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| ID | Type | Description | Link |
|---|---|---|---|
| NEP-TUNE | Other Identifier | Alias Study Number |
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Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.
General practitioners and specialists participate in the study. When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with peripheral neuropathic pain treated with Lyrica |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention. Non-interventional study | Other | No intervention. Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Average Pain Level At Month 3 Telephonic Interview | 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". | Baseline, Month 3 Telephonic Interview |
| Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview | 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". | Baseline, Month 3 Telephonic Interview |
| Change From Baseline In Least Pain Level At Month 3 Telephonic Interview | 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". | Baseline, Month 3 Telephonic Interview |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Interference Scale Score | 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. |
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Inclusion Criteria:
Subjects aged 18 years or over.
Subjects diagnosed with peripheral neuropathic pain.
Subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either.
Subjects that haven't taken the first dose of the prescribed pregabalin yet.
Exclusion Criteria:
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When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who received at least one dose of the drug under study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline In Average Pain Level At Month 3 Telephonic Interview | 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". | Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 3 Telephonic Interview |
|
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Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | General disorders | No coding dictionary | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Baseline, Month 1, 2, 3, Month 3 telephonic interview |
| Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | 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. | Month 3 telephonic interview |
| Health-related Quality of Life Scale Score | 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. | Baseline, Month 1, 2, 3 |
| Work Productivity and Activity Impairment (WPAI) Questionnaire | 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. | Baseline, Month 1, 2, 3 |
| Pregabalin Dose | 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. | After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview |
| Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | 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. | Before Baseline, Month 1, 2, 3 Visit |
| Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | 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. | After Baseline, Month 1, 2, 3 visit |
| The price |
|
| Withdrawal by Subject |
|
| Move |
|
| Deterioration of pains |
|
| Gall stone surgery |
|
| Nervous about confidentiality |
|
| Switch to carbamazapine |
|
| Adverse Event and Lack of Efficacy |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview | 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". | Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 3 Telephonic Interview |
|
|
|
|
| Primary | Change From Baseline In Least Pain Level At Month 3 Telephonic Interview | 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". | Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 3 Telephonic Interview |
|
|
|
|
| Secondary | Sleep Interference Scale Score | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 1, 2, 3, Month 3 telephonic interview |
|
|
|
| Secondary | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | 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. | Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. | Posted | Number | Participants | Month 3 telephonic interview |
|
|
|
| Secondary | Health-related Quality of Life Scale Score | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 1, 2, 3 |
|
|
|
| Secondary | Work Productivity and Activity Impairment (WPAI) Questionnaire | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 1, 2, 3 |
|
|
|
| Secondary | Pregabalin Dose | 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. | 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. | Posted | Mean | Standard Deviation | Milligram (mg) per day | After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview |
|
|
|
| Secondary | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | 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. | Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here "n" signifies pharmacological treatments received at the specified time point. | Posted | Number | Participants | Before Baseline, Month 1, 2, 3 Visit | Treatments | Treatments |
|
|
|
| Secondary | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | 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. | Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here "n" signifies pharmacological treatments received at the specified time point. | Posted | Number | Participants | After Baseline, Month 1, 2, 3 visit | Treatments | Treatments |
|
|
|
| 0 |
| 128 |
| 21 |
| 128 |
| Dizziness | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Oedema | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Vertigo | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Nausea | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Increase in weight | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Palpitations | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Erectile dysfunction | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Reduced energy | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Anxiety | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Depression | General disorders | No coding Dictionary | Non-systematic Assessment |
|
| Mood | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Head ache | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Constipation | General disorders | No coding dictionary | Non-systematic Assessment |
|
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.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| Month 3 (n= 52) |
|
| Month 3 telephonic interview (n= 86) |
|
| Title | Measurements |
|---|---|
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n= 64) |
|
| Title | Measurements |
|---|---|
|
| PWP Month 3 (n= 18) |
|
| PWI Baseline (n= 23) |
|
| PWI Month 1 (n= 24) |
|
| PWI Month 2 (n=11) |
|
| PWI Month 3 (n= 15) |
|
| PWPI Baseline (n= 25) |
|
| PWPI Month 1 (n= 25) |
|
| PWPI Month 2 (n=12) |
|
| PWPI Month 3 (n=19) |
|
| PAI Baseline (n= 29) |
|
| PAI Month 1 (n= 27) |
|
| PAI Month 2 (n=13) |
|
| PAI Month 3 (n= 23) |
|
|
| Dose Prior To Month 3 telephonic interview (n=86) |
|
| Dose After Visit: Baseline (n=84) |
|
| Dose After Visit: Month 1 (n= 64) |
|
| Dose After Visit: Month 2 (n= 48) |
|
| Dose After Visit: Month 3 (n= 48) |
|
| Title | Measurements |
|---|---|
|
| Before Baseline Visit: NSAIDs (n= 143) |
|
| Before Baseline Visit: Weak Opioids (n= 143) |
|
| Before Baseline Visit: Strong Opioids (n= 143) |
|
| Before Baseline Visit: SNRIs (n= 143) |
|
| Before Baseline Visit: L/C (n= 143) |
|
| Before Baseline Visit: Other (n= 143) |
|
| Before Month 1 Visit: No drug treatment (n= 71) |
|
| Before Month 1 Visit: TCA (n= 71) |
|
| Before Month 1 Visit: Gabapentin (n= 71) |
|
| Before Month 1 Visit: NSAIDs (n= 71) |
|
| Before Month 1 Visit: Weak Opioids (n= 71) |
|
| Before Month 1 Visit: Strong Opioids (n= 71) |
|
| Before Month 1 Visit: SNRIs (n= 71) |
|
| Before Month 1 Visit: L/C (n= 71) |
|
| Before Month 1 Visit: Other (n= 71) |
|
| Before Month 2 Visit: No drug treatment (n= 60) |
|
| Before Month 2 Visit: TCA (n= 60) |
|
| Before Month 2 Visit: Gabapentin (n= 60) |
|
| Before Month 2 Visit: NSAIDs (n= 60) |
|
| Before Month 2 Visit: Weak Opioids (n= 60) |
|
| Before Month 2 Visit: Strong Opioids (n= 60) |
|
| Before Month 2 Visit: SNRIs (n= 60) |
|
| Before Month 2 Visit: L/C (n= 60) |
|
| Before Month 2 Visit: Other (n= 60) |
|
| Before Month 3 Visit: No drug treatment (n= 58) |
|
| Before Month 3 Visit: TCA (n= 58) |
|
| Before Month 3 Visit: Gabapentin (n= 58) |
|
| Before Month 3 Visit: NSAIDs (n= 58) |
|
| Before Month 3 Visit: Weak Opioids (n= 58) |
|
| Before Month 3 Visit: Strong Opioids (n= 58) |
|
| Before Month 3 Visit: SNRIs (n= 58) |
|
| Before Month 3 Visit: L/C (n= 58) |
|
| Before Month 3 Visit: Other (n= 58) |
|
| Title | Measurements |
|---|---|
|
| After Baseline Visit: NSAIDs (n= 112) |
|
| After Baseline Visit: Weak Opioids (n= 112) |
|
| After Baseline Visit: Strong Opioids (n= 112) |
|
| After Baseline Visit: SNRIs (n= 112) |
|
| After Baseline Visit: L/C (n= 112) |
|
| After Baseline Visit: Other (n= 112) |
|
| After Month 1 Visit: No drug treatment (n= 70) |
|
| After Month 1 Visit: TCA (n= 70) |
|
| After Month 1 Visit: Gabapentin (n= 70) |
|
| After Baseline Visit: NSAIDs (n= 70) |
|
| After Month 1 Visit: Weak Opioids (n= 70) |
|
| After Month 1 Visit: Strong Opioids (n= 70) |
|
| After Month 1 Visit: SNRIs (n= 70) |
|
| After Month 1 Visit: L/C (n= 70) |
|
| After Month 1 Visit: Other (n= 70) |
|
| After Month 2 Visit: No drug treatment (n= 60) |
|
| After Month 2 Visit: TCA (n= 60) |
|
| After Month 2 Visit: Gabapentin (n= 60) |
|
| After Month 2 Visit: NSAIDs (n= 60) |
|
| After Month 2 Visit: Weak Opioids (n= 60) |
|
| After Month 2 Visit: Strong Opioids (n= 60) |
|
| After Month 2 Visit: SNRIs (n= 60) |
|
| After Month 2 Visit: L/C (n= 60) |
|
| After Month 2 Visit: Other (n= 60) |
|
| After Month 3 Visit: No drug treatment (n= 58) |
|
| After Month 3 Visit: TCA (n= 58) |
|
| After Month 3 Visit: Gabapentin (n= 58) |
|
| After Baseline Visit: NSAIDs (n= 58) |
|
| After Month 3 Visit: Weak Opioids (n= 58) |
|
| After Month 3 Visit: Strong Opioids (n= 58) |
|
| After Month 3 Visit: SNRIs (n= 58) |
|
| After Month 3 Visit: L/C (n= 58) |
|
| After Month 3 Visit: Other (n= 58) |
|