Neuropathic Pain
Conditions
Keywords
pregabalin, neuropathic pain, safety
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.
Interventions
DRUGPregabalin
Pregabalin 75-150 mg BID for at least 2 weeks.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 . |
Participant flow
Recruitment details
Phase 4 nationwide post-marketing surveillance study conducted between Sep 2006 and Aug 2008.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin 75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator. | 2,278 |
| Total | 2,278 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 37 |
| Overall Study | Death | 5 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 142 |
| Overall Study | Other | 378 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Customized 18-44 years | 582 participants |
| Age, Customized 45-64 years | 1054 participants |
| Age, Customized ≥ 65 years | 451 participants |
| Age, Customized unspecified | 191 participants |
| Sex/Gender, Customized female | 1324 participants |
| Sex/Gender, Customized male | 932 participants |
| Sex/Gender, Customized unspecified | 22 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 345 / 2,278 |
| serious Total, serious adverse events | 7 / 2,278 |
Outcome results
Primary
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)
Population: Safety population: all subjects who took at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Discontinuations Due to Adverse Events | Cardiac Disorders: palpitations | 1 participants |
| Pregabalin | Discontinuations Due to Adverse Events | Ear and Labyrinth Disorders: vertigo | 1 participants |
| Pregabalin | Discontinuations Due to Adverse Events | Gastrointestinal Disorders: nausea | 5 participants |
| Pregabalin | Discontinuations Due to Adverse Events | Gastrointestinal Disorders: vomiting | 3 participants |
| Pregabalin | Discontinuations Due to Adverse Events | General/ Administrative Site Conditions: asthenia | 2 participants |
| Pregabalin | Discontinuations Due to Adverse Events | Nervous System Disorders: somnolence | 26 participants |
| Pregabalin | Discontinuations Due to Adverse Events | Resp., Thoracic & Mediastinal Disorders: snoring | 1 participants |
| Pregabalin | Discontinuations Due to Adverse Events | Vascular Disorders: hypertension | 1 participants |
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.
Time frame: Baseline through Final Visit (Week 4)
Population: Safety population: all subjects who took at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Cardiac Disorders | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | palpitations (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Ear and Labyrinth Disorders | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | ear disorder (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | vertigo (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | vertigo (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Gastrointestinal Disorders | 44 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | abdominal discomfort (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | abdominal distension (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | abdominal pain (upper) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | constipation (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | constipation (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | diarrhoea (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | diarrhoea (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dry mouth (mild) | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | ill-defined disorder (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | irritability (mild) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | irritability (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | multi-organ failure (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | oedema peripheral (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | oedema peripheral (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | pyrexia (mild) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Hepatobiliary Disorders | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | jaundice (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Infections and Infestations | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | bronchopneumonia (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | pneumonia (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Investigations | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | weight increased (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Metabolism and Nutrition Disorders | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Musculoskeletal and Connective Tissue Disorders | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | muscular weakness (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | myalgia (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Neoplasms Benign, Malignant and Unspecified | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | breast cancer stage III (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | metastases to central nervous system (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | metastatic neoplasm (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Nervous System Disorders | 233 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | balance disorder (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dizziness (unspecified) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dizziness (mild) | 79 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dizziness (moderate) | 47 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | headache (mild) | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | headache (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | hypersomnia (mild) | 5 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | hypersomnia (moderate) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | incoherent (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | neuralgia (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | paraesthesia (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | sedation (moderate) | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | sedation (severe) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | somnolence (unspecified) | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | somnolence (mild) | 62 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | somnolence (moderate) | 24 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | somnolence (severe) | 4 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | syncope (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | syncope (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | tremor (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Psychiatric Disorders | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | abnormal dreams (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Skin and Subcutaneous Tissue Disorders | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | rash generalized (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Vascular Disorders | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | hypertension (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | hypotension (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | pallor (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dry mouth (moderate) | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dyspepsia (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | epigastric discomfort (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | nausea (mild) | 10 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | nausea (moderate) | 13 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | nausea (severe) | 4 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | vomiting (mild) | 8 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | vomiting (moderate) | 4 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | vomiting (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | General Disorders & Administration Site Conditions | 20 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | asthenia (mild) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | asthenia (moderate) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | asthenia (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | fatigue (moderate) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | ill-defined disorder (mild) | 5 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | ill-defined disorder (moderate) | 2 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | anorexia (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | hypoglycemia (moderate) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | increased appetite (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dizziness (severe) | 8 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | confusional state (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | insomnia (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Reproductive and Breast Disorders | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | ejaculation disorder (unspecified) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Respiratory, Thoracic and Mediastinal Disorders | 3 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dyspnoea (severe) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | dyspnoea exertional (mild) | 1 participants |
| Pregabalin | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | snoring (severe) | 1 participants |
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.
Time frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N = number of subjects with a Visual Analog Scale (VAS) pain score at Baseline Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Visual Analogue Scale (VAS) Score | Second Visit (n=1472) | 3.5 scores on scale | Standard Deviation 1.7 |
| Pregabalin | Change From Baseline in Visual Analogue Scale (VAS) Score | Final Visit (n=1126) | 5.1 scores on scale | Standard Deviation 1.8 |
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.
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=264); Final Visit: Excell | 206 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=264); Final Vst: Very Good | 8 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=264); Final Visit: Good | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=264); Final Visit: Fair | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=264); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=264); Final Visit: Missing | 50 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=775); Final Visit: Excell | 286 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=775); Final Vst: Very Good | 405 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=775); Final Visit: Good | 12 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=775); Final Visit: Fair | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=775); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=775); Final Visit: Missing | 71 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=450); Final Visit: Excellent | 34 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=450): Final Visit: Very Good | 266 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=450); Final Visit: Good | 127 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=450); Final Visit: Fair | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=450); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=450); Final Visit: Missing | 22 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=75); Final Visit: Excellent | 6 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=75); Final Visit: Very Good | 21 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=75); Final Visit: Good | 32 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=75); Final Visit: Fair | 10 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=75); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=75); Final Visit: Missing | 6 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=12); Final Visit: Excellent | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit :Poor (n=12); Final Visit: Very Good | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=12); Final Visit: Good | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=12); Final Visit: Fair | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=12); Final Visit: Poor | 3 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=12); Final Visit: Missing | 4 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=27); Final Visit: Excellent | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=27); Final Visit: Very Good | 3 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=27); Final Visit: Good | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=27); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=27); Final Visit: Missing | 23 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=27); Final Visit: Fair | 1 participants |
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.
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Excellent (n=278); Final Visit: Excell | 213 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Excellent (n=278); Final Vst: Very Good | 14 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Excellent (n=278); Final Visit: Good | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Excellent (n=278); Final Visit: Fair | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Excellent (n=278); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Excellent (n=278); Final Visit: Missing | 51 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Very Good (n=750); Final Visit: Excell | 257 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Very Good (n=750); Final Vst: Very Good | 415 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Very Good (n=750); Final Visit: Good | 13 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Very Good (n=750); Final Visit: Fair | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Very Good (n=750); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Very Good (n=750); Final Visit: Missing | 64 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Poor (n=11); Final Visit: Very Good | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Poor (n=11); Final Visit: Good | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Poor (n=11); Final Visit: Fair | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Poor (n=11); Final Visit: Poor | 3 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Poor (n=11); Final Visit: Missing | 4 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Missing (n=28); Final Visit: Excellent | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Missing (n=28); Final Visit: Very Good | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Missing (n=28); Final Visit: Fair | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Missing (n=28); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Missing (n=28); Final Visit: Missing | 24 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Good (n=465); Final Visit: Excellent | 27 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Good (n=465); Final Visit: Very Good | 255 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Good (n=465); Final Visit: Good | 151 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Good (n=465); Final Visit: Fair | 4 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Good (n=465); Final Visit: Poor | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Good (n=465); Final Visit: Missing | 26 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Fair (n=71); Final Visit: Excellent | 8 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Fair (n=71); Final Visit: Very Good | 18 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Fair (n=71); Final Visit: Good | 31 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Fair (n=71); Final Visit: Fair | 7 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Fair (n=71); Final Visit: Poor | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Fair (n=71); Final Visit: Missing | 6 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Poor (n=11); Final Visit: Excellent | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | 2nd Visit: Missing (n=28); Final Visit: Good | 0 participants |
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.
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excell (n=260) ; Final Vst:Very Good | 11 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=260); Final Visit: Good | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=260) ; Final Visit: Fair | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=778); Final Vst: Very Good | 394 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=778); Final Visit: Good | 13 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=778); Final Visit: Fair | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=778); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=778); Final Visit: Missing | 73 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=454); Final Visit: Excellent | 35 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=454); Final Visit: Very Good | 263 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=454); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=454); Final Visit: Missing | 22 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=81); Final Visit: Excellent | 9 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=81); Final Visit: Very Good | 23 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=81); Final Visit:: Good | 31 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=81); Final Visit: Fair | 9 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=81); Final Visit: Poor | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=81); Final Visit: Missing | 8 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=12); Final Visit: Excellent | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=12); Final Visit: Very Good | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=12); Final Visit: Good | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=12); Final Visit: Fair | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit::Poor (n=12); Final Visit: Poor | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=12); Final Visit: Missing | 3 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=18); Final Visit: Excellent | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=18); Final Visit: Very Good | 2 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=18); Final Visit: Good | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=18); Final Visit: Fair | 1 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=18); Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=18); Final Visit: Missing | 15 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=260); Final Vst: Excell | 201 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=260) ; Final Visit: Poor | 0 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=260); Final Visit: Missing | 47 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=778); Final Visit: Excell | 297 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=454); Final Visit: Good | 130 participants |
| Pregabalin | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=454); Final Visit: Fair | 4 participants |
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.
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=279); Final Visit: Excell | 217 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=279); Final Vst: Very Good | 8 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=279); Final Visit: Good | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=279); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=279); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Excellent (n=279); Final Visit: Missing | 53 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=813); Final Visit: Excell | 298 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=813); Final Vst: Very Good | 437 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=813); Final Visit: Good | 10 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=813); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=813); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Very Good (n=813); Final Visit: Missing | 68 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=418); Final Visit: Excellent | 19 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=418); Final Visit: Very Good | 258 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=418); Final Visit: Good | 115 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=418); Final Visit: Fair | 5 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=418); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Good (n=418); Final Visit: Missing | 21 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=66); Final Visit: Excellent | 4 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=66); Final Visit: Very Good | 20 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=66); Final Visit: Good | 28 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=66); Final Visit: Fair | 5 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=66); Final Visit: Poor | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Fair (n=66); Final Visit: Missing | 7 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=7); Final Visit: Excellent | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=7); Final Visit: Very Good | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=7); Final Visit: Good | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=7); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=7); Final Visit: Poor | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Poor (n=7); Final Visit: Missing | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=20); Final Visit: Excellent | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=20); Final Visit: Very Good | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=20); Final Visit: Good | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=20); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=20); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | 2nd Visit: Missing (n=20); Final Visit: Missing | 19 participants |
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.
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=272); Final Vst: Excellent | 209 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=272); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=272); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=272); Final Visit: Missing | 55 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=803); Final Vst: Excellent | 307 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=803); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=803); Final Visit: Missing | 65 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=438); Final Visit: Excellent | 27 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=438); Final Visit: Very Good | 267 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=438); Final Visit: Good | 119 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=438); Final Visit: Fair | 4 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=438); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=71); Final Visit: Good | 30 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=71); Final Visit: Fair | 3 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=71); Final Visit: Poor | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=71); Final Visit: Missing | 8 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=7); Final Visit: Very Good | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=7); Final Visit: Good | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=7); Final Visit: Fair | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=7); Final Visit: Poor | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=7); Final Visit: Missing | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=12); Final Visit: Excellent | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=12); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=12); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=12); Final Visit: Missing | 12 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=272); Final Vst: Very Good | 6 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Excellent (n=272); Final Visit: Good | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=803); Final Vst: Very Good | 421 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=803); Final Visit: Good | 10 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Very Good (n=803); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Good (n=438); Final Visit: Missing | 21 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=71); Final Visit: Excellent | 7 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Fair (n=71); Final Visit: Very Good | 22 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Poor (n=7); Final Visit: Excellent | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=12); Final Visit: Very Good | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | 2nd Visit: Missing (n=12); Final Visit: Good | 0 participants |
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.
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Excellent (n=309); Final Vst: Very Good | 12 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Excellent (n=309); Final Visit: Good | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Excellent (n=309); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Excellent (n=309); Final Visit: Poor | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Good (n=436); Final Visit: Very Good | 254 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Good (n=436); Final Visit: Good | 135 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Good (n=436); Final Visit: Fair | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Good (n=436); Final Visit: Poor | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Good (n=436); Final Visit: Missing | 21 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Fair (n=67); Final Visit: Very Good | 19 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Fair (n=67); Final Visit: Good | 30 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Fair (n=67); Final Visit: Fair | 5 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Fair (n=67); Final Visit: Poor | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Missing (n=21); Final Visit: Missing | 18 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Very Good (n=764); Final Visit: Missing | 67 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Excellent (n=309); Final Visit: Excell | 237 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Excellent (n=309); Final Visit: Missing | 60 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Very Good (n=764); Final Visit: Excell | 255 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Very Good (n=764); Final Vst:Very Good | 431 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Very Good (n=764); Final Visit: Good | 9 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Very Good (n=764); Final Visit: Fair | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Very Good (n=764); Final Visit: Poor | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Good (n=436); Final Visit: Excellent | 24 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Fair (n=67); Final Visit: Excellent | 6 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Fair (n=67); Final Visit: Missing | 6 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Poor (n=6); Final Visit: Excellent | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Poor (n=6); Final Visit: Very Good | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Poor (n=6); Final Visit: Good | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Poor (n=6); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Poor (n=6); Final Visit: Poor | 3 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Poor (n=6); Final Visit: Missing | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Missing (n=21); Final Visit: Excellent | 1 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Missing (n=21); Final Visit: Very Good | 2 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Missing (n=21); Final Visit: Good | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Missing (n=21); Final Visit: Fair | 0 participants |
| Pregabalin | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | 2nd Visit: Missing (n=21); Final Visit: Poor | 0 participants |
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.
Time frame: Baseline, Final Visit (Week 4)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Mild Pain (n=25); Final Visit: Mild Pain | 12 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Mild Pain (n=25); Final Visit: Moderate Pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Mild Pain (n=25); Final Visit: Severe Pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Mild Pain (n=25); Final Visit: Missing | 13 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Moderate Pain (n=450); Final Visit: Mild Pain | 272 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Moderate Pain (n=450); Final Visit: Mod. Pain | 19 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Moderate Pain (n=450); Final Visit: Sev. Pain | 1 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Moderate Pain (n=450); Final Visit: Missing | 158 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Severe Pain (n=985); Final Visit: Mod. Pain | 134 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Severe Pain (n=985); Final Visit: Severe Pain | 6 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Severe Pain (n=985); Final Visit: Missing | 243 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Worst Poss. Pain (n=98); Final Visit: Missing | 18 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Missing (n=45); Final Visit: Mild Pain | 4 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Missing (n=45); Final Visit: Missing | 39 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Severe Pain (n=985); Final Visit: Mild Pain | 602 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Worst Poss. Pain (n=98); Final Vst: Mild Pain | 54 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Worst Poss. Pain (n=98); Final Vst: Mod Pain | 25 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Worst Poss. Pain (n=98); Final Visit: Sev Pain | 1 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Missing (n=45); Final Visit: Moderate Pain | 1 participants |
| Pregabalin | VAS Pain Score at Baseline and Final Visit | BL: Missing (n=45); Final Visit: Severe Pain | 1 participants |
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 .
Time frame: Baseline, Second Visit (Week ≥ 2)
Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Missing (n=45) ; 2nd Visit: Severe Pain | 3 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Mild Pain (n=25); 2nd Visit: Mild Pain | 22 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Mild Pain (n= 25); 2nd Visit: Moderate Pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Mild Pain (n= 25); 2nd Visit: Severe Pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL:Mild Pain (n= 25); 2nd Visit: Worst Poss. Pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Moderate Pain (n=450); 2nd Visit: Mild Pain | 300 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Moderate Pain (n=450): 2nd Visit: Mod Pain | 115 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Worst Poss. Pain (n=98); 2nd Visit: Mod Pain | 49 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Moderate Pain (n=450); 2nd Visit: Severe Pain | 2 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Mod Pain (n=450); 2nd Visit: Worst Poss. Pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Moderate Pain (n=450); 2nd Visit: Missing | 33 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Severe Pain (n=985); 2nd Visit: Mild Pain | 348 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Severe Pain (n=985); 2nd Visit: Moderate Pain | 533 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Severe Pain (n=985) ; 2nd Visit: Severe Pain | 59 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Sev Pain (n=985); 2nd Visit: Worst Poss. pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Severe Pain (n=985); 2nd Visit: Missing | 45 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Worst Poss. Pain (n=98) ; 2nd Visit: Mild Pain | 18 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Worst Poss. Pain (n=98); 2nd Visit: Sev Pain | 25 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL:Wrst Poss Pain (n=98); 2nd Visit: Wrst Poss. Pn | 1 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Missing (n=45) ; 2nd Visit: Moderate Pain | 1 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Mild Pain (n= 25); 2nd Visit: Missing | 3 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Worst Poss. Pain (n=98) ; 2nd Visit: Missing | 5 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Missing (n=45); 2nd Visit: Mild Pain | 3 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Missing (n=45) ; 2nd Visit: Worst Poss. Pain | 0 participants |
| Pregabalin | VAS Pain Score at Baseline (BL) and Second Visit | BL: Missing (n=45); 2nd Visit: Missing | 38 participants |