Chronic Low Back Pain With a Neuropathic ComponentPhase 4NCT01838044
Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component
A Phase 4 study testing pregabalin and celecoxib in people with Chronic Low Back Pain With a Neuropathic Component, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 29 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain With a Neuropathic Component
- What is being tested?
- pregabalin and celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 29 sitesin 7 countries
- Study dates
- Oct 2013to Jun 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 14Show fewer
- 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
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Mexico10 sites
Centro de Investigacion y Atencion Integral de Durango SC
Durango, 34080
Centro Integral en Reumatología SA de CV
Guadalajara, Jalisco, 44160
Clinica De Investigacion En Reumatologia Y Obesidad S.C.
Guadalajara, Jalisco, 44650
Centro de Estudios de Investigacion Basica y Clinica SC.
Guadalajara, Jalisco, 44690
Hospital Angeles Chapalita
Guadalajara, Jalisco, 45040
Unidad de Atención Médica e Investigacion en salud
Mérida, Yucatán, 97000
Unidad de Atencion Medica e Investigación en salud SC
Mérida, Yucatán, 97130
MENTRIALS S. A. de C. V.
Mexico City, Mexico City, 06700
Accelerium S. de R.L de C.V.
Monterrey, Nuevo León, 64000
Unidad de Cancerología
Zapopan, Jalisco, 45050
Brazil7 sites
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221
EDUMED Educação em Saúde - Centro de Pesquisas Clínicas
Curitiba, Paraná, 80440-080
CMIP-Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC
São Luís, Maranhão, 65020-600
Instituto Paulista de Reumatologia da UNIFESP
São Paulo, São Paulo, 04026-000
Instituto de Pesquisa Clinica e Medicina Avancada - IMA Brasil
São Paulo, 05437-010
Malaysia4 sites
Hospital Selayang
Batu Caves, Selangor, 68100
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990
Hospital Umum Sarawak (Sarawak General Hospital)
Kuching, Sarawak, 93586
Hospital Seberang Jaya
Seberang Jaya, Pulau Pinang, 13700
Thailand3 sites
Division of Neurology ,
Bangkok, 10400
Maharaj Nakorn ChiangMai Hospital
Muang, Chiang Mai, 50200
Sappasithiprasong Hospital
Muang, Ubonratchathani Thailand, 34000
Chile2 sites
Centro de Investigación Clínica Neuropsicología Ltda
La Florida, Santiago Metropolitan
Centro de Diagnostico y Tratamiento Ltd. Clinica Siresa
Temuco, Araucania
Colombia2 sites
Fundacion Cardiovascular de Colombia - Instituto del Corazon Floridablanca
Floridablanca, Santander Department
Centro Medico Imbanaco C.M.I (Sede 01 and Sede 02) / Sede 12 Centro Medico Imbanaco de Cali S.A.
Santiago de Cali
About this study
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
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.
Read the 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.
- Being tested
- pregabalin and celecoxib, Placebo and celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin and celecoxibDrug
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.
Placebo and celecoxibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period. Receives: Drug: pregabalin and celecoxib |
| Arm B | Other | The group of patients who are randomized to receive celecoxib monotherapy during the first study period. Receives: Drug: Placebo and celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Week 5 and Week 10
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)
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.
Measured: Week 5 and Week 10
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
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.
Measured: Week 5 and Week 10
Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
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.
Measured: Week 5 and Week 10
Percentage of Days in Mild, Moderate and Severe Pain at 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.
Measured: Period 1 and Period 2
Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at 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.
Measured: Week 5 and Week 10
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at 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.
Measured: Week 5 and Week 10
Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at 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.
Measured: Week 5 and Week 10
Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at 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.
Measured: Week 5 and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionJun 2015
Why it stopped: Recruitment terminated on 3Apr2015 due to slow recruitment rate and lack of operational feasibility. Study was not terminated for reasons of safety/efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back Pain With a Neuropathic ComponentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838044
- Sponsor's protocol ID
- A0081296
- Status last verified
- Jul 2016
- First submitted
- 15 Apr 2013
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01838044
- Acronym / sponsor ID
- A0081296
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment terminated on 3Apr2015 due to slow recruitment rate and lack of operational feasibility. Study was not terminated for reasons of safety/efficacy.
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Posted 1 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: pregabalin and celecoxibThe group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period. |
| Arm B | Other | Drug: Placebo and celecoxibThe group of patients who are randomized to receive celecoxib monotherapy during the first study period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregabalin and celecoxibDuring 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. | Drug | Arm A |
| Placebo and celecoxibSubjects 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. | Drug | Arm B |
Primary outcome
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
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.
13 secondary outcomes
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
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
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
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
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
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
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
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
Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2
Time frame: Period 1 and Period 2
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pregabalin and celecoxib in people with Chronic Low Back Pain With a Neuropathic Component, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 29 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Mexico, Brazil, Malaysia, Thailand, Chile and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline and Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.