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

N/ACompletedNCT00892008

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.2,278 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,278

Conditions

Neuropathic Pain

Interventions

PregabalinDRUG

Pregabalin 75-150 mg BID for at least 2 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline through Final Visit (Week 4)

Discontinuations Due to Adverse Events

Discontinuations due to adverse events by MedDRA system organ class and preferred term.

Time frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)

Secondary Outcomes

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.

Time frame: 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 .

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.