Efficacy and Safety Study of Celecoxib and Pregabalin Com... | NCT01838044

NCT01838044

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental	The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.	Drug: pregabalin and celecoxib
Arm B	Other	The group of patients who are randomized to receive celecoxib monotherapy during the first study period.	Drug: Placebo and celecoxib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pregabalin and celecoxib	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and Week 5

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Maranhão - CEPEC		São Luís	Maranhão	65020-600	Brazil

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Safety population was composed of all participants who took at least one dose of study medication (either pregabalin or celecoxib).

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-2.18± 0.212 OG001-2.03± 0.212

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Statistical analysis at Week 5 compared between two study arms.	Mixed Models Analysis		0.6012		LS Mean Difference	-0.15	Standard Error of the Mean	0.287	2-Sided	95	-0.72	0.42					Superiority or Other (legacy)

Secondary

Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).

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

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 5 and Week 10

ID	Title	Description
OG000	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.

Secondary

Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms

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

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and Week 10

ID	Title	Description
OG000	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.
OG001	Arm B

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.

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

Posted

Number

Percentage of participants

Week 5 and Week 10

ID	Title	Description
OG000	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.

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.

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

Posted

Mean

Standard Deviation

Units on a scale

Week 5 and Week 10

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)

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

Posted

Number

percentage of participants

Week 5 and Week 10

ID	Title	Description
OG000	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.
OG001	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.

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.

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

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 5 and Week 10

ID	Title	Description
OG000	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.

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.

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

Posted

Mean

Standard Deviation

Units on a scale

Week 5 and Week 10

ID	Title	Description
OG000	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.
OG001	Arm B

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.

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

Posted

Mean

Standard Deviation

Units on a scale

Week 5 and Week 10

ID	Title	Description
OG000	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.
OG001	Arm B

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.

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

Posted

Mean

Standard Deviation

% of days

Period 1 and Period 2

ID	Title	Description
OG000	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.
OG001	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.

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.

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

Posted

Mean

Standard Deviation

Units on a scale

Week 5 and Week 10

ID	Title	Description
OG000	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.
OG001	Arm B

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.

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

Posted

Mean

Standard Deviation

Units on a scale

Week 5 and Week 10

ID	Title	Description
OG000	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.

Secondary

Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10

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

Posted

Number

Percentage of participants

Week 5 and Week 10

ID	Title	Description
OG000	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.
OG001	Arm B

Secondary

Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10

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

Posted

Number

Percentage of participants

Week 5 and Week 10

ID	Title	Description
OG000	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.
OG001	Arm B

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			0	89	28	89
EG001	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.			2	91	19	91

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 events0 affected89 at risk EG0012 events2 affected91 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dizziness	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG00012 affected89 at risk EG00112 affected91 at risk
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG00010 affected89 at risk EG0017 affected91 at risk
Somnolence	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG00012 affected89 at risk EG0017 affected91 at risk

The study was terminated as it had been determined that it was no longer operationally feasible to continue the trial. The study termination was not due to a safety issue or finding.

Certain Agreements

ID	Term
D000069583	Pregabalin
D000068579	Celecoxib

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

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.