Trial Outcomes & Findings for Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component (NCT NCT01838044)

NCT ID: NCT01838044

Last Updated: 2021-01-28

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: Baseline and Week 5
• Results posted on: 2021-01-28

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	89	91
Overall Study COMPLETED	81	75
Overall Study NOT COMPLETED	8	16

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	4	6
Overall Study Protocol Violation	3	3
Overall Study Withdrawal by Subject	0	2
Overall Study Insufficient clinical response	1	2
Overall Study Medication error without associated AE	0	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.	Total n=180 Participants Total of all reporting groups
Age, Continuous	49.7 Years STANDARD_DEVIATION 11.7 • n=93 Participants	49.2 Years STANDARD_DEVIATION 12.2 • n=4 Participants	49.5 Years STANDARD_DEVIATION 11.9 • n=27 Participants
Sex: Female, Male Female	65 Participants n=93 Participants	63 Participants n=4 Participants	128 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	28 Participants n=4 Participants	52 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	-2.03 Units on a scale Standard Error 0.212

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=91 Participants 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.	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.
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	—

SECONDARY outcome

Timeframe: Baseline and Week 10

Population: The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	-3.45 Units on a scale Standard Error 0.265

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	4.4 Percentage of participants
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	0 Percentage of participants
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	6.6 Percentage of participants
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	29.7 Percentage of participants
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	53.8 Percentage of participants
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	84.6 Percentage of participants
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	5.5 Percentage of participants
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	26.4 Percentage of participants
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	58.2 Percentage of participants
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	4.4 Percentage of participants
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	1.1 Percentage of participants
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	89.0 Percentage of participants
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	1.1 Percentage of participants
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	4.4 Percentage of participants
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	84.6 Percentage of participants
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	0 Percentage of participants
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	1.1 Percentage of participants
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	3.3 Percentage of participants
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	9.9 Percentage of participants
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	70.3 Percentage of participants
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	80.2 Percentage of participants
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	3.3 Percentage of participants
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	11.0 Percentage of participants
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	69.2 Percentage of participants
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	2.2 Percentage of participants
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	1.1 Percentage of participants
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	81.3 Percentage of participants
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	2.2 Percentage of participants
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	76.9 Percentage of participants
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	2.2 Percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	2.64 Units on a scale Standard Deviation 0.11
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 0.10	2.11 Units on a scale Standard Deviation 0.11

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	9.8 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	51.3 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	12.2 percentage of participants
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	43.9 percentage of participants
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	32.9 percentage of participants
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	1.2 percentage of participants
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	0.0 percentage of participants
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	31.6 percentage of participants
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	15.8 percentage of participants
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	0.0 percentage of participants
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	1.3 percentage of participants
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	0.0 percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	-2.12 Units on a scale Standard Error 0.236
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	-3.38 Units on a scale Standard Error 0.268

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	-1.91 Units on a scale Standard Deviation 3.23
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	-2.68 Units on a scale Standard Deviation 4.08

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	-1.35 Units on a scale Standard Deviation 3.87
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	-2.01 Units on a scale Standard Deviation 3.84

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	44.2 % of days Standard Deviation 39.41
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	15.3 % of days Standard Deviation 28.13
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	25.0 % of days Standard Deviation 34.50
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	37.6 % of days Standard Deviation 35.23
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	44.8 % of days Standard Deviation 40.76
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	21.8 % of days Standard Deviation 34.91

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	-1.68 Units on a scale Standard Deviation 1.86
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	-2.99 Units on a scale Standard Deviation 2.45

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=89 Participants 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.	Arm B n=91 Participants 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.
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	-16.5 Units on a scale Standard Deviation 25.92
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 25.70	-22.8 Units on a scale Standard Deviation 25.04

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=88 Participants 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.	Arm B n=90 Participants 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.
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	35.6 Percentage of participants
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	64.4 Percentage of participants
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	58.9 Percentage of participants
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	31.1 Percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm A n=88 Participants 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.	Arm B n=90 Participants 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.
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	20.0 Percentage of participants
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	37.8 Percentage of participants
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	80.0 Percentage of participants
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	52.2 Percentage of participants

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Arm B

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A n=89 participants at risk 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.	Arm B n=91 participants at risk 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/89 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.	2.2% 2/91 • Number of events 2 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.

Other adverse events

Measure	Arm A n=89 participants at risk 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.	Arm B n=91 participants at risk 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.
Nervous system disorders Dizziness	13.5% 12/89 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.	13.2% 12/91 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.
Nervous system disorders Headache	11.2% 10/89 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.	7.7% 7/91 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.
Nervous system disorders Somnolence	13.5% 12/89 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.	7.7% 7/91 • Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER