Safety And Efficacy Study Of Once Daily Controlled Releas... | NCT01270828

ID	Type	Description	Link
2009-016766-86	EudraCT Number

Safety And Efficacy Study Of Once Daily Controlled Releas... | NCT01270828 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Pregablain CR tablet 82.5 to 660mg	Experimental		Drug: Pregabalin
Placebo	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks	Pregablain CR tablet 82.5 to 660mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Loss of Therapeutic Response.	Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.	13 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results	A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as: At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Fundamental Research		Gulf Shores	Alabama	36542	United States
Radiant Research, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27753650	Derived	Huffman CL, Goldenberg JN, Weintraub J, Sanin L, Driscoll J, Yang R, Chew ML, Scavone JM. Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients With Postherpetic Neuralgia: A Double-Blind, Enriched Enrollment Randomized Withdrawal, Placebo-Controlled Trial. Clin J Pain. 2017 Jul;33(7):569-578. doi: 10.1097/AJP.0000000000000445.

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pregabalin Controlled Release (CR) DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Reason Unspecified		FG0000 subjects FG0010 subjects FG0028 subjects
Enrolled but not treated		FG0000 subjects FG0010 subjects FG0025 subjects
Related adverse event		FG0000 subjects FG0010 subjects FG00246 subjects
Lack of Efficacy		FG0000 subjects FG0010 subjects FG00232 subjects
Withdrawal by Subject		FG0000 subjects FG0010 subjects FG00229 subjects
Lost to Follow-up		FG0000 subjects FG0010 subjects FG00210 subjects
Unrelated AE		FG0000 subjects FG0010 subjects FG0028 subjects
Protocol Violation		FG0000 subjects FG0010 subjects FG0028 subjects

Double Blind Phase

Type	Comment	Milestone Data
STARTED		FG000208 subjects FG001205 subjects FG0020 subjects
COMPLETED		FG000182 subjects FG001160 subjects FG0020 subjects
NOT COMPLETED		FG00026 subjects FG00145 subjects FG0020 subjects

Type	Comment	Reasons
Death		FG0000 subjects FG0011 subjects FG0020 subjects
Protocol Violation		FG000

Arm/Group Information

ID	Title	Description
BG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
BG001	Placebo DB	Participants received matching placebo
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, Customized

Number

Participants

Title

Denominators

Categories

<18 years

Title	Measurements
	BG0000 BG0010 BG0020

18-44 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000134 BG001122 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Loss of Therapeutic Response.

Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.

The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Number

Participants

13 Weeks

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants	OG000208 OG001205

Title

Denominators

Categories

Title	Measurements
	OG00029 OG00163

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	Kaplan-Meier method was used for the analysis.	Log Rank		<0.0001														Superiority or Other (legacy)

Secondary

Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results

A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:

At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score
A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase

Posted

Number

Participants

13 Weeks

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts

Secondary

Percentage of Participants With 30% Reduction in the Mean Pain Score.

The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Number

Percentage of participants

13 Weeks

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With 50% Reduction in the Mean Pain Score.

The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Number

Percentage of participants

13 Weeks

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Endpoint in Weekly Mean Pain Score.

The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Least Squares Mean

Standard Error

Units on a scale

SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants

Secondary

Change in the Weekly NRS-Pain (1-Week Recall).

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Least Squares Mean

Standard Error

Units on a scale

SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants

Secondary

Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).

The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. 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 assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.

Posted

Least Squares Mean

Standard Error

Units on a scale

SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB

Secondary

Change in the MOS-SS-Quantity of Sleep.

The item "Quantity of sleep" of MOS-SS is presented here.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Least Squares Mean

Standard Error

Hours

SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Secondary

The MOS-SS-Optimal Sleep.

The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The "percentage of participants with optimal sleep" is presented here.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Number

Percentage of participants

Week 6 and Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Secondary

Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score

The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Number

Percentage of participants

Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants

Secondary

Change in the Short Form 36 Health Survey (SF-36)

The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Secondary

Change in Mean Daily Sleep Interference Scores

The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units

Secondary

Change in Hospital Anxiety and Depression Scales (HADS)

The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Secondary

Change in the Brief Pain Inventory (BPI-sf)

The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts

Secondary

Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)

The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient'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 FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Number

Percentage of participants

Week 19

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective "severe" to those AEs that interfere significantly with participant's usual function.

The SB Analysis Set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Both SBAS and FAS were included in this analysis.

Posted

Number

Participants

Baseline to Week 20

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB

Secondary

Percentage of Participants With Suicidal Behaviour/Ideation

Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.

The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.

Posted

Number

Percentage of participants

Baseline, Weeks 6, 11, 15, 19 and 20

ID	Title	Description
OG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
OG001	Placebo DB	Participants received matching placebo

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pregabalin CR DB	Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.	7	208	7	208
EG001	Placebo DB	Participants received matching placebo	3	205	1	205
EG002	Pregabalin CR SB	The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.	17	801	202	801

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0001 affected208 at risk EG0010 affected205 at risk EG0020 affected801 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0011 affected205 at risk EG0020 affected801 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Cardiac failure	Cardiac disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0001 affected208 at risk EG0010 affected205 at risk EG0020 affected801 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Chest pain	General disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Acute sinusitis	Infections and infestations	MedDRA Version 18.0	Non-systematic Assessment	EG0001 affected208 at risk EG0010 affected205 at risk EG0020 affected801 at risk
Bronchopneumonia	Infections and infestations	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0011 affected205 at risk EG0020 affected801 at risk
Perirectal abscess	Infections and infestations	MedDRA Version 18.0	Non-systematic Assessment	EG0001 affected208 at risk EG0010 affected205 at risk EG0020 affected801 at risk
Septic shock	Infections and infestations	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Pneumonia	Infections and infestations	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Liver function test abnormal	Investigations	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
White blood cell count increased	Investigations	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0001 affected208 at risk EG0010 affected205 at risk EG0020 affected801 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0011 affected205 at risk EG0020 affected801 at risk
Sciatica	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0001 affected208 at risk EG0010 affected205 at risk EG0020 affected801 at risk
Syncope	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Renal mass	Renal and urinary disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0001 affected208 at risk EG0010 affected205 at risk EG0020 affected801 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk
Sexual abuse	Social circumstances	MedDRA Version 18.0	Non-systematic Assessment	EG0000 affected208 at risk EG0010 affected205 at risk EG0021 affected801 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Dizziness	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment		EG0007 affected208 at risk EG0011 affected205 at risk EG002137 affected801 at risk
Somnolence	Nervous system disorders	MedDRA Version 18.0	Non-systematic Assessment		EG0001 affected208 at risk EG0010 affected205 at risk EG00291 affected801 at risk

Ancestor Terms

ID	Term
D009437	Neuralgia
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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

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	Kaplan-Meier method was used for the analysis.	Log Rank		<0.0001														Superiority or Other (legacy)

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	Chi-square test was used for analysis.	Chi-squared		<0.0001														Superiority or Other (legacy)

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	Chi-square test was used for analysis.	Chi-squared		<0.0001														Superiority or Other (legacy)

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	This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.	ANCOVA		<0.0001		Mean Difference (Final Values)	-0.94	Standard Error of the Mean	0.16	2-Sided	95	-1.26	-0.62					Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.	ANCOVA		<0.0001		Mean Difference (Final Values)	-0.91	Standard Error of the Mean	0.15	2-Sided	95	-1.21	-0.61					Superiority or Other (legacy)

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	This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA		<0.0001		Mean Difference (Final Values)	-1.1			2-Sided	95	-1.47	-0.75					Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA		<0.0001		Mean Difference (Final Values)	-1.0			2-Sided	95	-1.34	-0.65					Superiority or Other (legacy)

Title

Denominators

Categories

Sleep Problems Index I-SB BL to wk 19(N=202,195)

Title	Measurements
	OG000-19.9± 1.09 OG001-16.7± 1.13

Sleep Problems Index I-DB BL to wk 19(N=202,195)

Title	Measurements
	OG0001.2± 1.05 OG0014.4± 1.09

SleepProblems Index II-SB BL to wk 19(N=202,195)

Title	Measurements
	OG000-21.2± 1.07 OG001-17.4± 1.11

SleepProblems Index II-DB BL to wk 19(N=202,194)

Title	Measurements
	OG0000.2± 1.01 OG0014.3± 1.05

Sleep Disturbance-SB BL to wk 19

Title	Measurements
	OG000-28.3± 1.42 OG001-21.1± 1.48

Sleep Disturbance-DB BL to wk 19

Title	Measurements
	OG000-1.1± 1.31 OG0017.6± 1.36

Snoring-SB BL to wk 19(N=202,194)

Title	Measurements
	OG000-3.3± 1.57 OG001-4.7± 1.64

Snoring-DB BL to wk 19(N=201,194)

Title	Measurements
	OG000-0.6± 1.41 OG0010.8± 1.46

Awaken short of breath/headache-SB BL to wk 19

Title	Measurements
	OG000-11.9± 1.21 OG001-10.4± 1.26

Awaken short of breath/headache-DB BL to wk 19

Title	Measurements
	OG000-1.2± 1.23 OG001-0.2± 1.27

Sleep adequacy-SB BL to wk 19

Title	Measurements
	OG00019.9± 1.83 OG00117.5± 1.90

Sleep adequacy-DB BL to wk 19(N=202,195)

Title	Measurements
	OG000-3.3± 1.82 OG001-6.0± 1.89

Somnolence-SB BL to wk 19(N=202,195)

Title	Measurements
	OG000-12.0± 1.19 OG001-12.0± 1.23

Somnolence-DB BL to wk 19(N=203,194)

Title	Measurements
	OG000-0.7± 1.15 OG001-0.9± 1.19

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0324	Mean Difference (Final Values)	-3.2	2-Sided	95	-6.1	-0.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0223	Mean Difference (Final Values)	-3.3	2-Sided	95	-6.1	-0.5	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0098	Mean Difference (Final Values)	-3.8	2-Sided	95	-6.6	-0.9	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0033	Mean Difference (Final Values)	-4.0	2-Sided	95	-6.7	-1.4	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0002	Mean Difference (Final Values)	-7.3	2-Sided	95	-11.1	-3.5	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	<0.0001	Mean Difference (Final Values)	-8.7	2-Sided	95	-12.2	-5.2	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.5264	Mean Difference (Final Values)	1.4	2-Sided	95	-2.8	5.6	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.4520	Mean Difference (Final Values)	-1.4	2-Sided	95	-5.2	2.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.3714	Mean Difference (Final Values)	-1.5	2-Sided	95	-4.7	1.8	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.5639	Mean Difference (Final Values)	-1.0	2-Sided	95	-4.2	2.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.3223	Mean Difference (Final Values)	2.5	2-Sided	95	-2.4	7.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.2742	Mean Difference (Final Values)	2.7	2-Sided	95	-2.2	7.6	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.9816	Mean Difference (Final Values)	0.0	2-Sided	95	-3.2	3.1	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.9282	Mean Difference (Final Values)	0.1	2-Sided	95	-2.9	3.2	Superiority or Other (legacy)

Title

Denominators

Categories

Quantity of sleep-SB BL to wk 19(N=203,192)

Title	Measurements
	OG0000.9± 0.09 OG0010.7± 0.10

Quantity of sleep-DB BL to wk 19(N=202,192)

Title	Measurements
	OG000-0.1± 0.08 OG001-0.4± 0.09

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	This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA		0.1635		Mean Difference (Final Values)	0.2			2-Sided	95	-0.1	0.4					Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA		0.0363		Mean Difference (Final Values)	0.2				95	0.0	0.5					Superiority or Other (legacy)

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	This analysis is for Week 6	Chi-squared		0.432														Superiority or Other (legacy)
OG000 OG001	This analysis is for Week 19	Chi-squared		0.987														Superiority or Other (legacy)

Title

Denominators

Categories

Very much improved

Title	Measurements
	OG00031.5 OG00123.1

Much improved

Title	Measurements
	OG00036.9 OG00130.3

Minimally improved

Title	Measurements
	OG00016.7 OG00119.0

No change

Title	Measurements
	OG00010.3 OG00112.8

Minimally worse

Title	Measurements
	OG0002.5 OG0017.2

Much worse

Title	Measurements
	OG0001.5 OG0017.2

Very much worse

Title	Measurements
	OG0000.5 OG0010.5

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	This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.	Regression, Logistic		0.0007		Odds Ratio (OR)	1.85			2-Sided	95	1.30	2.65			Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB. Odds ratio > 1 is in favor of Pregabalin DB.		Superiority or Other (legacy)
OG000 OG001	This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.	Regression, Logistic		0.0009		Odds Ratio (OR)	2.32			2-Sided	95	1.41	3.81			Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB. Odds ratio > 1 is in favor of Pregabalin DB.		Superiority or Other (legacy)

Title

Denominators

Categories

Physical Component-SB BL to wk 19(N=202,195)

Title	Measurements
	OG0007.5± 0.54 OG0015.6± 0.56

Physical Component-DB BL to wk 19(N=202,195)

Title	Measurements
	OG0000.1± 0.51 OG001-2.3± 0.53

Mental Component-SB BL to wk 19(N=202,195)

Title	Measurements
	OG0006.4± 0.62 OG0015.5± 0.64

Mental Component-DB BL to wk 19(N=202,195)

Title	Measurements
	OG000-1.1± 0.62 OG001-2.2± 0.64

Physical functioning-SB BL to wk 19

Title	Measurements
	OG00011.7± 1.44 OG0018.9± 1.49

Physical functioning-DB BL to wk 19

Title	Measurements
	OG000-1.4± 1.25 OG001-4.9± 1.29

Role-Physical-SB BL to wk 19

Title	Measurements
	OG00018.9± 1.62 OG00113.9± 1.67

Role-Physical-DB BL to wk 19

Title	Measurements
	OG000-2.4± 1.54 OG001-7.7± 1.60

Bodily pain-SB BL to wk 19

Title	Measurements
	OG00031.0± 1.51 OG00123.6± 1.56

Bodily pain-DB BL to wk 19

Title	Measurements
	OG0001.4± 1.38 OG001-6.2± 1.43

General Health Perception-SB BL to wk19(N=202,195)

Title	Measurements
	OG00011.3± 1.05 OG0018.2± 1.08

General Health Perception-DB BL to wk19(N=202,195)

Title	Measurements
	OG0001.4± 0.96 OG001-4.0± 1.00

Vitality-SB BL to wk 19(N=202,195)

Title	Measurements
	OG00013.7± 1.25 OG00110.7± 1.30

Vitality-DB BL to wk 19(N=202,195)

Title	Measurements
	OG000-3.5± 1.21 OG001-6.5± 1.25

Social Functioning-SB BL to wk 19

Title	Measurements
	OG00018.5± 1.35 OG00115.7± 1.39

Social Functioning-DB BL to wk 19

Title	Measurements
	OG000-2.1± 1.28 OG001-4.3± 1.32

Role-Emotional-SB BL to wk 19

Title	Measurements
	OG00015.0± 1.43 OG00111.6± 1.47

Role-Emotional-DB BL to wk 19

Title	Measurements
	OG000-1.4± 1.42 OG001-5.4± 1.47

Mental Health-SB BL to wk 19(N=202,195)

Title	Measurements
	OG00011.1± 1.05 OG0019.5± 1.08

Mental Health-DB BL to wk 19(N=202,195)

Title	Measurements
	OG000-1.3± 1.04 OG001-3.7± 1.08

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0003	Mean Difference (Final Values)	7.4	2-Sided	95	3.4	11.5	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	<0.0001	Mean Difference (Final Values)	7.7	2-Sided	95	4.0	11.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0275	Mean Difference (Final Values)	3.2	2-Sided	95	0.4	6.0	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	<0.0001	Mean Difference (Final Values)	5.4	2-Sided	95	2.8	8.0	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0735	Mean Difference (Final Values)	3.0	2-Sided	95	-0.3	6.4	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0684	Mean Difference (Final Values)	3.0	2-Sided	95	-0.2	6.2	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.1197	Mean Difference (Final Values)	2.8	2-Sided	95	-0.7	6.4	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.2210	Mean Difference (Final Values)	2.1	2-Sided	95	-1.3	5.5	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0847	Mean Difference (Final Values)	3.3	2-Sided	95	-0.5	7.1	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0365	Mean Difference (Final Values)	4.0	2-Sided	95	0.3	7.8	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.2749	Mean Difference (Final Values)	1.6	2-Sided	95	-1.2	4.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0806	Mean Difference (Final Values)	2.5	2-Sided	95	-0.3	5.2	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0082	Mean Difference (Final Values)	2.0	2-Sided	95	0.5	3.4	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0008	Mean Difference (Final Values)	2.3	2-Sided	95	1.0	3.7	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.2097	Mean Difference (Final Values)	0.9	2-Sided	95	-0.8	2.5	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.1669	Mean Difference (Final Values)	1.2	2-Sided	95	-0.5	2.8	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.1466	Mean Difference (Final Values)	2.8	2-Sided	95	-1.0	6.7	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0439	Mean Difference (Final Values)	3.4	2-Sided	95	0.1	6.7	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0250	Mean Difference (Final Values)	4.9	2-Sided	95	0.6	9.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0107	Mean Difference (Final Values)	5.4	2-Sided	95	1.3	9.5	Superiority or Other (legacy)

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	This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.	ANCOVA		<0.0001		Mean Difference (Final Values)	-0.9			2-Sided	95	-1.23	-0.64					Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.	ANCOVA		<0.0001		Mean Difference (Final Values)	-0.9			2-Sided	95	-1.12	-0.58					Superiority or Other (legacy)

Title

Denominators

Categories

HADS-Anxiety-SB Baseline to Week 19

Title	Measurements
	OG000-1.8± 0.21 OG001-1.1± 0.21

HADS-Anxiety-DB Baseline to Week 19

Title	Measurements
	OG0000.1± 0.19 OG0010.9± 0.20

HADS-Depression-SB Baseline to Week 19

Title	Measurements
	OG000-1.8± 0.20 OG001-1.2± 0.21

HADS-Depression-DB Baseline to Week 19

Title	Measurements
	OG0000.2± 0.19 OG0010.8± 0.19

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0154	Mean Difference (Final Values)	-0.7	2-Sided	95	-1.2	-0.1	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0027	Mean Difference (Final Values)	-0.8	2-Sided	95	-1.3	-0.3	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0166	Mean Difference (Final Values)	-0.7	2-Sided	95	-1.2	-0.1	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	0.0217	Mean Difference (Final Values)	-0.6	2-Sided	95	-1.1	-0.1	Superiority or Other (legacy)

Title

Denominators

Categories

Pain Severity Index-SB Baseline to Week 19

Title	Measurements
	OG000-18.0± 0.47 OG001-13.8± 0.49

Pain Severity Index-DB Baseline to Week 19

Title	Measurements
	OG000-0.7± 0.43 OG0013.1± 0.44

Pain Interference Index-SB Baseline to Week 19

Title	Measurements
	OG000-21.9± 0.71 OG001-17.2± 0.74

Pain Interference Index-DB Baseline to Week 19

Title	Measurements
	OG000-0.2± 0.67 OG0014.0± 0.70

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	<0.0001	Mean Difference (Final Values)	-4.2	2-Sided	95	-5.5	-3.0	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	<0.0001	Mean Difference (Final Values)	-3.8	2-Sided	95	-5.0	-2.7	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	<0.0001	Mean Difference (Final Values)	-4.6	2-Sided	95	-6.5	-2.7	Superiority or Other (legacy)
OG000 OG001	This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.	ANCOVA	<0.0001	Mean Difference (Final Values)	-4.2	2-Sided	95	-6.0	-2.4	Superiority or Other (legacy)

Title

Denominators

Categories

Benefit from treatment

Title	Measurements
	OG00098.5 OG00193.3

Satisfaction with treatment

Title	Measurements
	OG00096.0 OG00190.7

Willingness to continue treatment

Title	Measurements
	OG00087.6 OG00181.3

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.	Regression, Logistic	0.0161	Odds Ratio (OR)	4.77	2-Sided	95	1.34	17.00	Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.	Superiority or Other (legacy)
OG000 OG001	This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.	Regression, Logistic	0.0378	Odds Ratio (OR)	2.48	2-Sided	95	1.05	5.85	Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.	Superiority or Other (legacy)
OG000 OG001	This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.	Regression, Logistic	0.0901	Odds Ratio (OR)	1.61	2-Sided	95	0.93	2.81	Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.	Superiority or Other (legacy)

Title

Denominators

Categories

Participants with AEs

Title	Measurements
	OG00080 OG00163 OG002441

Participants with Serious AEs

Title	Measurements
	OG0007 OG0013 OG00217

Participants with Severe AEs

Title	Measurements
	OG0009 OG0013 OG00235

Title

Denominators

Categories

SB BL(N=208,205)

Title	Measurements
	OG0000 OG0010.5

Week 6 (N=208,205)

Title	Measurements
	OG0000 OG0010

Week 11 (N=194,178)

Title	Measurements
	OG0000 OG0010

Week 15 (N=183,167)

Title	Measurements
	OG0000 OG0010

Week 19 (N=204,197)

Title	Measurements
	OG0000 OG0010

Week 20 (N=199,194)

Title	Measurements
	OG0000 OG0010