Effect Of Pregabalin Treatment In Patients With Diabetic... | NCT01455415

ID	Type	Description	Link
2011-002743-10	EudraCT Number

Effect Of Pregabalin Treatment In Patients With Diabetic... | NCT01455415 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1: Pregabalin	Experimental		Drug: pregabalin
2: Placebo	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
pregabalin	Drug	150 - 300 mg/day in divided dose (3 time a day) for 6 weeks	1: Pregabalin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)	The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.	End of Period (includes both Visits 5 and 9)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)	Daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Dedicated Clinical Research		Goodyear	Arizona	85395	United States
Clinical Research Consortium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25968451	Derived	Raskin P, Huffman C, Yurkewicz L, Pauer L, Scavone JM, Yang R, Parsons B. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. Clin J Pain. 2016 Mar;32(3):203-10. doi: 10.1097/AJP.0000000000000254.

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/Placebo	Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event (AE) Related to Study Drug		FG0009 subjects FG0016 subjects
Lost To Follow-up Related to Study Drug		FG0003 subjects FG0013 subjects
Drug Error not Associated to AE		FG0000 subjects FG0011 subjects
AE Not Related to Study Drug		FG0002 subjects FG0016 subjects
Withdrawal by Subject		FG0004 subjects FG0015 subjects
Unspecified Reason		FG0001 subjects FG0011 subjects
Protocol Violation		FG0000 subjects FG0012 subjects

Washout

Type	Comment	Milestone Data
STARTED		FG000135 subjects FG001123 subjects
COMPLETED		FG000127 subjects FG001116 subjects
NOT COMPLETED		FG0008 subjects FG0017 subjects

Type	Comment	Reasons
AE Related to Study Drug		FG0002 subjects FG0010 subjects
Lost to Follow-up		FG0001 subjects FG001

Period 2

Type	Comment	Milestone Data
STARTED		FG000127 subjects FG001116 subjects
COMPLETED		FG000114 subjects FG001106 subjects
NOT COMPLETED		FG00013 subjects FG00110 subjects

Type	Comment	Reasons
AE Related to Study Drug		FG0001 subjects FG0012 subjects
Lost to Follow-up		FG0002 subjects FG001

Follow-up

Type	Comment	Milestone Data
STARTED		FG000114 subjects FG001106 subjects
COMPLETED		FG000111 subjects FG001104 subjects
NOT COMPLETED		FG0003 subjects FG0012 subjects

Type	Comment	Reasons
AE Related to Study Drug		FG0000 subjects FG0011 subjects
Lack of Efficacy		FG0000 subjects FG001

Arm/Group Information

ID	Title	Description
BG000	Pregabalin/Placebo	Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
BG001	Placebo/Pregablin	Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
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
	BG00059.4± 9.8 BG00158.4± 9.5 BG00258.9± 9.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00065 BG00172 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

Secondary

Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.

The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.

Posted

Number

percentage of participants

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001	Placebo	The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Units	Counts
Participants	OG000272 OG001276

Title

Denominators

Categories

Title	Measurements
	OG00034.56 OG00131.16

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	Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.	Regression, Logistic		0.3287	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Odds Ratio (OR)	1.20			2-Sided	95	0.83	1.73					Superiority or Other (legacy)

Secondary

Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Posted

Number

percentage of participants

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)

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. Four items measure pain (0: no pain; 10: worst pain possible) at its "worst, "least", "average", and "now" (current pain) on an 11-point scale. Scores range from 0 - 10 with higher scores indicating greater pain severity.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001	Placebo

Secondary

BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)

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. Seven sub-questions evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on an 11-point scale (0: does not interfere; 10: completely interferes). Scores range from 0 - 10 with higher scores indicating greater interference.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001

Secondary

Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates "does not interfere with sleep" and 10 indicates "completely interferes (unable to sleep due to pain)". Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001	Placebo

Secondary

Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

The Hospital Anxiety and Depression Scale (HADS) is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

HADS is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001	Placebo

Secondary

Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The (sub)scales are calculated without weighting of any kind, and reported as the integer sum of listed questionnaire items (range: -4 - 136). The QOL-DN version that was administered in this study was modified with a 2-week recall period.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. Item 9 is scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). The symptoms domain score should be summed as follow: Σ (1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 32). The QOL-DN version that was administered in this study was modified with a 2-week recall period.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). Activities of the daily living domain score should be summed as follow: Σ (12, 22, 23, 25, 26). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: 0 - 20). The QOL-DN version that was administered in the study was modified with a 2-week recall period.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. With exception of questions 31 and 32, items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", middle item, is scored as 0, "very good" as -1 , "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. Physical functioning / large fiber domain score should be summed as follow: Σ (8, 11, 13 - 15, 24, 27 - 35). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: -4 - 56). QOL-DN version that was administered in the study was modified with a 2-week recall period.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). The small fiber domain score should be summed as follow: Σ (10, 16, 17, 18). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of the listed questionnaire items (range: 0 - 16). The QOL-DN version that was administered in this study was modified with a 2-week recall period.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). The autonomic domain score should be summed as follow: Σ (19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 12). The QOL-DN version that was administered in this study was modified with a 2-week recall period.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale (no problems, some/moderate problems, extreme problems) and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001

Secondary

EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001	Placebo

Secondary

EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001

Secondary

EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001

Secondary

EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001

Secondary

EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores

Posted

Number

percentage of participants

End of Period 1 (V5)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
OG001	Placebo	The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Primary

Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)

The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.

Posted

Least Squares Mean

Standard Error

units on a scale

End of Period (includes both Visits 5 and 9)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Secondary

PGIC Score at the End of Period 1 (Week 6) - Categorized Scores

The PGIC is a participant-rated instrument that measures the participant's assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (7 different scores) and categorized scores (4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).

Posted

Number

percentage of participants

End of Period 1 (V5)

ID	Title	Description
OG000	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

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	Pregabalin	The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.			5	272	84	272
EG001	Placebo	The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.			7	276	45	276

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA v17.0	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v17.0	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk
Myocardial infarction	Cardiac disorders	MedDRA v17.0	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk
Gastritis	Gastrointestinal disorders	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk
Multi-organ failure	General disorders	MedDRA v17.0	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk
Bronchitis	Infections and infestations	MedDRA v17.0	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA v17.0	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk
Localised infection	Infections and infestations	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk
Lung abscess	Infections and infestations	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v17.0	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk
Hypertension	Vascular disorders	MedDRA v17.0	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA v17.0	Non-systematic Assessment	EG0009 affected272 at risk EG00111 affected276 at risk
Nausea	Gastrointestinal disorders	MedDRA v17.0	Non-systematic Assessment	EG0009 affected272 at risk EG0018 affected276 at risk
Fatigue	General disorders	MedDRA v17.0	Non-systematic Assessment	EG00014 affected272 at risk EG0014 affected276 at risk
Oedema peripheral	General disorders	MedDRA v17.0	Non-systematic Assessment	EG00010 affected272 at risk EG0018 affected276 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v17.0	Non-systematic Assessment	EG0008 affected272 at risk EG0014 affected276 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v17.0	Non-systematic Assessment	EG0007 affected272 at risk EG0015 affected276 at risk
Dizziness	Nervous system disorders	MedDRA v17.0	Non-systematic Assessment	EG00028 affected272 at risk EG0014 affected276 at risk
Headache	Nervous system disorders	MedDRA v17.0	Non-systematic Assessment	EG0009 affected272 at risk EG0018 affected276 at risk
Somnolence	Nervous system disorders	MedDRA v17.0	Non-systematic Assessment	EG00014 affected272 at risk EG0017 affected276 at risk

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	Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.	Regression, Logistic		0.0625	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Odds Ratio (OR)	1.57			2-Sided	95	0.98	2.51					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	Analysis was done using a linear mixed effects model which included baseline pain severity, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.9448	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	0.01	Standard Error of the Mean	0.11	2-Sided	95	-0.21	0.22					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	Analysis was done using a linear mixed effects model which included baseline interference score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.4548	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.09	Standard Error of the Mean	0.12	2-Sided	95	-0.32	0.14					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	Analysis was done using linear mixed effects model including baseline score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.	Mixed Models Analysis		0.0272	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.24	Standard Error of the Mean	0.11	2-Sided	95	-0.44	-0.03					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	Analysis was done using a linear mixed effects model which included baseline HADS-A score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.7344	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.06	Standard Error of the Mean	0.18	2-Sided	95	-0.42	0.30					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	Analysis was done using a linear mixed effects model which included baseline HADS-D score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.6007	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.09	Standard Error of the Mean	0.17	2-Sided	95	-0.42	0.24					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	Analysis was done using a linear mixed effects model which included baseline total score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.2987	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-1.08	Standard Error of the Mean	1.04	2-Sided	95	-3.13	0.96					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	Analysis was done using a linear mixed effects model which included baseline symptoms domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.1769	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.35	Standard Error of the Mean	0.26	2-Sided	95	-0.85	0.16					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	Analysis was done using a linear mixed effects model which included baseline activities of daily living domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.5119	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.12	Standard Error of the Mean	0.18	2-Sided	95	-0.48	0.24					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	Analysis was done using a linear mixed effects model which included baseline physical functioning / large fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.4335	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.49	Standard Error of the Mean	0.62	2-Sided	95	-1.72	0.74					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	Analysis was done using a linear mixed effects model which included baseline small fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.9653	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.01	Standard Error of the Mean	0.16	2-Sided	95	-0.31	0.30					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	Analysis was done using a linear mixed effects model which included baseline autonomic domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.2690	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.14	Standard Error of the Mean	0.12	2-Sided	95	-0.38	0.11					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	Analysis was done using a linear mixed effects model which included baseline mobility domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.9951	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	0.00	Standard Error of the Mean	0.03	2-Sided	95	-0.05	0.05					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	Analysis was done using a linear mixed effects model which included baseline self-care domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.9726	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	0.00	Standard Error of the Mean	0.02	2-Sided	95	-0.05	0.05					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	Analysis was done using a linear mixed effects model which included baseline usual activities domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.5497	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	0.02	Standard Error of the Mean	0.03	2-Sided	95	-0.04	0.08					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	Analysis was done using a linear mixed effects model which included baseline pain / discomfort domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.1495	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	0.05	Standard Error of the Mean	0.03	2-Sided	95	-0.02	0.11					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	Analysis was done using a linear mixed effects model which included baseline anxiety / depression domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.1297	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.05	Standard Error of the Mean	0.03	2-Sided	95	-0.11	0.01					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	Analysis was done using a linear mixed effects model which included baseline Dolan 1997 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.4279	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.01	Standard Error of the Mean	0.01	2-Sided	95	-0.04	0.02					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	Analysis was done using a linear mixed effects model which included baseline Dolan 2001 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.	Mixed Models Analysis		0.5505	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.	Mean Difference (Final Values)	-0.01	Standard Error of the Mean	0.01	2-Sided	95	-0.04	0.02					Superiority or Other (legacy)

Title

Denominators

Categories

Very much improved

Title	Measurements
	OG0008.1 OG0014.9

Much improved

Title	Measurements
	OG00027.7 OG00119.6

Minimally improved

Title	Measurements
	OG00039.2 OG00139.2

No change

Title	Measurements
	OG00014.9 OG00123.1

Minimally worse

Title	Measurements
	OG0006.1 OG0017.0

Much worse

Title	Measurements
	OG0002.0 OG0011.4

Very much worse

Title	Measurements
	OG0001.4 OG0012.1

Missing

Title	Measurements
	OG0000.7 OG0012.8

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	Analysis was done using a Cochran-Mantel-Haenszel (CMH) test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.	Cochran-Mantel-Haenszel		0.0604	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.					2-Sided								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	A longitudinal analysis was done using a repeated measure linear mixed effects model including visit, treatment, an indicator variable for Week 6, and treatment by visit and by the indicator variable interaction as fixed effect factors and participant within sequence and within-participant error (estimated by using an unstructured covariance structure) as random factors. The treatment differences were tested using within-participant variability as the error term.	Repeated measure mixed effects model	The Kenward-Roger method was used to estimate denominator degrees of freedom.	0.7174	Primary analysis was two-sided and performed at the 0.05 significance level.	Mean Difference (Final Values)	-0.038	Standard Error of the Mean	0.106	2-Sided	95	-0.248	0.171					Superiority or Other (legacy)

Title

Denominators

Categories

Very much/much improved

Title	Measurements
	OG00035.8 OG00124.5

Any improvement

Title	Measurements
	OG00075.0 OG00163.6

No change

Title	Measurements
	OG00014.9 OG00123.1

Any worsening

Title	Measurements
	OG0009.5 OG00110.5

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	Analysis was done using a CMH test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.	Cochran-Mantel-Haenszel		0.1511	Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.					2-Sided								Superiority or Other (legacy)