Epilepsy, Fibromyalgia, Neuropathic Pain, Post-market Surveillance
Conditions
Keywords
epilepsy, neuropathic pain, fibromyalgia, post-market surveillance, prospective observational
Brief summary
This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.
Detailed description
continuous patients with target disorders in collaborating institutions
Interventions
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration
Exclusion criteria
* Non-consenting * Hypersensitivity to the active substance or to any of the excipients * galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population | Baseline through Week 12 | 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. |
| Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population | Baseline through Week 12 | 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. |
| Percentage of Participants With Improvement in Seizure Frequency in ITT Population | Baseline through Week 12 | 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. |
| Percentage of Participants With Improvement in Seizure Frequency in PP Population | Baseline through Week 12 | 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. |
| Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6 | Baseline and Week 6 | 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. |
| Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6 | Baseline and Week 6 | 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. |
| Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6 | Baseline and Week 6 | 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. |
| Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6 | Baseline and Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | Week 6 | 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. |
| Number of Participants With CGIC Scale for Fibromyalgia in PP Population | Week 6 | 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. |
| Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6 | Baseline and Week 6 | 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. |
| Number of Participants With PGIC Scale for Fibromyalgia in PP Population | Week 6 | 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. |
| Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | Week 6 | 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. |
| Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6 | Baseline and Week 6 | 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. |
| Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6 | Baseline and Week 6 | 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. |
| Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6 | Baseline and Week 6 | 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. |
| Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | Week 6 | 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. |
| Number of Participants With CGIC Scale for NeP in PP Population | Week 6 | 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. |
| Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | Week 6 | 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. |
| Number of Participants With PGIC Scale for NeP in PP Population | Week 6 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin: Epilepsy 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. | 787 |
| Pregabalin: Neuropathic Pain 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). | 3,266 |
| Pregabalin: Fibromyalgia Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia. | 121 |
| Total | 4,174 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 35 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 22 |
| Overall Study | Lost to Follow-up | 76 |
| Overall Study | Other | 72 |
| Overall Study | Randomized but not treated | 1 |
Baseline characteristics
| Characteristic | Total | Pregabalin: Epilepsy | Pregabalin: Neuropathic Pain | Pregabalin: Fibromyalgia |
|---|---|---|---|---|
| Age, Customized 20 to 29 years | 221 Participants | 192 Participants | 26 Participants | 3 Participants |
| Age, Customized 30 to 39 years | 271 Participants | 158 Participants | 105 Participants | 8 Participants |
| Age, Customized 40 to 49 years | 585 Participants | 146 Participants | 409 Participants | 30 Participants |
| Age, Customized 50 to 59 years | 995 Participants | 119 Participants | 840 Participants | 36 Participants |
| Age, Customized 60 to 69 years | 1211 Participants | 89 Participants | 1094 Participants | 28 Participants |
| Age, Customized Greater than and equal to 70 years | 852 Participants | 46 Participants | 790 Participants | 16 Participants |
| Age, Customized Less than 20 years | 39 Participants | 37 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 2136 Participants | 364 Participants | 1689 Participants | 83 Participants |
| Sex: Female, Male Male | 2038 Participants | 423 Participants | 1577 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 190 / 4,174 |
| serious Total, serious adverse events | 2 / 4,174 |
Outcome results
Primary
Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6
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.
Time frame: Baseline and Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Primary
Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6
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.
Time frame: Baseline and Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Primary
Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6
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.
Time frame: Baseline and Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Primary
Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6
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.
Time frame: Baseline and Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Primary
Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population
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.
Time frame: Baseline through Week 12
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population | 66.30 Percentage of participants |
Primary
Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population
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.
Time frame: Baseline through Week 12
Population: PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population | 67.13 Percentage of participants |
Primary
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
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.
Time frame: Baseline through Week 12
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in ITT Population | Greater than or equal to 75% | 55.75 Percentage of participants |
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in ITT Population | Greater than or equal to 50% to 74% | 28.57 Percentage of participants |
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in ITT Population | 0% to 49% | 14.13 Percentage of participants |
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in ITT Population | Worsening | 1.55 Percentage of participants |
Primary
Percentage of Participants With Improvement in Seizure Frequency in PP Population
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.
Time frame: Baseline through Week 12
Population: PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in PP Population | Greater than or equal to 75% | 57.22 Percentage of participants |
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in PP Population | Greater than or equal to 50% to 74% | 29.39 Percentage of participants |
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in PP Population | 0% to 49% | 12.52 Percentage of participants |
| Pregabalin | Percentage of Participants With Improvement in Seizure Frequency in PP Population | Worsening | 0.87 Percentage of participants |
Secondary
Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6
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.
Time frame: Baseline and Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6 | Baseline | 6.43 Units on a scale | Standard Deviation 1.8 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6
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.
Time frame: Baseline and Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6
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.
Time frame: Baseline and Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6
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.
Time frame: Baseline and Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
p-value: <0.0001t-test, 2 sided
Secondary
Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
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.
Time frame: Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | Very much improved | 30 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | Much improved | 62 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | A little improved | 21 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | No change | 5 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | A little worse | 0 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | Much worse | 0 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | Very much worse | 0 Participants |
Secondary
Number of Participants With CGIC Scale for Fibromyalgia in PP Population
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.
Time frame: Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | Very much improved | 29 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | Much Improved | 62 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | A little improved | 21 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | No change | 5 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | A little worse | 0 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | Much worse | 0 Participants |
| Pregabalin | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | Very much worse | 0 Participants |
Secondary
Number of Participants With CGIC Scale for NeP in PP Population
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.
Time frame: Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With CGIC Scale for NeP in PP Population | Very much improved | 956 Participants |
| Pregabalin | Number of Participants With CGIC Scale for NeP in PP Population | Much Improved | 1306 Participants |
| Pregabalin | Number of Participants With CGIC Scale for NeP in PP Population | A little improved | 664 Participants |
| Pregabalin | Number of Participants With CGIC Scale for NeP in PP Population | No change | 140 Participants |
| Pregabalin | Number of Participants With CGIC Scale for NeP in PP Population | A little worse | 7 Participants |
| Pregabalin | Number of Participants With CGIC Scale for NeP in PP Population | Much worse | 5 Participants |
| Pregabalin | Number of Participants With CGIC Scale for NeP in PP Population | Very much worse | 0 Participants |
Secondary
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
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.
Time frame: Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | Very much improved | 968 Participants |
| Pregabalin | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | Much improved | 1313 Participants |
| Pregabalin | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | A little improved | 671 Participants |
| Pregabalin | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | No change | 141 Participants |
| Pregabalin | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | A little worse | 7 Participants |
| Pregabalin | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | Much worse | 5 Participants |
| Pregabalin | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | Very much worse | 0 Participants |
Secondary
Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
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.
Time frame: Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | Very much improved | 1027 Participants |
| Pregabalin | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | Much improved | 1187 Participants |
| Pregabalin | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | A little improved | 686 Participants |
| Pregabalin | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | No change | 195 Participants |
| Pregabalin | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | A little worse | 5 Participants |
| Pregabalin | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | Much worse | 3 Participants |
| Pregabalin | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | Very much worse | 0 Participants |
Secondary
Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
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.
Time frame: Week 6
Population: ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | Very much improved | 35 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | Much improved | 61 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | A little improved | 14 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | No change | 8 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | A little worse | 0 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | Much worse | 0 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | Very much worse | 0 Participants |
Secondary
Number of Participants With PGIC Scale for Fibromyalgia in PP Population
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.
Time frame: Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | Very much improved | 34 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | Much Improved | 61 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | A little improved | 14 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | No change | 8 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | A little worse | 0 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | Much worse | 0 Participants |
| Pregabalin | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | Very much worse | 0 Participants |
Secondary
Number of Participants With PGIC Scale for NeP in PP Population
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.
Time frame: Week 6
Population: PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With PGIC Scale for NeP in PP Population | Very much worse | 0 Participants |
| Pregabalin | Number of Participants With PGIC Scale for NeP in PP Population | Very much improved | 1018 Participants |
| Pregabalin | Number of Participants With PGIC Scale for NeP in PP Population | Much Improved | 1177 Participants |
| Pregabalin | Number of Participants With PGIC Scale for NeP in PP Population | A little improved | 680 Participants |
| Pregabalin | Number of Participants With PGIC Scale for NeP in PP Population | No change | 193 Participants |
| Pregabalin | Number of Participants With PGIC Scale for NeP in PP Population | A little worse | 5 Participants |
| Pregabalin | Number of Participants With PGIC Scale for NeP in PP Population | Much worse | 3 Participants |