A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
- Registration Number
- NCT00892008
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2278
- Male or female, 18 years old and above diagnosed with neuropathic pain.
- Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Open-Label Pregabalin This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.
- Primary Outcome Measures
Name Time Method Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) Baseline through 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.
Discontinuations Due to Adverse Events Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) Discontinuations due to adverse events by MedDRA system organ class and preferred term.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Visual Analogue Scale (VAS) Score Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) 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.
VAS Pain Score at Baseline (BL) and Second Visit Baseline, Second Visit (Week ≥ 2) 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 .
VAS Pain Score at Baseline and Final Visit Baseline, Final Visit (Week 4) 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.
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits Second Visit (Week ≥ 2), Final Visit (Week 4) 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.
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits Second Visit (Week ≥ 2), Final Visit (Week 4) 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.
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit Second Visit (Week ≥ 2), Final Visit (Week 4) 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.
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit Second Visit (Week ≥ 2), Final Visit (Week 4) 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.
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist Second Visit (Week ≥ 2), Final Visit (Week 4) 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.
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit Second Visit (Week ≥ 2), Final Visit (Week 4) 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.