A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin

Study Overview
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Brief Summary
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This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.

Official Title
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Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years old and above diagnosed with neuropathic pain. Exclusion Criteria: Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open-Label<br>This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice. | Drug: Pregabalin<br>* Pregabalin 75-150 mg BID for at least 2 weeks.<br>* Other names: Lyrica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken. | Baseline through Final Visit (Week 4) | 
| Discontinuations Due to Adverse Events | Discontinuations due to adverse events by MedDRA system organ class and preferred term. | Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Visual Analogue Scale (VAS) Score | Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline. | Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) | 
| VAS Pain Score at Baseline (BL) and Second Visit | VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit . | Baseline, Second Visit (Week ≥ 2) | 
| VAS Pain Score at Baseline and Final Visit | VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit. | Baseline, Final Visit (Week 4) | 
| Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) | 
| Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) | 
| Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) | 
| Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) | 
| Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) | 
| Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregabalin, neuropathic pain, safety