Trial Outcomes & Findings for Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA (NCT NCT00843284)
NCT ID: NCT00843284
Last Updated: 2021-02-10
Results Overview
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.
COMPLETED
691 participants
Baseline, Final Visit (Week 8 or discontinuation)
2021-02-10
Participant Flow
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.
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
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
691
|
|
Overall Study
COMPLETED
|
619
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
39
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Other
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
3
|
Baseline Characteristics
Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA
Baseline characteristics by cohort
| Measure |
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
n=691 Participants
275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
|
|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
434 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
254 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unspecified
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
n=668 Participants
275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
|
|---|---|
|
Daily Average Pain Scores
Baseline
|
7.61 scores on scale
Standard Deviation 1.69
|
|
Daily Average Pain Scores
Final visit (Week 8 or discontinuation)
|
3.46 scores on scale
Standard Deviation 2.11
|
|
Daily Average Pain Scores
Change from baseline
|
-4.16 scores on scale
Standard Deviation 2.52
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
n=668 Participants
275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
|
|---|---|
|
Pain Related Sleep Interference
Baseline
|
6.28 scores on a scale
Standard Deviation 2.59
|
|
Pain Related Sleep Interference
Final visit (Week 8 or discontinuation)
|
2.27 scores on a scale
Standard Deviation 2.19
|
|
Pain Related Sleep Interference
Change from baseline
|
-4.02 scores on a scale
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
n=668 Participants
275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
|
|---|---|
|
Anxiety and Depression Symptoms
Q1 at final visit: Always
|
27 participants
|
|
Anxiety and Depression Symptoms
Q1 at final visit: Most of the time
|
152 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Fairly often
|
62 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Sometimes
|
150 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Always
|
8 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Most of the time
|
14 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Fairly often
|
57 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Sometimes
|
199 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Rarely
|
186 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Never
|
183 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Missing
|
0 participants
|
|
Anxiety and Depression Symptoms
Q1 at baseline: Not done
|
21 participants
|
|
Anxiety and Depression Symptoms
Q1 at final visit: Fairly often
|
168 participants
|
|
Anxiety and Depression Symptoms
Q1 at final visit: Sometimes
|
176 participants
|
|
Anxiety and Depression Symptoms
Q1 at final visit: Rarely
|
72 participants
|
|
Anxiety and Depression Symptoms
Q1 at final visit: Never
|
37 participants
|
|
Anxiety and Depression Symptoms
Q1 at final visit: Missing
|
1 participants
|
|
Anxiety and Depression Symptoms
Q1 at final visit: Not done
|
35 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Always
|
5 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Most of the time
|
15 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Rarely
|
196 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Never
|
219 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Missing
|
0 participants
|
|
Anxiety and Depression Symptoms
Q2 at baseline: Not done
|
21 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Always
|
21 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Most of the time
|
108 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Fairly often
|
168 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Sometimes
|
174 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Rarely
|
102 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Never
|
59 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Missing
|
1 participants
|
|
Anxiety and Depression Symptoms
Q2 at final visit: Not done
|
35 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Always
|
48 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Most of the time
|
167 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Fairly often
|
190 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Sometimes
|
143 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Rarely
|
59 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Never
|
40 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Missing
|
0 participants
|
|
Anxiety and Depression Symptoms
Q3 at baseline: Not done
|
21 participants
|
|
Anxiety and Depression Symptoms
Q3 at final visit: Always
|
7 participants
|
|
Anxiety and Depression Symptoms
Q3 final visit: Most of the time
|
37 participants
|
|
Anxiety and Depression Symptoms
Q3 at final visit: Fairly often
|
73 participants
|
|
Anxiety and Depression Symptoms
Q3 at final visit: Sometimes
|
179 participants
|
|
Anxiety and Depression Symptoms
Q3 at final visit: Rarely
|
161 participants
|
|
Anxiety and Depression Symptoms
Q3 at final visit: Never
|
175 participants
|
|
Anxiety and Depression Symptoms
Q3 at final visit: Missing
|
1 participants
|
|
Anxiety and Depression Symptoms
Q3 at final visit: Not done
|
35 participants
|
SECONDARY outcome
Timeframe: 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.
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".
Outcome measures
| Measure |
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
n=665 Participants
275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
|
|---|---|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Not assessed
|
0 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Very much improved
|
160 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Much improved
|
292 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Minimally improved
|
171 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
No change
|
39 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Minimally worse
|
1 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Much worse
|
2 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Very much worse
|
0 participants
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Not done
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse".
Outcome measures
| Measure |
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
n=666 Participants
275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
|
|---|---|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Not assessed
|
0 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Very much improved
|
175 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Much improved
|
245 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Minimally improved
|
193 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
No change
|
44 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Minimally worse
|
7 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Much worse
|
2 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Very much worse
|
0 participants
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Not done
|
0 participants
|
Adverse Events
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Serious adverse events
| Measure |
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.
|
|---|---|
|
Cardiac disorders
Cardiopulmonary failure
|
0.14%
1/691
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
1/691
|
|
Gastrointestinal disorders
Nausea
|
0.14%
1/691
|
|
General disorders
Asthenia
|
0.14%
1/691
|
|
General disorders
Death
|
0.43%
3/691
|
|
General disorders
Fatigue
|
0.14%
1/691
|
|
Nervous system disorders
Tremor
|
0.14%
1/691
|
|
Psychiatric disorders
Dysphoria
|
0.14%
1/691
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.14%
1/691
|
|
Social circumstances
Walking disability
|
0.14%
1/691
|
Other adverse events
| Measure |
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.
|
|---|---|
|
Nervous system disorders
Dizziness
|
19.2%
133/691
|
|
Surgical and medical procedures
Somnolence
|
9.7%
67/691
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER