Trial Outcomes & Findings for Lyrica (Pregabalin) Korean Post Marketing Surveillance Study (NCT NCT01220180)
NCT ID: NCT01220180
Last Updated: 2021-01-25
Results Overview
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.
Recruitment status
COMPLETED
Target enrollment
4175 participants
Primary outcome timeframe
Baseline through Week 12
Results posted on
2021-01-25
Participant Flow
Participant milestones
| Measure |
Pregabalin
Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Overall Study
STARTED
|
4175
|
|
Overall Study
Treated
|
4174
|
|
Overall Study
COMPLETED
|
3968
|
|
Overall Study
NOT COMPLETED
|
207
|
Reasons for withdrawal
| Measure |
Pregabalin
Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
76
|
|
Overall Study
Other
|
72
|
|
Overall Study
Adverse Event
|
35
|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Death
|
1
|
|
Overall Study
Randomized but not treated
|
1
|
Baseline Characteristics
Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
Baseline characteristics by cohort
| Measure |
Pregabalin: Epilepsy
n=787 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
|
Pregabalin: Neuropathic Pain
n=3266 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
|
Pregabalin: Fibromyalgia
n=121 Participants
Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
|
Total
n=4174 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Less than 20 years
|
37 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Customized
20 to 29 years
|
192 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
221 Participants
n=4 Participants
|
|
Age, Customized
30 to 39 years
|
158 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Age, Customized
40 to 49 years
|
146 Participants
n=5 Participants
|
409 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
585 Participants
n=4 Participants
|
|
Age, Customized
50 to 59 years
|
119 Participants
n=5 Participants
|
840 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
995 Participants
n=4 Participants
|
|
Age, Customized
60 to 69 years
|
89 Participants
n=5 Participants
|
1094 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
1211 Participants
n=4 Participants
|
|
Age, Customized
Greater than and equal to 70 years
|
46 Participants
n=5 Participants
|
790 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
852 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
364 Participants
n=5 Participants
|
1689 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
2136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
423 Participants
n=5 Participants
|
1577 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
2038 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.
Outcome measures
| Measure |
Pregabalin
n=644 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population
|
66.30 Percentage of participants
Interval 62.65 to 69.96
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.
Outcome measures
| Measure |
Pregabalin
n=575 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population
|
67.13 Percentage of participants
Interval 63.29 to 70.97
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.
Outcome measures
| Measure |
Pregabalin
n=644 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
Greater than or equal to 75%
|
55.75 Percentage of participants
|
|
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
Greater than or equal to 50% to 74%
|
28.57 Percentage of participants
|
|
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
0% to 49%
|
14.13 Percentage of participants
|
|
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
Worsening
|
1.55 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.
Outcome measures
| Measure |
Pregabalin
n=575 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Percentage of Participants With Improvement in Seizure Frequency in PP Population
Worsening
|
0.87 Percentage of participants
|
|
Percentage of Participants With Improvement in Seizure Frequency in PP Population
Greater than or equal to 75%
|
57.22 Percentage of participants
|
|
Percentage of Participants With Improvement in Seizure Frequency in PP Population
Greater than or equal to 50% to 74%
|
29.39 Percentage of participants
|
|
Percentage of Participants With Improvement in Seizure Frequency in PP Population
0% to 49%
|
12.52 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Outcome measures
| Measure |
Pregabalin
n=3210 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6
Baseline
|
5.61 Units on a scale
Standard Deviation 1.77
|
|
Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6
Change at Week 6
|
-3.02 Units on a scale
Standard Deviation 1.79
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Outcome measures
| Measure |
Pregabalin
n=3087 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6
Baseline
|
5.58 Units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6
Change at Week 6
|
-3.02 Units on a scale
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Outcome measures
| Measure |
Pregabalin
n=120 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6
Baseline
|
6.69 Units on a scale
Standard Deviation 1.68
|
|
Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6
Change at Week 6
|
-3.37 Units on a scale
Standard Deviation 1.74
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Outcome measures
| Measure |
Pregabalin
n=117 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6
Baseline
|
6.69 Units on a scale
Standard Deviation 1.69
|
|
Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6
Change at Week 6
|
-3.37 Units on a scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Outcome measures
| Measure |
Pregabalin
n=3210 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6
Baseline
|
4.25 Units on a scale
Standard Deviation 2.23
|
|
Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6
Change at Week 6
|
-2.38 Units on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Outcome measures
| Measure |
Pregabalin
n=3087 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6
Baseline
|
4.23 Units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6
Change at Week 6
|
-2.37 Units on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Outcome measures
| Measure |
Pregabalin
n=120 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6
Baseline
|
6.43 Units on a scale
Standard Deviation 1.80
|
|
Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6
Change at Week 6
|
-3.19 Units on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Outcome measures
| Measure |
Pregabalin
n=117 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6
Baseline
|
6.41 Units on a scale
Standard Deviation 1.81
|
|
Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6
Change at Week 6
|
-3.24 Units on a scale
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=3210 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
Very much improved
|
968 Participants
|
|
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
Much improved
|
1313 Participants
|
|
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
A little improved
|
671 Participants
|
|
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
No change
|
141 Participants
|
|
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
A little worse
|
7 Participants
|
|
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
Much worse
|
5 Participants
|
|
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=3087 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With CGIC Scale for NeP in PP Population
Very much improved
|
956 Participants
|
|
Number of Participants With CGIC Scale for NeP in PP Population
Much Improved
|
1306 Participants
|
|
Number of Participants With CGIC Scale for NeP in PP Population
A little improved
|
664 Participants
|
|
Number of Participants With CGIC Scale for NeP in PP Population
No change
|
140 Participants
|
|
Number of Participants With CGIC Scale for NeP in PP Population
A little worse
|
7 Participants
|
|
Number of Participants With CGIC Scale for NeP in PP Population
Much worse
|
5 Participants
|
|
Number of Participants With CGIC Scale for NeP in PP Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=3210 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
Very much improved
|
1027 Participants
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
Much improved
|
1187 Participants
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
A little improved
|
686 Participants
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
No change
|
195 Participants
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
A little worse
|
5 Participants
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
Much worse
|
3 Participants
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=3087 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With PGIC Scale for NeP in PP Population
Very much improved
|
1018 Participants
|
|
Number of Participants With PGIC Scale for NeP in PP Population
Much Improved
|
1177 Participants
|
|
Number of Participants With PGIC Scale for NeP in PP Population
A little improved
|
680 Participants
|
|
Number of Participants With PGIC Scale for NeP in PP Population
No change
|
193 Participants
|
|
Number of Participants With PGIC Scale for NeP in PP Population
A little worse
|
5 Participants
|
|
Number of Participants With PGIC Scale for NeP in PP Population
Much worse
|
3 Participants
|
|
Number of Participants With PGIC Scale for NeP in PP Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=120 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
Very much improved
|
30 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
Much improved
|
62 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
A little improved
|
21 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
No change
|
5 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
A little worse
|
0 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
Much worse
|
0 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=117 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
Very much improved
|
29 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
Much Improved
|
62 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
A little improved
|
21 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
No change
|
5 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
A little worse
|
0 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
Much worse
|
0 Participants
|
|
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=120 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
Very much improved
|
35 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
Much improved
|
61 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
A little improved
|
14 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
No change
|
8 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
A little worse
|
0 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
Much worse
|
0 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Outcome measures
| Measure |
Pregabalin
n=117 Participants
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
Very much improved
|
34 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
Much Improved
|
61 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
A little improved
|
14 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
No change
|
8 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
A little worse
|
0 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
Much worse
|
0 Participants
|
|
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
Very much worse
|
0 Participants
|
Adverse Events
Pregabalin
Serious events: 2 serious events
Other events: 190 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=4174 participants at risk
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/4174
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
Pneumonia
|
0.02%
1/4174
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.02%
1/4174
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=4174 participants at risk
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.02%
1/4174
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
|
0.17%
7/4174
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
|
0.05%
2/4174
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
|
0.05%
2/4174
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
|
0.05%
2/4174
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
|
0.02%
1/4174
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
|
0.50%
21/4174
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
Gastritis
|
0.02%
1/4174
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
Gastrointestinal disorder
|
0.02%
1/4174
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
Haematochezia
|
0.02%
1/4174
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
|
0.17%
7/4174
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
Asthenia
|
0.05%
2/4174
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
Chest pain
|
0.05%
2/4174
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
Face oedema
|
0.07%
3/4174
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
|
0.07%
3/4174
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
Gait disturbance
|
0.02%
1/4174
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
|
0.31%
13/4174
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
|
0.12%
5/4174
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
Pulmonary tuberculosis
|
0.05%
2/4174
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
Blood creatinine increased
|
0.02%
1/4174
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
Blood glucose decreased
|
0.02%
1/4174
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
Blood pressure increased
|
0.02%
1/4174
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
|
0.02%
1/4174
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
Gout
|
0.02%
1/4174
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
|
0.05%
2/4174
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
|
0.02%
1/4174
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
Rheumatoid arthritis
|
0.02%
1/4174
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
|
0.05%
2/4174
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
Cerebral infarction
|
0.02%
1/4174
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
Convulsion
|
0.10%
4/4174
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
|
0.02%
1/4174
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
|
1.8%
74/4174
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
|
0.02%
1/4174
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
Loss of consciousness
|
0.02%
1/4174
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
Memory impairment
|
0.02%
1/4174
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
|
0.02%
1/4174
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
|
1.7%
69/4174
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
Speech disorder
|
0.02%
1/4174
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
Tremor
|
0.10%
4/4174
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
|
0.02%
1/4174
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
Libido decreased
|
0.05%
2/4174
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
Sleep disorder
|
0.02%
1/4174
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.
|
|
Renal and urinary disorders
Dysuria
|
0.02%
1/4174
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.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.02%
1/4174
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
|
0.05%
2/4174
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
Skin disorder
|
0.02%
1/4174
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