de C.V.
state: Nuevo LEON
city: Merida
country: Mexico
facility: Unidad de Atención Médica e Investigacion en salud
state: Yucatan
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigación en salud SC
state: Yucatán
city: Durango
country: Mexico
facility: Centro de Investigacion y Atencion Integral de Durango SC
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Muang
country: Thailand
facility: Maharaj Nakorn ChiangMai Hospital
state: Chiang MAI
city: Muang
country: Thailand
facility: Sappasithiprasong Hospital
state: Ubonratchathani Thailand
city: Bangkok
country: Thailand
facility: Division of Neurology ,
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: