P4 (Pregabalin for Peripheral Posttraumatic Pain) | NCT00292188

Label	Type	Description	Intervention Names
Active	Experimental		Drug: pregabalin
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
pregabalin	Drug	pregabalin	Active
Placebo

Measure	Description	Time Frame
Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary	Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.	each day of Week 8

Measure	Description	Time Frame
Hospital Anxiety and Depression Scale (HADS) Anxiety Score	Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Brussels		1070	Belgium
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
21439051	Derived	van Seventer R, Serpell M, Bach FW, Morlion B, Zlateva G, Bushmakin AG, Cappelleri JC, Nimour M. Relationships between changes in pain severity and other patient-reported outcomes: an analysis in patients with posttraumatic peripheral neuropathic pain. Health Qual Life Outcomes. 2011 Mar 25;9:17. doi: 10.1186/1477-7525-9-17.

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

ID	Title	Description
FG000	Single-Blind Placebo	All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
FG001	Double-Blind Pregabalin

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

Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary

Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.

Full Analysis Set (FAS): all randomized subjects who received >= 1 dose study drug & have post-randomization efficacy data. Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

Standard Error

score on a scale

each day of Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts
Participants	OG000126 OG001125

Title

Denominators

Categories

Title	Measurements
	OG0004.61± 0.18 OG0015.23± 0.18

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	The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.	ANCOVA	ANCOVA adjusted for treatment group, baseline mean pain score and pooled country	0.010		Mean Difference (Final Values)	-0.62	Standard Error of the Mean	0.24		95	-1.09	-0.15					Superiority or Other (legacy)

Secondary

Hospital Anxiety and Depression Scale (HADS) Anxiety Score

Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety

Full analysis set (FAS), last observation carried forward (LOCF)

Posted

Least Squares Mean

Standard Error

score on scale

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Hospital Anxiety and Depression Scale (HADS) Depression Score

Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response ("lowering of hedonic tone"). Score range = 0 to 21; higher scores indicate a greater intensity of depression

FAS LOCF

Posted

Least Squares Mean

Standard Error

score on scale

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores

Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.

Posted

Least Squares Mean

Standard Error

score on scale

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores

Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression

Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.

Posted

Least Squares Mean

Standard Error

score on scale

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Weekly Mean Pain Score From Daily Pain Diary

Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.

FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively

Posted

Least Squares Mean

Standard Error

score on scale

Baseline through Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts
Participants

Secondary

Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)

Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.

FAS, LOCF.

Posted

Number

participants

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Weekly Mean Sleep Interference Score

11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.

FAS, LOCF

Posted

Least Squares Mean

Standard Error

score on scale

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts
Participants

Secondary

Medical Outcome Study (MOS) Sleep Subscales

Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.

FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.

Posted

Least Squares Mean

Standard Error

score on a scale

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Medical Outcome Study (MOS) Optimal Sleep

Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.

FAS, LOCF.

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts
Participants

Secondary

Patient Global Impression of Change (PGIC)

Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.

FAS, LOCF

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts
Participants

Secondary

Clinical Global Impression of Change (CGIC)

Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.

FAS, LOCF

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts
Participants

Secondary

Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication

Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.

FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on a scale

Screening, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication

Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.

FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on scale

Screening, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics

Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.

FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on scale

Screening, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Pain Treatment Satisfaction Scale (PTSS): Efficacy

Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.

FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on scale

Screening, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Modified Brief Pain Inventory Short Form (m-BPI-sf)

Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.

Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score

Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.

FAS. Number of subjects with a non-missing NPSI Total Intensity Score at Baseline and Week 8 (using LOCF) is 100, 106 for pregabalin, placebo respectively.

Posted

Least Squares Mean

Standard Error

percentage score on scale

Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Secondary

Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning

The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.

FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.

Posted

Number

participants

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration

FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.

Posted

Number

participants

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion

FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.

Posted

Number

particpants

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory

FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.

Posted

Number

participants

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention

FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.

Posted

Number

participants

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking

FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.

Posted

Number

participants

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units	Counts

Secondary

Davidson Trauma Scale (DTS): Severity

Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.

FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units

Secondary

Davidson Trauma Scale (DTS): Frequency

FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units

Secondary

Davidson Trauma Scale (DTS): Total Score

FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 8

ID	Title	Description
OG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
OG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.

Units

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Blood calcium increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Blood cholesterol increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Palpitations	Cardiac disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0014 affected127 at risk EG0021 affected127 at risk
Goitre	Endocrine disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Hypothyroidism	Endocrine disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Thyroid disorder	Endocrine disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Abnormal sensation in eye	Eye disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Altered visual depth perception	Eye disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Blepharospasm	Eye disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Diplopia	Eye disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Vision blurred	Eye disorders	MedDRA (v12.0)	Systematic Assessment	EG0003 affected367 at risk EG0018 affected127 at risk EG0023 affected127 at risk
Visual acuity reduced	Eye disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0012 affected127 at risk EG0022 affected127 at risk
Constipation	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0019 affected127 at risk EG0024 affected127 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0005 affected367 at risk EG0015 affected127 at risk EG0025 affected127 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0005 affected367 at risk EG00114 affected127 at risk EG0026 affected127 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Flatulence	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Gastritis	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0022 affected127 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Nausea	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0008 affected367 at risk EG00112 affected127 at risk EG0028 affected127 at risk
Toothache	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Vomiting	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0014 affected127 at risk EG0022 affected127 at risk
Asthenia	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Chest discomfort	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Chest pain	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0003 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Fatigue	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0004 affected367 at risk EG00115 affected127 at risk EG00210 affected127 at risk
Feeling abnormal	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Feeling drunk	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0015 affected127 at risk EG0020 affected127 at risk
Feeling hot	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Feeling jittery	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Gait disturbance	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Hunger	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Influenza like illness	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Irritatibility	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0022 affected127 at risk
Localised oedema	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Malaise	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Mucosal dryness	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Oedema peripheral	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0019 affected127 at risk EG0023 affected127 at risk
Pain	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0003 affected367 at risk EG0015 affected127 at risk EG0020 affected127 at risk
Thirst	General disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0022 affected127 at risk
Hypersensitivity	Immune system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Bronchitis	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Cystitis	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Gastroenteritis	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Herpes simplex	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Herpes zoster	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Infulenza	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0013 affected127 at risk EG0022 affected127 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Lung infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Nasopharyngitis	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0011 affected127 at risk EG0023 affected127 at risk
Pharyngitis	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Pneumonia	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Respiratory tract infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Schistomosomiasis cutaneous	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Sinusitis	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Skin infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Tooth infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0013 affected127 at risk EG0020 affected127 at risk
Urinary tract infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Viral infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0012 affected127 at risk EG0023 affected127 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Blood glucose increased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Blood pressure systolic increased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Blood triglycerides decreased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Blood triglycerides increased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0022 affected127 at risk
Creatinine renal clearance decreased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Drug screen positive	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Haemoglobin increased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Neutrophil count increased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Wieght increased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0015 affected127 at risk EG0022 affected127 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0012 affected127 at risk EG0023 affected127 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0013 affected127 at risk EG0022 affected127 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0011 affected127 at risk EG0022 affected127 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0022 affected127 at risk
Ataxia	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Balance disorder	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0014 affected127 at risk EG0020 affected127 at risk
Coordination abnormal	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Crying	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Disturbance in attention	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0019 affected127 at risk EG0024 affected127 at risk
Dizziness	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG00010 affected367 at risk EG00155 affected127 at risk EG00212 affected127 at risk
Dysaesthesia	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Dysarthria	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Dyskinesia	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Formication	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Head discomfort	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Headache	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG00014 affected367 at risk EG00115 affected127 at risk EG00214 affected127 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Memory impairment	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0014 affected127 at risk EG0023 affected127 at risk
Mental impairment	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Migraine	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Neuralgia	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0015 affected127 at risk EG0022 affected127 at risk
Paraesthesia	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0013 affected127 at risk EG0020 affected127 at risk
Sciatica	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Somnolence	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0003 affected367 at risk EG00120 affected127 at risk EG0028 affected127 at risk
Speech disorder	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Syncope	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Tension headache	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Tremor	Nervous system disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Abnormal dreams	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Agitation	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Anxiety	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Daydreaming	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Deja vu	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Depression	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Disinhibition	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Disorientation	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Dissociation	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Dyssomnia	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Emotional disorder	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Encopresis	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Euphoric	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Insomnia	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0026 affected127 at risk
Libido decreased	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Mood altered	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Morose	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Nervousness	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Nightmare	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Restlessness	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Sleep disorder	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0022 affected127 at risk
Tic	Psychiatric disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Haematuria	Renal and urinary disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Polyuria	Renal and urinary disorders	MedDRA (v12.0)	Systematic Assessment	EG0002 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Urinary retention	Renal and urinary disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Sexual dysfunction	Reproductive system and breast disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Dysponea	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0022 affected127 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Oropharyngeal	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0021 affected127 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0013 affected127 at risk EG0021 affected127 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0012 affected127 at risk EG0020 affected127 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0014 affected127 at risk EG0021 affected127 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0022 affected127 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0022 affected127 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0022 affected127 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Breast prothesis implantation	Surgical and medical procedures	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Hot flush	Vascular disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0020 affected127 at risk
Hypertension	Vascular disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0015 affected127 at risk EG0022 affected127 at risk
Hypotension	Vascular disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0022 affected127 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Blood calcium decreased	Investigations	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Adominal pain	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk

ID	Term
D009437	Neuralgia
D010149	Pain, Postoperative
D010591	Phantom Limb

ID	Term
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
D011183	Postoperative Complications
D010335	Pathologic Processes
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations

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

ID	Title	Description
BG000	Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).
BG001	Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)
EG000	Single-Blind Placebo	All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.	2	77
EG001	Double-Blind Pregabalin	Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7). At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).	4	109
EG002	Double-Blind Placebo	Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.	2	73

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (v12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Viral infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk
Muscle spasm	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Tremor	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Confusional state	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected367 at risk EG0011 affected127 at risk EG0020 affected127 at risk
Accidental Over Dose	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected367 at risk EG0010 affected127 at risk EG0021 affected127 at risk