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

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

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 Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Pregabalin

• Study Type: Observational
• Enrollment (Actual): 2278

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or female, 18 years and above diagnosed with neuropathic pain.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open-Label; This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.	Drug: Pregabalin; Pregabalin 75-150 mg BID for at least 2 weeks.; Other Names: Lyrica

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): May 1, 2009

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: safety; pregabalin; neuropathic pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081094