Neuropathic Pain
Conditions
Keywords
neuropathic, pain, pregabalin, Lyrica
Brief summary
A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.
Detailed description
A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks
Interventions
DRUGPregabalin
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.
Exclusion criteria
* The patients were excluded according to the current Summary of Product Characteristics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Average Pain Scores | Baseline, Final Visit (Week 8 or discontinuation) | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine. |
| Pain Related Sleep Interference | Baseline, Final Visit (Week 8 or discontinuation) | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and Depression Symptoms | Baseline, Final Visit (Week 8 or discontinuation) | The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation. |
| Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Final Visit (Week 8 or discontinuation) | Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse. |
| Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Final Visit (Week 8 or discontinuation) | Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse. |
Participant flow
Recruitment details
The study was conducted at 23 sites in Greece by investigators contracted by and under the direction of the sponsor. This study was performed by office-based physicians and in hospitals.
Pre-assignment details
This study enrolled subjects with a confirmed diagnosis of neuropathic pain, according to the neuropathic pain diagnostic (DN4) Questionnaire, completed by the investigator at baseline
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) 275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication. | 691 |
| Total | 691 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 39 |
| Overall Study | Death | 3 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Other | 10 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) |
|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 13.7 |
| Sex/Gender, Customized Female | 434 participants |
| Sex/Gender, Customized Male | 254 participants |
| Sex/Gender, Customized Unspecified | 3 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 151 / — |
| serious Total, serious adverse events | 7 / — |
Outcome results
Primary
Daily Average Pain Scores
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.
Time frame: Baseline, Final Visit (Week 8 or discontinuation)
Population: Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Daily Average Pain Scores | Baseline | 7.61 scores on scale | Standard Deviation 1.69 |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Daily Average Pain Scores | Final visit (Week 8 or discontinuation) | 3.46 scores on scale | Standard Deviation 2.11 |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Daily Average Pain Scores | Change from baseline | -4.16 scores on scale | Standard Deviation 2.52 |
Comparison: Change from Baseline; observational studyp-value: <0.000195% CI: [-4.35, -3.97]t-test, 2 sided
Primary
Pain Related Sleep Interference
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep
Time frame: Baseline, Final Visit (Week 8 or discontinuation)
Population: Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Pain Related Sleep Interference | Baseline | 6.28 scores on a scale | Standard Deviation 2.59 |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Pain Related Sleep Interference | Final visit (Week 8 or discontinuation) | 2.27 scores on a scale | Standard Deviation 2.19 |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Pain Related Sleep Interference | Change from baseline | -4.02 scores on a scale | Standard Deviation 2.9 |
Comparison: Change from baselinep-value: <0.000195% CI: [-4.24, -3.8]t-test, 2 sided
Secondary
Anxiety and Depression Symptoms
The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.
Time frame: Baseline, Final Visit (Week 8 or discontinuation)
Population: Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward method (LOCF) was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Missing | 0 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Always | 8 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Most of the time | 14 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Fairly often | 57 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Sometimes | 199 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Rarely | 186 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Never | 183 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at baseline: Not done | 21 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Always | 27 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Most of the time | 152 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Fairly often | 168 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Sometimes | 176 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Rarely | 72 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Never | 37 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Missing | 1 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q1 at final visit: Not done | 35 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Always | 5 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Most of the time | 15 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Fairly often | 62 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Sometimes | 150 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Rarely | 196 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Never | 219 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Missing | 0 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at baseline: Not done | 21 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Always | 21 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Most of the time | 108 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Fairly often | 168 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Sometimes | 174 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Rarely | 102 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Never | 59 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Missing | 1 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q2 at final visit: Not done | 35 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Always | 48 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Most of the time | 167 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Fairly often | 190 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Sometimes | 143 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Rarely | 59 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Never | 40 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Missing | 0 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at baseline: Not done | 21 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at final visit: Always | 7 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 final visit: Most of the time | 37 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at final visit: Fairly often | 73 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at final visit: Sometimes | 179 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at final visit: Rarely | 161 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at final visit: Never | 175 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at final visit: Missing | 1 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Anxiety and Depression Symptoms | Q3 at final visit: Not done | 35 participants |
Secondary
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse.
Time frame: Final Visit (Week 8 or discontinuation)
Population: Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. Three subjects were not included in the analysis due to incomplete case report forms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Not assessed | 0 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Very much improved | 160 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Much improved | 292 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Minimally improved | 171 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | No change | 39 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Minimally worse | 1 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Much worse | 2 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Very much worse | 0 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Not done | 0 participants |
Secondary
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse.
Time frame: Final Visit (Week 8 or discontinuation)
Population: Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | No change | 44 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Not assessed | 0 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Very much improved | 175 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Much improved | 245 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Minimally improved | 193 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Minimally worse | 7 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Much worse | 2 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Very much worse | 0 participants |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Not done | 0 participants |