Pregabalin
DrugPregabalin 75-150 mg BID for at least 2 weeks.
Other names: Lyrica
NCT Number: NCT00892008
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pregabalin 75-150 mg BID for at least 2 weeks.
Other names: Lyrica
Time frame: 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.
Time frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
Discontinuations due to adverse events by MedDRA system organ class and preferred term.
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
Acronym: PAINS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03848143
Nervous System Diseases, Neuralgia
Lexington, Kentucky, United States
View Trial DetailsNCT06750692
Brain Diseases, Cardiovascular Diseases
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT05998369
Abdominal Pain, Autonomic Nervous System Diseases
Palo Alto, California, United States
View Trial DetailsNCT06568042
Distal Sensory Polyneuropathy, Nervous System Diseases
Chandler, Arizona, United States
View Trial Details