- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 05437-010
- Instituto de Pesquisa Clinica e Medicina Avancada - IMA Brasil
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Maranhão
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São Luís, Maranhão, Brazil, 65020-600
- Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Juiz de Fora, Minas Gerais, Brazil, 36010-570
- Cmip-Centro Mineiro de Pesquisa
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Paraná
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Curitiba, Paraná, Brazil, 80440-080
- EDUMED Educação em Saúde - Centro de Pesquisas Clínicas
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SP
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São Paulo, SP, Brazil, 04026-000
- Instituto Paulista de Reumatologia da UNIFESP
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SÃO Paulo
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Santo André, SÃO Paulo, Brazil, 09060-650
- Faculdade de Medicina do ABC
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Sao Paulo, SÃO Paulo, Brazil, 04026-000
- Instituto Paulista de Reumatologia da UNIFESP
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Araucania
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Temuco, Araucania, Chile
- Centro de Diagnostico y Tratamiento Ltd. Clinica Siresa
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Santiago
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La Florida, Santiago, Chile
- Centro de Investigación Clínica Neuropsicología Ltda
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Santiago de Cali, Colombia
- Centro Medico Imbanaco C.M.I (Sede 01 and Sede 02) / Sede 12 Centro Medico Imbanaco de Cali S.A.
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Santander
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Floridablanca, Santander, Colombia
- Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
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Perak
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Ipoh, Perak, Malaysia, 30990
- Hospital Raja Permaisuri Bainun
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Pulau Pinang
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Seberang Jaya, Pulau Pinang, Malaysia, 13700
- Hospital Seberang Jaya
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Sarawak
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Kuching, Sarawak, Malaysia, 93586
- Hospital Umum Sarawak (Sarawak General Hospital)
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Selangor
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Batu Caves, Selangor, Malaysia, 68100
- Hospital Selayang
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Durango, Mexico, 34080
- Centro de Investigacion y Atencion Integral de Durango SC
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DF
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Mexico, DF, Mexico, 06700
- MENTRIALS S. A. de C. V.
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Jalisco
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Guadalajara, Jalisco, Mexico, 44690
- Centro de Estudios de Investigacion Basica y Clinica SC.
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Guadalajara, Jalisco, Mexico, 44160
- Centro Integral en Reumatologia SA de CV
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Guadalajara, Jalisco, Mexico, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S.C.
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Guadalajara, Jalisco, Mexico, 45040
- Hospital Angeles Chapalita
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Zapopan, Jalisco, Mexico, 45050
- Unidad de Cancerologia
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Nuevo LEON
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Monterrey, Nuevo LEON, Mexico, 64000
- Accelerium S. de R.L de C.V.
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Yucatan
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Merida, Yucatan, Mexico, 97000
- Unidad de Atencion Medica e Investigacion en Salud
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Yucatán
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Merida, Yucatán, Mexico, 97130
- Unidad de Atencion Medica e Investigación en salud SC
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Singapore, Singapore, 188770
- Raffles Hospital
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Bangkok, Thailand, 10400
- Division of Neurology ,
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Chiang MAI
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Muang, Chiang MAI, Thailand, 50200
- Maharaj Nakorn Chiangmai Hospital
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Ubonratchathani Thailand
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Muang, Ubonratchathani Thailand, Thailand, 34000
- Sappasithiprasong Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A
The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.
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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. |
Other: Arm B
The group of patients who are randomized to receive celecoxib monotherapy during the first study period.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
Time Frame: Baseline and Week 5
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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.
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Baseline and Week 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms
Time Frame: Baseline and Week 10
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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.
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Baseline and Week 10
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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)
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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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)
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2
Time Frame: Period 1 and Period 2
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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.
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Period 1 and Period 2
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Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
Time Frame: Week 5 and Week 10
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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.
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Week 5 and Week 10
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Cyclooxygenase 2 Inhibitors
- Calcium Channel Blockers
- Celecoxib
- Pregabalin
Other Study ID Numbers
- A0081296
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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