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

Neuropathic Pain Clinical Trial

— PAINS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892008
• Other study ID #: A0081094
• Status: Completed
• Start date: September 2006
• Est. completion date: August 2008

Study information

• Verified date: January 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2278
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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