Trial Outcomes & Findings for P4 (Pregabalin for Peripheral Posttraumatic Pain) (NCT NCT00292188)
NCT ID: NCT00292188
Last Updated: 2021-02-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
255 participants
Primary outcome timeframe
each day of Week 8
Results posted on
2021-02-09
Participant Flow
2-week screening period and single-blind washout and placebo run-in phase followed by a 4-week randomized, dose adjustment, double-blind treatment phase
Participant milestones
| Measure |
Single-Blind Placebo
All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
|
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).
|
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.
|
|---|---|---|---|
|
Single-Blind
STARTED
|
368
|
0
|
0
|
|
Single-Blind
Received Treatment
|
367
|
0
|
0
|
|
Single-Blind
COMPLETED
|
254
|
0
|
0
|
|
Single-Blind
NOT COMPLETED
|
114
|
0
|
0
|
|
Double-Blind
STARTED
|
0
|
127
|
127
|
|
Double-Blind
COMPLETED
|
0
|
96
|
98
|
|
Double-Blind
NOT COMPLETED
|
0
|
31
|
29
|
Reasons for withdrawal
| Measure |
Single-Blind Placebo
All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
|
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).
|
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.
|
|---|---|---|---|
|
Single-Blind
Adverse Event
|
14
|
0
|
0
|
|
Single-Blind
Lack of Efficacy
|
2
|
0
|
0
|
|
Single-Blind
Laboratory Abnormality
|
5
|
0
|
0
|
|
Single-Blind
Lost to Follow-up
|
3
|
0
|
0
|
|
Single-Blind
Other
|
77
|
0
|
0
|
|
Single-Blind
Withdrawal by Subject
|
12
|
0
|
0
|
|
Single-Blind
Did not receive treatment
|
1
|
0
|
0
|
|
Double-Blind
Adverse Event
|
0
|
25
|
9
|
|
Double-Blind
Lack of Efficacy
|
0
|
2
|
12
|
|
Double-Blind
Lost to Follow-up
|
0
|
1
|
0
|
|
Double-Blind
Other
|
0
|
3
|
4
|
|
Double-Blind
Withdrawal by Subject
|
0
|
0
|
3
|
|
Double-Blind
Laboratory Abnormality
|
0
|
0
|
1
|
Baseline Characteristics
P4 (Pregabalin for Peripheral Posttraumatic Pain)
Baseline characteristics by cohort
| Measure |
Pregabalin
n=127 Participants
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).
|
Placebo
n=127 Participants
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.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 years
|
38 participants
n=5 Participants
|
42 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
29 participants
n=5 Participants
|
25 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: each day of Week 8Population: Full Analysis Set (FAS): all randomized subjects who received \>= 1 dose study drug \& have post-randomization efficacy data. Last Observation Carried Forward (LOCF).
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=125 Participants
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.
|
|---|---|---|
|
Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
|
4.61 score on a scale
Standard Error 0.18
|
5.23 score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set (FAS), last observation carried forward (LOCF)
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
Outcome measures
| Measure |
Pregabalin
n=124 Participants
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).
|
Placebo
n=124 Participants
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.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Anxiety Score
|
6.52 score on scale
Standard Error 0.29
|
7.36 score on scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Week 8Population: FAS LOCF
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
Outcome measures
| Measure |
Pregabalin
n=124 Participants
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).
|
Placebo
n=124 Participants
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.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Depression Score
|
5.23 score on scale
Standard Error 0.24
|
6.20 score on scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Week 8Population: Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.
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.
Outcome measures
| Measure |
Pregabalin
n=32 Participants
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).
|
Placebo
n=41 Participants
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.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores
|
9.94 score on scale
Standard Error 0.77
|
11.63 score on scale
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Week 8Population: Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.
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
Outcome measures
| Measure |
Pregabalin
n=17 Participants
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).
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores
|
12.04 score on scale
Standard Error 0.79
|
11.80 score on scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline through Week 8Population: FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 5 (n=106, 104)
|
4.80 score on scale
Standard Error 0.16
|
5.26 score on scale
Standard Error 0.16
|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 6 (n=104, 101)
|
4.76 score on scale
Standard Error 0.16
|
5.34 score on scale
Standard Error 0.16
|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 1 (n=125, 125)
|
5.54 score on scale
Standard Error 0.11
|
5.79 score on scale
Standard Error 0.11
|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 2 (n=121, 119)
|
5.37 score on scale
Standard Error 0.13
|
5.64 score on scale
Standard Error 0.13
|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 3 (n=113, 116)
|
4.91 score on scale
Standard Error 0.15
|
5.44 score on scale
Standard Error 0.15
|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 4 (n=108, 108)
|
4.95 score on scale
Standard Error 0.15
|
5.27 score on scale
Standard Error 0.15
|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 7 (n=99, 99)
|
4.74 score on scale
Standard Error 0.18
|
5.26 score on scale
Standard Error 0.18
|
|
Weekly Mean Pain Score From Daily Pain Diary
Week 8 (n=97, 97)
|
4.64 score on scale
Standard Error 0.18
|
5.24 score on scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=125 Participants
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.
|
|---|---|---|
|
Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)
50% Responder
|
30 participants
|
18 participants
|
|
Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)
30% Responder
|
50 participants
|
32 participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS, LOCF
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=125 Participants
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.
|
|---|---|---|
|
Weekly Mean Sleep Interference Score
|
2.93 score on scale
Standard Error 0.17
|
3.73 score on scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Week 8Population: FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Medical Outcome Study (MOS) Sleep Subscales
Awaken Short of Breath/Headache (n= 118, 117)
|
14.71 score on a scale
Standard Error 2.14
|
20.66 score on a scale
Standard Error 2.13
|
|
Medical Outcome Study (MOS) Sleep Subscales
Sleep Quantity (n=117, 118)
|
6.39 score on a scale
Standard Error 0.32
|
6.48 score on a scale
Standard Error 0.32
|
|
Medical Outcome Study (MOS) Sleep Subscales
Sleep Disturbance (n=117, 118)
|
35.73 score on a scale
Standard Error 1.96
|
46.45 score on a scale
Standard Error 1.94
|
|
Medical Outcome Study (MOS) Sleep Subscales
Snoring (n=111, 118)
|
38.92 score on a scale
Standard Error 2.04
|
37.87 score on a scale
Standard Error 1.97
|
|
Medical Outcome Study (MOS) Sleep Subscales
Sleep Adequacy (n=119, 119)
|
55.25 score on a scale
Standard Error 2.44
|
44.61 score on a scale
Standard Error 2.43
|
|
Medical Outcome Study (MOS) Sleep Subscales
Somnolence (n=116, 114)
|
34.64 score on a scale
Standard Error 1.75
|
32.33 score on a scale
Standard Error 1.77
|
|
Medical Outcome Study (MOS) Sleep Subscales
Sleep Problems Index-6 (n=112, 111)
|
42.20 score on a scale
Standard Error 1.96
|
51.72 score on a scale
Standard Error 1.97
|
|
Medical Outcome Study (MOS) Sleep Subscales
Sleep problems Index-9 (n=111, 107)
|
35.43 score on a scale
Standard Error 1.49
|
42.98 score on a scale
Standard Error 1.52
|
SECONDARY outcome
Timeframe: Week 8Population: FAS, LOCF.
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.
Outcome measures
| Measure |
Pregabalin
n=117 Participants
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).
|
Placebo
n=119 Participants
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.
|
|---|---|---|
|
Medical Outcome Study (MOS) Optimal Sleep
|
58 participants
|
45 participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS, LOCF
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
very much improved
|
13 participants
|
6 participants
|
|
Patient Global Impression of Change (PGIC)
much improved
|
27 participants
|
22 participants
|
|
Patient Global Impression of Change (PGIC)
minimally improved
|
41 participants
|
26 participants
|
|
Patient Global Impression of Change (PGIC)
no change
|
30 participants
|
52 participants
|
|
Patient Global Impression of Change (PGIC)
minimally worse
|
3 participants
|
10 participants
|
|
Patient Global Impression of Change (PGIC)
much worse
|
3 participants
|
7 participants
|
|
Patient Global Impression of Change (PGIC)
very much worse
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS, LOCF
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC)
very much improved
|
11 participants
|
6 participants
|
|
Clinical Global Impression of Change (CGIC)
much improved
|
33 participants
|
18 participants
|
|
Clinical Global Impression of Change (CGIC)
minimally improved
|
36 participants
|
26 participants
|
|
Clinical Global Impression of Change (CGIC)
no change
|
33 participants
|
61 participants
|
|
Clinical Global Impression of Change (CGIC)
minimally worse
|
5 participants
|
9 participants
|
|
Clinical Global Impression of Change (CGIC)
much worse
|
4 participants
|
3 participants
|
|
Clinical Global Impression of Change (CGIC)
very much worse
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Screening, Week 8Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=127 Participants
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).
|
Placebo
n=127 Participants
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.
|
|---|---|---|
|
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
End of Treatment (Week 8) (n=122, 121)
|
52.64 score on a scale
Standard Deviation 31.87
|
42.56 score on a scale
Standard Deviation 32.52
|
|
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Screening (n=113, 113)
|
54.53 score on a scale
Standard Deviation 27.60
|
53.60 score on a scale
Standard Deviation 26.07
|
SECONDARY outcome
Timeframe: Screening, Week 8Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=122 Participants
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).
|
Placebo
n=121 Participants
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.
|
|---|---|---|
|
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Week 8 (n=122, 121)
|
62.36 score on scale
Standard Deviation 22.22
|
54.15 score on scale
Standard Deviation 22.78
|
|
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Screening (n=112, 110)
|
50.33 score on scale
Standard Deviation 20.85
|
51.05 score on scale
Standard Deviation 20.52
|
SECONDARY outcome
Timeframe: Screening, Week 8Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=127 Participants
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).
|
Placebo
n=127 Participants
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.
|
|---|---|---|
|
Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics
Screening (n=112, 110)
|
57.44 score on scale
Standard Deviation 21.84
|
59.39 score on scale
Standard Deviation 22.21
|
|
Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics
End of Treatment (Week 8) (n=122, 121)
|
71.52 score on scale
Standard Deviation 19.58
|
70.39 score on scale
Standard Deviation 21.00
|
SECONDARY outcome
Timeframe: Screening, Week 8Population: FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=127 Participants
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).
|
Placebo
n=127 Participants
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.
|
|---|---|---|
|
Pain Treatment Satisfaction Scale (PTSS): Efficacy
Screening (n=112, 110)
|
43.23 score on scale
Standard Deviation 24.06
|
42.73 score on scale
Standard Deviation 23.98
|
|
Pain Treatment Satisfaction Scale (PTSS): Efficacy
End of Treatment (Week 8) (n=122, 121)
|
53.21 score on scale
Standard Deviation 30.63
|
37.88 score on scale
Standard Deviation 32.61
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf)
pain interference index Baseline (n=125, 126)
|
4.57 score on a scale
Standard Deviation 2.11
|
4.69 score on a scale
Standard Deviation 2.36
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf)
pain interference index Week 8 (n=120, 121)
|
3.31 score on a scale
Standard Deviation 2.41
|
4.17 score on a scale
Standard Deviation 2.49
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf)
pain severity index Baseline (n= 122, 125)
|
5.36 score on a scale
Standard Deviation 1.71
|
5.72 score on a scale
Standard Deviation 2.04
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf)
pain severity index Week 8 (n=120, 120)
|
4.20 score on a scale
Standard Deviation 2.35
|
5.21 score on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score
|
33.29 percentage score on scale
Standard Error 1.68
|
37.12 percentage score on scale
Standard Error 1.66
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Baseline: None of the Time
|
48 participants
|
43 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Baseline: All of the Time
|
5 participants
|
1 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Week 8: All of the Time
|
3 participants
|
4 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Week 8: Most of the Time
|
10 participants
|
5 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Week 8: A Little of the Time
|
32 participants
|
30 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Week 8: None of the Time
|
41 participants
|
42 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Baseline: Most of the Time
|
6 participants
|
15 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Baseline: A Good Bit of the Time
|
5 participants
|
15 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Baseline: Some of the Time
|
20 participants
|
25 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Baseline: A Little of the Time
|
42 participants
|
27 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Week 8: A Good Bit of the Time
|
11 participants
|
13 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Week 8: Some of the Time
|
23 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Baseline: A Little of the Time
|
33 participants
|
26 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Baseline: All of the Time
|
4 participants
|
4 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Baseline: Most of the Time
|
8 participants
|
14 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Baseline: A Good Bit of the Time
|
13 participants
|
14 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Baseline: Some of the Time
|
27 participants
|
29 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Baseline: None of the Time
|
41 participants
|
39 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Week 8: All of the Time
|
3 participants
|
7 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Week 8: Most of the Time
|
12 participants
|
5 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Week 8: A Good Bit of the Time
|
14 participants
|
16 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Week 8: Some of the Time
|
26 participants
|
27 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Week 8: A Little of the Time
|
27 participants
|
33 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Week 8: None of the Time
|
38 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Week 8: All of the Time
|
1 particpants
|
3 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Week 8: Most of the Time
|
9 particpants
|
11 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Baseline: All of the Time
|
2 particpants
|
6 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Baseline: Most of the Time
|
8 particpants
|
12 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Baseline: A Good Bit of the Time
|
6 particpants
|
7 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Baseline: Some of the Time
|
22 particpants
|
15 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Baseline: A Little of the Time
|
23 particpants
|
35 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Baseline: None of the Time
|
64 particpants
|
51 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Week 8: A Good Bit of the Time
|
9 particpants
|
6 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Week 8: Some of the Time
|
26 particpants
|
23 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Week 8: A Little of the Time
|
22 particpants
|
27 particpants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Week 8: None of the Time
|
52 particpants
|
51 particpants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Baseline: All of the Time
|
7 participants
|
10 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Baseline: Most of the Time
|
7 participants
|
14 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Baseline: A Good Bit of the Time
|
6 participants
|
8 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Baseline: Some of the Time
|
40 participants
|
23 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Baseline: A Little of the Time
|
30 participants
|
33 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Baseline: None of the Time
|
36 participants
|
38 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Week 8: All of the Time
|
3 participants
|
9 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Week 8: Most of the Time
|
11 participants
|
7 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Week 8: A Good Bit of Time
|
13 participants
|
11 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Week 8: Some of the Time
|
28 participants
|
31 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Week 8: A Little of the Time
|
36 participants
|
35 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Week 8: None of the Time
|
29 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Baseline: Most of the Time
|
3 participants
|
16 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Baseline: A Little of the Time
|
39 participants
|
23 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Week 8: Most of the Time
|
10 participants
|
7 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Week 8: A Good Bit of Time
|
8 participants
|
13 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Baseline: All of the Time
|
5 participants
|
3 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Baseline: A Good Bit of Time
|
13 participants
|
14 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Baseline: Some of the Time
|
24 participants
|
23 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Baseline: None of the Time
|
42 participants
|
47 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Week 8: All of the Time
|
4 participants
|
5 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Week 8: Some of the Time
|
22 participants
|
26 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Week 8: A Little of the Time
|
34 participants
|
34 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Week 8: None of the Time
|
42 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Baseline: All of the Time
|
2 participants
|
1 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Baseline: Most of the Time
|
6 participants
|
9 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Baseline: None of the Time
|
51 participants
|
45 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Week 8: A Good Bit of Time
|
12 participants
|
6 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Week 8: Some of the Time
|
28 participants
|
22 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Baseline: A Good Bit of Time
|
3 participants
|
6 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Baseline: Some of the Time
|
31 participants
|
27 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Baseline: A Little of the Time
|
33 participants
|
36 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Week 8: All of the Time
|
4 participants
|
6 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Week 8: Most of the Time
|
6 participants
|
9 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Week 8: A Little of the Time
|
31 participants
|
31 participants
|
|
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Week 8: None of the Time
|
39 participants
|
47 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Davidson Trauma Scale (DTS): Severity
Week 8 (n=112, 113)
|
11.71 score on a scale
Standard Deviation 13.77
|
15.43 score on a scale
Standard Deviation 16.91
|
|
Davidson Trauma Scale (DTS): Severity
Baseline (n=116, 118)
|
15.55 score on a scale
Standard Deviation 14.16
|
17.83 score on a scale
Standard Deviation 16.94
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Davidson Trauma Scale (DTS): Frequency
Week 8 (n=118, 120)
|
14.16 score on scale
Standard Deviation 12.67
|
18.47 score on scale
Standard Deviation 15.51
|
|
Davidson Trauma Scale (DTS): Frequency
Baseline (n=124, 124)
|
18.27 score on scale
Standard Deviation 13.98
|
20.90 score on scale
Standard Deviation 15.11
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
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.
Outcome measures
| Measure |
Pregabalin
n=126 Participants
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).
|
Placebo
n=126 Participants
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.
|
|---|---|---|
|
Davidson Trauma Scale (DTS): Total Score
Baseline (n=116, 118)
|
34.57 score on scale
Standard Deviation 27.56
|
38.76 score on scale
Standard Deviation 31.55
|
|
Davidson Trauma Scale (DTS): Total Score
Week 8 (n=112, 113)
|
26.18 score on scale
Standard Deviation 26.09
|
33.62 score on scale
Standard Deviation 31.65
|
Adverse Events
Single-Blind Placebo
Serious events: 2 serious events
Other events: 77 other events
Deaths: 0 deaths
Double-Blind Pregabalin
Serious events: 4 serious events
Other events: 109 other events
Deaths: 0 deaths
Double-Blind Placebo
Serious events: 2 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-Blind Placebo
All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
|
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).
|
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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Infections and infestations
Viral infection
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Tremor
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Accidental Over Dose
|
0.27%
1/367
|
0.00%
0/127
|
0.79%
1/127
|
Other adverse events
| Measure |
Single-Blind Placebo
All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
|
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).
|
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Investigations
Blood calcium increased
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Cardiac disorders
Palpitations
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/367
|
3.1%
4/127
|
0.79%
1/127
|
|
Endocrine disorders
Goitre
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Eye disorders
Altered visual depth perception
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Eye disorders
Blepharospasm
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Eye disorders
Diplopia
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Eye disorders
Vision blurred
|
0.82%
3/367
|
6.3%
8/127
|
2.4%
3/127
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.27%
1/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.27%
1/367
|
1.6%
2/127
|
1.6%
2/127
|
|
Gastrointestinal disorders
Constipation
|
0.27%
1/367
|
7.1%
9/127
|
3.1%
4/127
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
5/367
|
3.9%
5/127
|
3.9%
5/127
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
5/367
|
11.0%
14/127
|
4.7%
6/127
|
|
Gastrointestinal disorders
Dyspepsia
|
0.54%
2/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Gastrointestinal disorders
Flatulence
|
0.27%
1/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/367
|
0.00%
0/127
|
1.6%
2/127
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Gastrointestinal disorders
Nausea
|
2.2%
8/367
|
9.4%
12/127
|
6.3%
8/127
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Gastrointestinal disorders
Vomiting
|
0.27%
1/367
|
3.1%
4/127
|
1.6%
2/127
|
|
General disorders
Asthenia
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
General disorders
Chest discomfort
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
General disorders
Chest pain
|
0.82%
3/367
|
0.00%
0/127
|
0.00%
0/127
|
|
General disorders
Fatigue
|
1.1%
4/367
|
11.8%
15/127
|
7.9%
10/127
|
|
General disorders
Feeling abnormal
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
General disorders
Feeling drunk
|
0.00%
0/367
|
3.9%
5/127
|
0.00%
0/127
|
|
General disorders
Feeling hot
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
General disorders
Feeling jittery
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
General disorders
Gait disturbance
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
General disorders
Hunger
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
General disorders
Influenza like illness
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
General disorders
Irritatibility
|
0.00%
0/367
|
0.00%
0/127
|
1.6%
2/127
|
|
General disorders
Localised oedema
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
General disorders
Malaise
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
General disorders
Mucosal dryness
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
General disorders
Oedema peripheral
|
0.27%
1/367
|
7.1%
9/127
|
2.4%
3/127
|
|
General disorders
Pain
|
0.82%
3/367
|
3.9%
5/127
|
0.00%
0/127
|
|
General disorders
Thirst
|
0.00%
0/367
|
1.6%
2/127
|
1.6%
2/127
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Infections and infestations
Bronchitis
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Infections and infestations
Cystitis
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Infections and infestations
Herpes simplex
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Infections and infestations
Infulenza
|
0.54%
2/367
|
2.4%
3/127
|
1.6%
2/127
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Infections and infestations
Lung infection
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Infections and infestations
Nasopharyngitis
|
0.54%
2/367
|
0.79%
1/127
|
2.4%
3/127
|
|
Infections and infestations
Pharyngitis
|
0.27%
1/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Infections and infestations
Pneumonia
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Infections and infestations
Schistomosomiasis cutaneous
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Infections and infestations
Sinusitis
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Infections and infestations
Skin infection
|
0.27%
1/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Infections and infestations
Tooth infection
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/367
|
2.4%
3/127
|
0.00%
0/127
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Infections and infestations
Viral infection
|
0.27%
1/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Injury, poisoning and procedural complications
Fall
|
0.27%
1/367
|
1.6%
2/127
|
2.4%
3/127
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Investigations
Blood glucose increased
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Investigations
Blood triglycerides decreased
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/367
|
0.00%
0/127
|
1.6%
2/127
|
|
Investigations
Creatinine renal clearance decreased
|
0.54%
2/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Investigations
Drug screen positive
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Investigations
Haemoglobin increased
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Investigations
Neutrophil count increased
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Investigations
Wieght increased
|
0.27%
1/367
|
3.9%
5/127
|
1.6%
2/127
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.54%
2/367
|
1.6%
2/127
|
2.4%
3/127
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.27%
1/367
|
2.4%
3/127
|
1.6%
2/127
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.54%
2/367
|
0.79%
1/127
|
1.6%
2/127
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.27%
1/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.27%
1/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.27%
1/367
|
0.79%
1/127
|
1.6%
2/127
|
|
Nervous system disorders
Ataxia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/367
|
3.1%
4/127
|
0.00%
0/127
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Crying
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Nervous system disorders
Disturbance in attention
|
0.27%
1/367
|
7.1%
9/127
|
3.1%
4/127
|
|
Nervous system disorders
Dizziness
|
2.7%
10/367
|
43.3%
55/127
|
9.4%
12/127
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Formication
|
0.27%
1/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Nervous system disorders
Head discomfort
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Headache
|
3.8%
14/367
|
11.8%
15/127
|
11.0%
14/127
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/367
|
3.1%
4/127
|
2.4%
3/127
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Nervous system disorders
Migraine
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Neuralgia
|
0.27%
1/367
|
3.9%
5/127
|
1.6%
2/127
|
|
Nervous system disorders
Paraesthesia
|
0.54%
2/367
|
2.4%
3/127
|
0.00%
0/127
|
|
Nervous system disorders
Sciatica
|
0.27%
1/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Nervous system disorders
Somnolence
|
0.82%
3/367
|
15.7%
20/127
|
6.3%
8/127
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Syncope
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Nervous system disorders
Tension headache
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Nervous system disorders
Tremor
|
0.00%
0/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Psychiatric disorders
Agitation
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Deja vu
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Depression
|
0.54%
2/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Dyssomnia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Psychiatric disorders
Encopresis
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Euphoric
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Insomnia
|
0.27%
1/367
|
0.79%
1/127
|
4.7%
6/127
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Morose
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/367
|
0.00%
0/127
|
1.6%
2/127
|
|
Psychiatric disorders
Tic
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Renal and urinary disorders
Polyuria
|
0.54%
2/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Respiratory, thoracic and mediastinal disorders
Dysponea
|
0.00%
0/367
|
0.79%
1/127
|
1.6%
2/127
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal
|
0.00%
0/367
|
0.79%
1/127
|
0.79%
1/127
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/367
|
2.4%
3/127
|
0.79%
1/127
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/367
|
1.6%
2/127
|
0.00%
0/127
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/367
|
3.1%
4/127
|
0.79%
1/127
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.27%
1/367
|
0.00%
0/127
|
1.6%
2/127
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/367
|
0.79%
1/127
|
1.6%
2/127
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/367
|
0.00%
0/127
|
1.6%
2/127
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Surgical and medical procedures
Breast prothesis implantation
|
0.00%
0/367
|
0.00%
0/127
|
0.79%
1/127
|
|
Vascular disorders
Hot flush
|
0.27%
1/367
|
0.00%
0/127
|
0.00%
0/127
|
|
Vascular disorders
Hypertension
|
0.27%
1/367
|
3.9%
5/127
|
1.6%
2/127
|
|
Vascular disorders
Hypotension
|
0.27%
1/367
|
0.79%
1/127
|
1.6%
2/127
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Investigations
Blood calcium decreased
|
0.00%
0/367
|
0.79%
1/127
|
0.00%
0/127
|
|
Gastrointestinal disorders
Adominal pain
|
0.27%
1/367
|
0.79%
1/127
|
0.00%
0/127
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER