Chronic Low Back Pain With a Neuropathic Component
Conditions
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.
Interventions
DRUGpregabalin and celecoxib
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.
DRUGPlacebo and celecoxib
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.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
Brazil, Chile, Colombia, Malaysia, Mexico, Singapore, Thailand
Participant flow
Recruitment details
This study was conducted at 28 sites across 7 countries. From a total of 232 participants screened, 180 were randomized into Period 1 and 166 entered into Period 2.
Pre-assignment details
Participants who completed a minimum of 4 days per week of daily diaries during the 7 days preceding the baseline visit and had a mean weekly pain score \>= 4 at the end of screening were randomized to either Arm A or Arm B.
Participants by arm
| Arm | Count |
|---|---|
| Arm A During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily \[BID\]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment. | 89 |
| Arm B During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up-titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment. | 91 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 6 |
| Overall Study | Insufficient clinical response | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Medication error without associated AE | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Arm A | Arm B | Total |
|---|---|---|---|
| Age, Continuous | 49.7 Years STANDARD_DEVIATION 11.7 | 49.2 Years STANDARD_DEVIATION 12.2 | 49.5 Years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 65 Participants | 63 Participants | 128 Participants |
| Sex: Female, Male Male | 24 Participants | 28 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 89 | 19 / 91 |
| serious Total, serious adverse events | 0 / 89 | 2 / 91 |
Outcome results
Primary
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.
Time frame: Baseline and Week 5
Population: The Full Analysis Set (FAS) that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | 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 | -2.18 Units on a scale | Standard Error 0.212 |
| Arm B | 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 | -2.03 Units on a scale | Standard Error 0.212 |
Comparison: Statistical analysis at Week 5 compared between two study arms.p-value: 0.601295% CI: [-0.72, 0.42]Mixed Models Analysis
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | 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) | Benefit from Treatment - No benefit (Week 10) | 4.5 Percentage of participants |
| Arm A | 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) | Very Dissatisfied (Week 5) | 3.4 Percentage of participants |
| Arm A | 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) | Benefit from Treatment - Little benefit (Week 10) | 14.6 Percentage of participants |
| Arm A | 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) | Benefit from Treatment - Little benefit (Week 5) | 22.5 Percentage of participants |
| Arm A | 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) | Benefit from Treatment - Much benefit (Week 10) | 71.9 Percentage of participants |
| Arm A | 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) | Willingness to Continue - DVN (Week 5) - Yes | 94.4 Percentage of participants |
| Arm A | 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) | Satisfaction from Treatment - DVN (Week 10) - Yes | 83.1 Percentage of participants |
| Arm A | 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) | A Little Satisfied (Week 5) | 20.2 Percentage of participants |
| Arm A | 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) | Satisfaction from Treatment - DVN (Week 10) - No | 7.9 Percentage of participants |
| Arm A | 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) | Willingness to Continue - DVN (Week 5) - No | 0 Percentage of participants |
| Arm A | 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) | A Little Satisfied (Week 10) | 9.0 Percentage of participants |
| Arm A | 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) | Satisfaction from Treatment - DVN (Week 5) - Yes | 78.7 Percentage of participants |
| Arm A | 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) | Very Satisfied (Week 10) | 74.2 Percentage of participants |
| Arm A | 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) | A Little Bit Willing (Week 5) | 5.6 Percentage of participants |
| Arm A | 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) | A Little Dissatisfied (Week 10) | 5.6 Percentage of participants |
| Arm A | 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) | Very Satisfied (Week 5) | 58.4 Percentage of participants |
| Arm A | 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) | Very Dissatisfied (Week 10) | 2.2 Percentage of participants |
| Arm A | 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) | Very Willing (Week 5) | 88.8 Percentage of participants |
| Arm A | 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) | Willingness to Continue - DVN (Week 10) - Yes | 88.8 Percentage of participants |
| Arm A | 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) | Benefit from Treatment - Much benefit (Week 5) | 61.8 Percentage of participants |
| Arm A | 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) | Willingness to Continue - DVN (Week 10) - No | 2.2 Percentage of participants |
| Arm A | 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) | A Little Unwilling (Week 5) | 0 Percentage of participants |
| Arm A | 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) | A Little Bit Willing (Week 10) | 4.5 Percentage of participants |
| Arm A | 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) | A Little Dissatisfied (Week 5) | 12.4 Percentage of participants |
| Arm A | 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) | Very Willing (Week 10) | 84.3 Percentage of participants |
| Arm A | 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) | Very Unwilling (Week 5) | 0 Percentage of participants |
| Arm A | 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) | A Little Unwilling (Week 10) | 0 Percentage of participants |
| Arm A | 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) | Satisfaction from Treatment - DVN (Week 5) - No | 15.7 Percentage of participants |
| Arm A | 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) | Very Unwilling (Week 10) | 2.2 Percentage of participants |
| Arm A | 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) | Benefit from Treatment - No benefit (Week 5) | 10.1 Percentage of participants |
| Arm B | 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) | Very Unwilling (Week 10) | 2.2 Percentage of participants |
| Arm B | 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) | Benefit from Treatment - No benefit (Week 5) | 6.6 Percentage of participants |
| Arm B | 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) | Benefit from Treatment - Little benefit (Week 5) | 29.7 Percentage of participants |
| Arm B | 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) | Benefit from Treatment - Much benefit (Week 5) | 53.8 Percentage of participants |
| Arm B | 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) | Satisfaction from Treatment - DVN (Week 5) - Yes | 84.6 Percentage of participants |
| Arm B | 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) | Satisfaction from Treatment - DVN (Week 5) - No | 5.5 Percentage of participants |
| Arm B | 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) | A Little Satisfied (Week 5) | 26.4 Percentage of participants |
| Arm B | 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) | Very Satisfied (Week 5) | 58.2 Percentage of participants |
| Arm B | 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) | A Little Dissatisfied (Week 5) | 4.4 Percentage of participants |
| Arm B | 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) | Very Dissatisfied (Week 5) | 1.1 Percentage of participants |
| Arm B | 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) | Willingness to Continue - DVN (Week 5) - Yes | 89.0 Percentage of participants |
| Arm B | 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) | Willingness to Continue - DVN (Week 5) - No | 1.1 Percentage of participants |
| Arm B | 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) | A Little Bit Willing (Week 5) | 4.4 Percentage of participants |
| Arm B | 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) | Very Willing (Week 5) | 84.6 Percentage of participants |
| Arm B | 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) | A Little Unwilling (Week 5) | 0 Percentage of participants |
| Arm B | 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) | Very Unwilling (Week 5) | 1.1 Percentage of participants |
| Arm B | 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) | Benefit from Treatment - No benefit (Week 10) | 3.3 Percentage of participants |
| Arm B | 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) | Benefit from Treatment - Little benefit (Week 10) | 9.9 Percentage of participants |
| Arm B | 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) | Benefit from Treatment - Much benefit (Week 10) | 70.3 Percentage of participants |
| Arm B | 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) | Satisfaction from Treatment - DVN (Week 10) - Yes | 80.2 Percentage of participants |
| Arm B | 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) | Satisfaction from Treatment - DVN (Week 10) - No | 3.3 Percentage of participants |
| Arm B | 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) | A Little Satisfied (Week 10) | 11.0 Percentage of participants |
| Arm B | 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) | Very Satisfied (Week 10) | 69.2 Percentage of participants |
| Arm B | 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) | A Little Dissatisfied (Week 10) | 2.2 Percentage of participants |
| Arm B | 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) | Very Dissatisfied (Week 10) | 1.1 Percentage of participants |
| Arm B | 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) | Willingness to Continue - DVN (Week 10) - Yes | 81.3 Percentage of participants |
| Arm B | 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) | Willingness to Continue - DVN (Week 10) - No | 2.2 Percentage of participants |
| Arm B | 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) | A Little Bit Willing (Week 10) | 4.4 Percentage of participants |
| Arm B | 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) | Very Willing (Week 10) | 76.9 Percentage of participants |
| Arm B | 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) | A Little Unwilling (Week 10) | 0 Percentage of participants |
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10 | Week 5 (n=84, 82) | -1.75 Units on a scale | Standard Deviation 2.07 |
| Arm A | Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10 | Week 10 (n=81, 76) | -2.83 Units on a scale | Standard Deviation 2.26 |
| Arm B | Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10 | Week 5 (n=84, 82) | -1.68 Units on a scale | Standard Deviation 1.86 |
| Arm B | Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10 | Week 10 (n=81, 76) | -2.99 Units on a scale | Standard Deviation 2.45 |
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | 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 (n=84, 82) | -2.23 Units on a scale | Standard Deviation 3.78 |
| Arm A | Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6) | Week 10 (n=81, 76) | -3.09 Units on a scale | Standard Deviation 4.34 |
| Arm B | 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 (n=84, 82) | -1.91 Units on a scale | Standard Deviation 3.23 |
| Arm B | Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6) | Week 10 (n=81, 76) | -2.68 Units on a scale | Standard Deviation 4.08 |
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | 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 (n=84, 82) | -1.87 Units on a scale | Standard Deviation 4.18 |
| Arm A | Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6) | Week 10 (n=81, 76) | -2.57 Units on a scale | Standard Deviation 4.62 |
| Arm B | 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 (n=84, 82) | -1.35 Units on a scale | Standard Deviation 3.87 |
| Arm B | Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6) | Week 10 (n=81, 76) | -2.01 Units on a scale | Standard Deviation 3.84 |
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10 | Week 5 (n= 84, 82) | -21.3 Units on a scale | Standard Deviation 29.73 |
| Arm A | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10 | Week 10 (n= 81, 76) | -27.1 Units on a scale | Standard Deviation 25.7 |
| Arm B | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10 | Week 5 (n= 84, 82) | -16.5 Units on a scale | Standard Deviation 25.92 |
| Arm B | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10 | Week 10 (n= 81, 76) | -22.8 Units on a scale | Standard Deviation 25.04 |
Secondary
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.
Time frame: Baseline and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms | -3.21 Units on a scale | Standard Error 0.262 |
| Arm B | Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms | -3.45 Units on a scale | Standard Error 0.265 |
Comparison: Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.p-value: 0.512895% CI: [-0.48, 0.95]Mixed Models Analysis
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | 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(n= 85, 79) | -2.46 Units on a scale | Standard Error 0.235 |
| Arm A | 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 10(n=81, 75) | -3.69 Units on a scale | Standard Error 0.265 |
| Arm B | 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(n= 85, 79) | -2.12 Units on a scale | Standard Error 0.236 |
| Arm B | 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 10(n=81, 75) | -3.38 Units on a scale | Standard Error 0.268 |
Comparison: Statistical analysis at Week 5 compared between treatment groups.p-value: 0.285695% CI: [-0.97, 0.29]Mixed Models Analysis
Comparison: Statistical analysis at Week 10 compared between treatment groups.p-value: 0.398795% CI: [-1.02, 0.41]Mixed Models Analysis
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6). | 1.42 Units on a scale | Standard Error 0.204 |
Comparison: Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.p-value: <0.000195% CI: [1.02, 1.83]Mixed Models Analysis
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 (n=84, 82) | 2.69 Units on a scale | Standard Deviation 0.11 |
| Arm A | Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 (n=81, 76) | 2.31 Units on a scale | Standard Deviation 0.1 |
| Arm B | Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 (n=84, 82) | 2.64 Units on a scale | Standard Deviation 0.11 |
| Arm B | Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 (n=81, 76) | 2.11 Units on a scale | Standard Deviation 0.11 |
Comparison: Statistical analysis at Week 5 based on comparison between treatment groups.p-value: 0.725195% CI: [-0.22, 0.32]Mixed Models Analysis
Comparison: Statistical analysis at Week 10 based on comparison between treatment groups.p-value: 0.125595% CI: [-0.06, 0.46]Mixed Models Analysis
Secondary
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.
Time frame: Period 1 and Period 2
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 1 (n=88, 90) (Mild) | 19.1 % of days | Standard Deviation 27.88 |
| Arm A | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 2 (n=84, 81) (Mild) | 33.5 % of days | Standard Deviation 36.98 |
| Arm A | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 1 (n=88, 90) (Moderate) | 40.2 % of days | Standard Deviation 34.07 |
| Arm A | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 2 (n=84, 81) (Moderate) | 33.2 % of days | Standard Deviation 34.28 |
| Arm A | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 1 (n=88, 90) (Severe) | 38.8 % of days | Standard Deviation 40.11 |
| Arm A | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 2 (n=84, 81) (Severe) | 26.5 % of days | Standard Deviation 39.09 |
| Arm B | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 1 (n=88, 90) (Severe) | 44.8 % of days | Standard Deviation 40.76 |
| Arm B | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 1 (n=88, 90) (Mild) | 15.3 % of days | Standard Deviation 28.13 |
| Arm B | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 2 (n=84, 81) (Moderate) | 44.2 % of days | Standard Deviation 39.41 |
| Arm B | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 2 (n=84, 81) (Mild) | 25.0 % of days | Standard Deviation 34.5 |
| Arm B | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 2 (n=84, 81) (Severe) | 21.8 % of days | Standard Deviation 34.91 |
| Arm B | Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2 | Period 1 (n=88, 90) (Moderate) | 37.6 % of days | Standard Deviation 35.23 |
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 5) | 51.1 Percentage of participants |
| Arm A | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 5) | 48.9 Percentage of participants |
| Arm A | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 10) | 63.6 Percentage of participants |
| Arm A | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 10) | 31.8 Percentage of participants |
| Arm B | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 10) | 31.1 Percentage of participants |
| Arm B | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 5) | 35.6 Percentage of participants |
| Arm B | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 10) | 58.9 Percentage of participants |
| Arm B | Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 5) | 64.4 Percentage of participants |
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 5) | 25.0 Percentage of participants |
| Arm A | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 5) | 75.0 Percentage of participants |
| Arm A | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 10) | 42.0 Percentage of participants |
| Arm A | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 10) | 53.4 Percentage of participants |
| Arm B | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 10) | 52.2 Percentage of participants |
| Arm B | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 5) | 20.0 Percentage of participants |
| Arm B | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | Yes (Week 10) | 37.8 Percentage of participants |
| Arm B | Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10 | No (Week 5) | 80.0 Percentage of participants |
Secondary
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.
Time frame: Week 5 and Week 10
Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - very much improved(n=84, 82) | 11.9 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - much worse(n=84, 82) | 44.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - much improved(n=84, 82) | 31.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - minimally improved(n=84, 82) | 8.3 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - no change(n=84, 82) | 4.8 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - minimally worse(n=84, 82) | 0.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - very much worse(n=84, 82) | 0.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - missing(n=84, 82) | 0.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - very much improved(n=81, 76) | 25.9 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - much improved(n=81, 76) | 46.9 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - minimally improved(n=81, 76) | 21.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - no change(n=81, 76) | 4.9 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - minimally worse(n=81, 76) | 0.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - much worse(n=81, 76) | 1.2 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - very much worse(n=81, 76) | 0.0 percentage of participants |
| Arm A | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - missing(n=81, 76) | 0.0 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - missing(n=81, 76) | 0.0 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - very much improved(n=84, 82) | 12.2 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - very much improved(n=81, 76) | 31.6 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - much worse(n=84, 82) | 43.9 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - minimally worse(n=81, 76) | 1.3 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - much improved(n=84, 82) | 32.9 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - much improved(n=81, 76) | 51.3 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - minimally improved(n=84, 82) | 9.8 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - very much worse(n=81, 76) | 0.0 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - no change(n=84, 82) | 1.2 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - minimally improved(n=81, 76) | 15.8 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - minimally worse(n=84, 82) | 0.0 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - much worse(n=81, 76) | 0.0 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - very much worse(n=84, 82) | 0.0 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 10 - no change(n=81, 76) | 0.0 percentage of participants |
| Arm B | Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6) | Week 5 - missing(n=84, 82) | 0.0 percentage of participants |