Trial Outcomes & Findings for NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark (NCT NCT01524796)
NCT ID: NCT01524796
Last Updated: 2021-01-28
Results Overview
Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Recruitment status
COMPLETED
Target enrollment
128 participants
Primary outcome timeframe
Baseline, Month 3 Telephonic Interview
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
Pregabalin
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Overall Study
STARTED
|
128
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Pregabalin
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
The price
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Move
|
1
|
|
Overall Study
Deterioration of pains
|
1
|
|
Overall Study
Gall stone surgery
|
1
|
|
Overall Study
Nervous about confidentiality
|
1
|
|
Overall Study
Switch to carbamazapine
|
1
|
|
Overall Study
Adverse Event and Lack of Efficacy
|
1
|
Baseline Characteristics
NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark
Baseline characteristics by cohort
| Measure |
Pregabalin
n=128 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Age, Continuous
|
58.2 Years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3 Telephonic InterviewPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Outcome measures
| Measure |
Pregabalin
n=86 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
Baseline
|
6.7 Units on a scale
Standard Deviation 1.9
|
|
Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
Change at Month 3 Telephonic Interview
|
-2.2 Units on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Baseline, Month 3 Telephonic InterviewPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Outcome measures
| Measure |
Pregabalin
n=86 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
Baseline
|
8.4 Units on a scale
Standard Deviation 1.7
|
|
Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
Change at Month 3 Telephonic Interview
|
-2.1 Units on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Baseline, Month 3 Telephonic InterviewPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Outcome measures
| Measure |
Pregabalin
n=86 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
Baseline
|
4.1 Units on a scale
Standard Deviation 2.3
|
|
Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
Change at Month 3 Telephonic Interview
|
-1.5 Units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 2, 3, Month 3 telephonic interviewPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, "n" signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, "n" signifies number of observations.
Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated "pain did not interfere with sleep" and a score of 10 indicated "pain completely interfered with sleep". Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Outcome measures
| Measure |
Pregabalin
n=86 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Sleep Interference Scale Score
Baseline (n = 71)
|
5.3 Units on a scale
Standard Deviation 3.2
|
|
Sleep Interference Scale Score
Month 1 (n= 58)
|
4.2 Units on a scale
Standard Deviation 3.1
|
|
Sleep Interference Scale Score
Month 2 (n= 37)
|
4.0 Units on a scale
Standard Deviation 2.8
|
|
Sleep Interference Scale Score
Month 3 (n= 52)
|
4.3 Units on a scale
Standard Deviation 2.9
|
|
Sleep Interference Scale Score
Month 3 telephonic interview (n= 86)
|
2.3 Units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Month 3 telephonic interviewPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
PGIC: 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). Number of participants in each category are reported.
Outcome measures
| Measure |
Pregabalin
n=86 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Very Much Improved
|
18 Participants
|
|
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Much Improved
|
35 Participants
|
|
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Minimally Improved
|
26 Participants
|
|
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
No Change
|
4 Participants
|
|
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Minimally Worse
|
3 Participants
|
|
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Much Worse
|
0 Participants
|
|
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Very Much Worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 2, 3Population: Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed "N" signifies those participants who were evaluable for this measure. For Baseline, "n"=those participants who were evaluable for this outcome. For Month 1 to Month 3, "n"=number of observations.
Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Outcome measures
| Measure |
Pregabalin
n=104 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Health-related Quality of Life Scale Score
Baseline (n= 104)
|
0.47 Units on a scale
Standard Deviation 0.26
|
|
Health-related Quality of Life Scale Score
Month 1 (n= 81)
|
0.58 Units on a scale
Standard Deviation 0.22
|
|
Health-related Quality of Life Scale Score
Month 2 (n= 52)
|
0.58 Units on a scale
Standard Deviation 0.27
|
|
Health-related Quality of Life Scale Score
Month 3 (n= 64)
|
0.63 Units on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 2, 3Population: Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed "N" signifies those participants who were evaluable for this measure. For Baseline, "n"=those participants who were evaluable for this outcome. For Month 1 to Month 3, "n"=number of observations.
WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Outcome measures
| Measure |
Pregabalin
n=29 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWP Month 1 (n= 25)
|
28.7 Units on a scale
Standard Deviation 34.7
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWP Month 2 (n=12)
|
17.8 Units on a scale
Standard Deviation 38.6
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWI Baseline (n= 23)
|
70.0 Units on a scale
Standard Deviation 22.2
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWI Month 1 (n= 24)
|
58.2 Units on a scale
Standard Deviation 28.5
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWI Month 2 (n=11)
|
48.1 Units on a scale
Standard Deviation 24.0
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWPI Baseline (n= 25)
|
63.2 Units on a scale
Standard Deviation 21.5
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWPI Month 1 (n= 25)
|
52.0 Units on a scale
Standard Deviation 25.8
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PAI Month 1 (n= 27)
|
63.7 Units on a scale
Standard Deviation 22.2
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PAI Month 3 (n= 23)
|
53.0 Units on a scale
Standard Deviation 22.2
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWP Baseline (n= 25)
|
28.4 Units on a scale
Standard Deviation 32.9
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWP Month 3 (n= 18)
|
29.9 Units on a scale
Standard Deviation 41.6
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWI Month 3 (n= 15)
|
56.3 Units on a scale
Standard Deviation 28.9
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWPI Month 2 (n=12)
|
45.8 Units on a scale
Standard Deviation 18.8
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PWPI Month 3 (n=19)
|
48.9 Units on a scale
Standard Deviation 23.1
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PAI Baseline (n= 29)
|
68.3 Units on a scale
Standard Deviation 18.3
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire
PAI Month 2 (n=13)
|
55.4 Units on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic InterviewPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, "n" signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, "n" signifies number of observations.
Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Outcome measures
| Measure |
Pregabalin
n=86 Participants
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Pregabalin Dose
Dose Prior To Visit: Month 1 (n= 64)
|
107.4 Milligram (mg) per day
Standard Deviation 112.7
|
|
Pregabalin Dose
Dose Prior To Visit: Month 2 (n= 48)
|
123.4 Milligram (mg) per day
Standard Deviation 102.0
|
|
Pregabalin Dose
Dose Prior To Visit: Month 3 (n= 48)
|
164.6 Milligram (mg) per day
Standard Deviation 128.7
|
|
Pregabalin Dose
Dose Prior To Month 3 telephonic interview (n=86)
|
240.7 Milligram (mg) per day
Standard Deviation 210.4
|
|
Pregabalin Dose
Dose After Visit: Baseline (n=84)
|
81.5 Milligram (mg) per day
Standard Deviation 89.1
|
|
Pregabalin Dose
Dose After Visit: Month 2 (n= 48)
|
145.3 Milligram (mg) per day
Standard Deviation 115.2
|
|
Pregabalin Dose
Dose After Visit: Month 3 (n= 48)
|
169.3 Milligram (mg) per day
Standard Deviation 145.3
|
|
Pregabalin Dose
Dose After Visit: Month 1 (n= 64)
|
148.4 Milligram (mg) per day
Standard Deviation 144.5
|
SECONDARY outcome
Timeframe: Before Baseline, Month 1, 2, 3 VisitPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here "n" signifies pharmacological treatments received at the specified time point.
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Outcome measures
| Measure |
Pregabalin
n=143 Treatments
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: NSAIDs (n= 143)
|
25 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: Weak Opioids (n= 143)
|
35 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: Strong Opioids (n= 143)
|
18 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: SNRIs (n= 143)
|
6 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: L/C (n= 143)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: Other (n= 143)
|
6 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: No drug treatment (n= 71)
|
23 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: TCA (n= 71)
|
11 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: Other (n= 71)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: No drug treatment (n= 60)
|
14 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: TCA (n= 60)
|
13 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: Gabapentin (n= 60)
|
2 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: NSAIDs (n= 60)
|
4 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: Weak Opioids (n= 60)
|
14 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: Strong Opioids (n= 60)
|
10 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: NSAIDs (n= 58)
|
4 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: Weak Opioids (n= 58)
|
16 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: Strong Opioids (n= 58)
|
12 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: SNRIs (n= 58)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: No drug treatment (n= 143)
|
5 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: TCA (n= 143)
|
14 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Baseline Visit: Gabapentin (n= 143)
|
33 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: Gabapentin (n= 71)
|
2 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: NSAIDs (n= 71)
|
5 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: Weak Opioids (n= 71)
|
17 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: Strong Opioids (n= 71)
|
11 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: SNRIs (n= 71)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 1 Visit: L/C (n= 71)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: SNRIs (n= 60)
|
2 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: L/C (n= 60)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 2 Visit: Other (n= 60)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: No drug treatment (n= 58)
|
12 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: TCA (n= 58)
|
13 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: Gabapentin (n= 58)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: L/C (n= 58)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Before Month 3 Visit: Other (n= 58)
|
1 Participants
|
SECONDARY outcome
Timeframe: After Baseline, Month 1, 2, 3 visitPopulation: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here "n" signifies pharmacological treatments received at the specified time point.
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Outcome measures
| Measure |
Pregabalin
n=112 Treatments
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: Strong Opioids (n= 112)
|
17 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: L/C (n= 112)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: Other (n= 112)
|
7 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: No drug treatment (n= 70)
|
23 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: TCA (n= 70)
|
14 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: Gabapentin (n= 70)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: NSAIDs (n= 70)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: Weak Opioids (n= 70)
|
15 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: Strong Opioids (n= 70)
|
15 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: SNRIs (n= 70)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: L/C (n= 70)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 1 Visit: Other (n= 70)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: Gabapentin (n= 60)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: NSAIDs (n= 60)
|
4 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: Weak Opioids (n= 60)
|
16 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: SNRIs (n= 60)
|
2 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: L/C (n= 60)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: No drug treatment (n= 58)
|
13 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: Strong Opioids (n= 58)
|
13 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: SNRIs (n= 58)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: L/C (n= 58)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: Other (n= 58)
|
1 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: No drug treatment (n= 60)
|
13 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: No drug treatment (n= 112)
|
25 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: TCA (n= 112)
|
12 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: Gabapentin (n= 112)
|
6 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: NSAIDs (n= 112)
|
16 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: Weak Opioids (n= 112)
|
24 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: SNRIs (n= 112)
|
5 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: TCA (n= 60)
|
15 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: Strong Opioids (n= 60)
|
9 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 2 Visit: Other (n= 60)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: TCA (n= 58)
|
13 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: Gabapentin (n= 58)
|
0 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Baseline Visit: NSAIDs (n= 58)
|
3 Participants
|
|
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
After Month 3 Visit: Weak Opioids (n= 58)
|
15 Participants
|
Adverse Events
Pregabalin
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregabalin
n=128 participants at risk
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
|
|---|---|
|
General disorders
Sedation
|
3.1%
4/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Dizziness
|
3.9%
5/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Oedema
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Vertigo
|
2.3%
3/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Nausea
|
2.3%
3/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Increase in weight
|
2.3%
3/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Palpitations
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Erectile dysfunction
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Reduced energy
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Anxiety
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Depression
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Mood
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Head ache
|
0.78%
1/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
|
General disorders
Constipation
|
1.6%
2/128
Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
|
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