Trial Outcomes & Findings for Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain (NCT NCT01117766)
NCT ID: NCT01117766
Last Updated: 2019-04-23
Results Overview
Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Results posted on
2019-04-23
Participant Flow
Participant milestones
| Measure |
Pregabalin Then Placebo
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
|
Placebo Then Pregabalin
Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
|---|---|---|
|
First Intervention
STARTED
|
14
|
17
|
|
First Intervention
Received Treatment
|
14
|
17
|
|
First Intervention
COMPLETED
|
13
|
16
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Washout Period
STARTED
|
13
|
16
|
|
Washout Period
COMPLETED
|
13
|
14
|
|
Washout Period
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
13
|
14
|
|
Second Intervention
COMPLETED
|
11
|
9
|
|
Second Intervention
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Pregabalin Then Placebo
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
|
Placebo Then Pregabalin
Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
|
First Intervention
Protocol Violation
|
1
|
0
|
|
Washout Period
Protocol Violation
|
0
|
2
|
|
Second Intervention
Lost to Follow-up
|
1
|
0
|
|
Second Intervention
Other
|
1
|
2
|
|
Second Intervention
Adverse Event
|
0
|
2
|
|
Second Intervention
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
Baseline characteristics by cohort
| Measure |
All Participants
n=31 Participants
Includes all participants randomized to receive pregabalin first and placebo first.
|
|---|---|
|
Age, Customized
18 to 44 years
|
9 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
12 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
10 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: Full analysis set (FAS)=participants with present pain intensity score \>=4 out of 10 for brush evoked allodynia at screening and randomization, \>=4 out of 7 non missing values in week prior to randomization, \>4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean.
Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (n=15,16)
|
-1.09 scores on a scale
Standard Deviation 1.735
|
-1.16 scores on a scale
Standard Deviation 1.730
|
|
Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (n=18,21)
|
-1.31 scores on a scale
Standard Deviation 1.924
|
-0.67 scores on a scale
Standard Deviation 1.984
|
PRIMARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean.
Dynamic area brush in cm\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \* perpendicular height); Σ ( ½ ri \* sin(45) r(i+1) ) = Σ ( (ri \* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (n=16,17)
|
-53.441 cm2
Standard Deviation 114.7084
|
-49.180 cm2
Standard Deviation 94.3329
|
|
Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (n=17,20)
|
-49.808 cm2
Standard Deviation 100.2094
|
-18.921 cm2
Standard Deviation 104.3942
|
PRIMARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.
Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (Size 8, n=15,16)
|
-0.133 scores on a scale
Standard Deviation 1.7494
|
0.417 scores on a scale
Standard Deviation 2.6063
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (Size 16, n=15,16)
|
-1.356 scores on a scale
Standard Deviation 2.4800
|
0.208 scores on a scale
Standard Deviation 2.6412
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (Size 32, n=15,16)
|
-0.200 scores on a scale
Standard Deviation 1.8551
|
-0.188 scores on a scale
Standard Deviation 2.1636
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (Size 64, n=15,16)
|
-1.128 scores on a scale
Standard Deviation 2.0304
|
0.561 scores on a scale
Standard Deviation 2.9543
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (Size 128, n=15,16)
|
-1.267 scores on a scale
Standard Deviation 1.6868
|
-0.097 scores on a scale
Standard Deviation 1.3385
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (Size 256, n=15,16)
|
-0.773 scores on a scale
Standard Deviation 2.2420
|
-0.171 scores on a scale
Standard Deviation 1.4133
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (Size 512, n=15,16)
|
-1.533 scores on a scale
Standard Deviation 1.7873
|
-0.480 scores on a scale
Standard Deviation 1.1183
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (Size 8, n=18,21)
|
-0.370 scores on a scale
Standard Deviation 1.2674
|
-0.429 scores on a scale
Standard Deviation 1.7132
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (Size 16, n=18,21)
|
-0.611 scores on a scale
Standard Deviation 1.2693
|
-0.889 scores on a scale
Standard Deviation 2.2616
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (Size 32, n=18,21)
|
-0.333 scores on a scale
Standard Deviation 1.4597
|
-0.825 scores on a scale
Standard Deviation 2.1386
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (Size 64, n=18,21)
|
-1.116 scores on a scale
Standard Deviation 1.6152
|
-0.462 scores on a scale
Standard Deviation 3.1381
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (Size 128, n=18,21)
|
-1.315 scores on a scale
Standard Deviation 1.9322
|
-0.841 scores on a scale
Standard Deviation 2.2843
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (Size 256, n=18,21)
|
-1.322 scores on a scale
Standard Deviation 1.8729
|
-0.751 scores on a scale
Standard Deviation 2.5072
|
|
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (Size 512, n=18,21)
|
-1.836 scores on a scale
Standard Deviation 1.7249
|
-0.420 scores on a scale
Standard Deviation 2.0238
|
PRIMARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean.
Punctate allodynia area in cm\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \* perpendicular height); Σ ( ½ ri \* sin(45) r(i+1) ) = Σ ( (ri \* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (n=16,17)
|
-75.571 cm2
Standard Deviation 148.8301
|
-3.232 cm2
Standard Deviation 125.8041
|
|
Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (n=17,20)
|
-75.834 cm2
Standard Deviation 133.9530
|
-4.130 cm2
Standard Deviation 129.8261
|
PRIMARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (5 degrees, n=15,16)
|
-0.821 scores on a scale
Standard Deviation 1.2039
|
-1.402 scores on a scale
Standard Deviation 3.0295
|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (10 degrees, n=15,16)
|
-0.333 scores on a scale
Standard Deviation 1.3318
|
-1.313 scores on a scale
Standard Deviation 2.0402
|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (15 degrees, n=15,16)
|
-0.567 scores on a scale
Standard Deviation 2.3442
|
0.125 scores on a scale
Standard Deviation 1.3478
|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (20 degrees, n=15,16)
|
-0.500 scores on a scale
Standard Deviation 1.9365
|
0.031 scores on a scale
Standard Deviation 1.4314
|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (5 degrees, n=18,21)
|
-0.726 scores on a scale
Standard Deviation 1.3375
|
-0.703 scores on a scale
Standard Deviation 2.4746
|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (10 degrees, n=18,21)
|
-0.278 scores on a scale
Standard Deviation 1.3086
|
-0.810 scores on a scale
Standard Deviation 1.6239
|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (15 degrees, n=18,21)
|
-0.583 scores on a scale
Standard Deviation 1.2632
|
0.095 scores on a scale
Standard Deviation 1.5622
|
|
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (20 degrees, n=18,21)
|
-0.111 scores on a scale
Standard Deviation 1.4507
|
-0.333 scores on a scale
Standard Deviation 0.7130
|
PRIMARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (47 degrees, n=18,21)
|
-0.337 scores on a scale
Standard Deviation 3.0065
|
-0.083 scores on a scale
Standard Deviation 2.7679
|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (40 degrees, n=15,16)
|
-1.100 scores on a scale
Standard Deviation 2.2216
|
-0.625 scores on a scale
Standard Deviation 2.3130
|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (44 degrees, n=15,16)
|
0.400 scores on a scale
Standard Deviation 3.4959
|
-0.938 scores on a scale
Standard Deviation 2.8395
|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (47 degrees, n=15,16)
|
-0.908 scores on a scale
Standard Deviation 2.5249
|
-0.578 scores on a scale
Standard Deviation 3.3112
|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (50 degrees, n=15,16)
|
-1.385 scores on a scale
Standard Deviation 2.8981
|
-0.865 scores on a scale
Standard Deviation 2.1050
|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (40 degrees, n=18,21)
|
-0.639 scores on a scale
Standard Deviation 2.5771
|
-0.143 scores on a scale
Standard Deviation 0.9506
|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (44 degrees, n=18,21)
|
-0.444 scores on a scale
Standard Deviation 4.1084
|
-0.495 scores on a scale
Standard Deviation 2.9959
|
|
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (50 degrees, n=18,21)
|
-0.566 scores on a scale
Standard Deviation 2.2423
|
-0.387 scores on a scale
Standard Deviation 2.6689
|
SECONDARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF).
Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (\>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (n=19,18)
|
-1.456 scores on a scale
Standard Deviation 1.8287
|
-0.484 scores on a scale
Standard Deviation 2.0721
|
|
Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (n=18,18)
|
-1.397 scores on a scale
Standard Deviation 1.4823
|
-0.769 scores on a scale
Standard Deviation 1.4778
|
SECONDARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean.
PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (n=18,21)
|
2.4 scores on a scale
Standard Deviation 1.20
|
3.8 scores on a scale
Standard Deviation 1.63
|
|
Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (n=15,16)
|
3.3 scores on a scale
Standard Deviation 1.87
|
3.4 scores on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=number of participants contributing to the mean.
Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?"
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7
Week 3 (Visits 3 and 6) (n=7,10)
|
-1.5 scores on a scale
Standard Deviation 2.39
|
-0.4 scores on a scale
Standard Deviation 2.66
|
|
Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7
Week 4 (Visits 4 and 7) (n=11,11)
|
-1.6 scores on a scale
Standard Deviation 1.95
|
0.0 scores on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Week 4 (Visits 4 and 7) of each periodPopulation: FAS. n=18, 18; number of participants contributing to the mean.
NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.
Outcome measures
| Measure |
Pregabalin
n=21 Participants
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=22 Participants
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7
|
-10.67 scores on a scale
Standard Deviation 21.404
|
-7.72 scores on a scale
Standard Deviation 19.384
|
Adverse Events
Pregabalin
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=28 participants at risk
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=30 participants at risk
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Reproductive system and breast disorders
Menopause and related conditions
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Pregabalin
n=28 participants at risk
During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
|
Placebo
n=30 participants at risk
Participants took placebo to match the pregabalin doses BID.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
10.7%
3/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Diplopia
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
7.1%
2/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Change of bowel habit
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
2/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
4/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tongue coated
|
7.1%
2/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
21.4%
6/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
7.1%
2/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Eye infection
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
7.1%
2/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
7.1%
2/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
10.7%
3/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Ataxia
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
14.3%
4/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
25.0%
7/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Poor quality sleep
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Agitation
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Bradyphrenia
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Euphoric mood
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Withdrawal syndrome
|
7.1%
2/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hypnagogic hallucination
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Phlebitis
|
3.6%
1/28
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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