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

Phase 4

Terminated

Conditions: Chronic Low Back Pain With a Neuropathic Component

Interventions: Drug: pregabalin and celecoxib
Drug: Placebo and celecoxib

Registration Number: NCT01838044

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 180

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	pregabalin and celecoxib	The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.
Arm B	Placebo and celecoxib	The group of patients who are randomized to receive celecoxib monotherapy during the first study period.

Primary Outcome Measures

Name	Time	Method
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	Baseline and Week 5	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.
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	The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
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	The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
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)	Week 5 and Week 10	The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 ("pain does not interfere with sleep") to 10 ("pain completely interferes with sleep" \[unable to sleep due to pain\]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents 'does not interfere with sleep' and 10 represents 'completely interferes' which means you are unable to sleep due to pain.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)	Week 5 and Week 10	The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)	Week 5 and Week 10	The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.
Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2	Period 1 and Period 2	Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10	Week 5 and Week 10	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its 'worst,' 'least,' 'average,' and 'now' (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10	Week 5 and Week 10	The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.
Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10	Week 5 and Week 10	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.
Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10	Week 5 and Week 10	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.

Trial Locations

Locations (29): Centro Integral en Reumatología SA de CV
🇲🇽
Guadalajara, Jalisco, Mexico
Raffles Hospital
🇸🇬
Singapore, Singapore
Centro de Investigación Clínica Neuropsicología Ltda
🇨🇱
La Florida, Santiago, Chile
Instituto Paulista de Reumatologia da UNIFESP
🇧🇷
Sao Paulo, SÃO Paulo, Brazil
Santa Casa de Misericórdia de Belo Horizonte
🇧🇷
Belo Horizonte, Minas Gerais, Brazil
Unidad de Atencion Medica e Investigación en salud SC
🇲🇽
Merida, Yucatán, Mexico
CMIP-Centro Mineiro de Pesquisa
🇧🇷
Juiz de Fora, Minas Gerais, Brazil
Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC
🇧🇷
São Luís, Maranhão, Brazil
EDUMED Educação em Saúde - Centro de Pesquisas Clínicas
🇧🇷
Curitiba, Paraná, Brazil
Centro Medico Imbanaco C.M.I (Sede 01 and Sede 02) / Sede 12 Centro Medico Imbanaco de Cali S.A.
🇨🇴
Santiago de Cali, Colombia
Instituto de Pesquisa Clinica e Medicina Avancada - IMA Brasil
🇧🇷
Sao Paulo, Brazil
Faculdade de Medicina do ABC
🇧🇷
Santo André, SÃO Paulo, Brazil
Centro de Diagnostico y Tratamiento Ltd. Clinica Siresa
🇨🇱
Temuco, Araucania, Chile
Fundacion Cardiovascular de Colombia - Instituto del Corazon Floridablanca
🇨🇴
Floridablanca, Santander, Colombia
Hospital Raja Permaisuri Bainun
🇲🇾
Ipoh, Perak, Malaysia
Hospital Seberang Jaya
🇲🇾
Seberang Jaya, Pulau Pinang, Malaysia
MENTRIALS S. A. de C. V.
🇲🇽
Mexico, DF, Mexico
Hospital Selayang
🇲🇾
Batu Caves, Selangor, Malaysia
Hospital Umum Sarawak (Sarawak General Hospital)
🇲🇾
Kuching, Sarawak, Malaysia
Clinica De Investigacion En Reumatologia Y Obesidad S.C.
🇲🇽
Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Basica y Clinica SC.
🇲🇽
Guadalajara, Jalisco, Mexico
Unidad de Cancerología
🇲🇽
Zapopan, Jalisco, Mexico
Unidad de Atención Médica e Investigacion en salud
🇲🇽
Merida, Yucatan, Mexico
Hospital Angeles Chapalita
🇲🇽
Guadalajara, Jalisco, Mexico
Division of Neurology ,
🇹🇭
Bangkok, Thailand
Accelerium S. de R.L de C.V.
🇲🇽
Monterrey, Nuevo LEON, Mexico
Centro de Investigacion y Atencion Integral de Durango SC
🇲🇽
Durango, Mexico
Maharaj Nakorn ChiangMai Hospital
🇹🇭
Muang, Chiang MAI, Thailand
Sappasithiprasong Hospital
🇹🇭
Muang, Ubonratchathani Thailand, Thailand