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Trial record 27 of 424 for:    Pregabalin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00892008
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : November 18, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Neuropathic Pain
Intervention Drug: Pregabalin
Enrollment 2278
Recruitment Details Phase 4 nationwide post-marketing surveillance study conducted between Sep 2006 and Aug 2008.
Pre-assignment Details  
Arm/Group Title Pregabalin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2278
Completed 1713
Not Completed 565
Reason Not Completed
Death             5
Lack of Efficacy             3
Lost to Follow-up             142
Other             378
Adverse Event             37
Arm/Group Title Pregabalin
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 2278
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2278 participants
18-44 years 582
45-64 years 1054
≥ 65 years 451
unspecified 191
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2278 participants
female 1324
male 932
unspecified 22
1.Primary Outcome
Title Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all subjects who took at least 1 dose of study medication.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2278
Measure Type: Number
Unit of Measure: participants
Cardiac Disorders 1
palpitations (mild) 1
Ear and Labyrinth Disorders 3
ear disorder (moderate) 1
vertigo (moderate) 1
vertigo (severe) 1
Gastrointestinal Disorders 44
abdominal discomfort (moderate) 1
abdominal distension (unspecified) 1
abdominal pain (upper) 1
constipation (unspecified) 1
constipation (mild) 1
diarrhoea (mild) 1
diarrhoea (moderate) 1
dry mouth (mild) 3
dry mouth (moderate) 3
dyspepsia (mild) 1
epigastric discomfort (mild) 1
nausea (mild) 10
nausea (moderate) 13
nausea (severe) 4
vomiting (mild) 8
vomiting (moderate) 4
vomiting (severe) 1
General Disorders & Administration Site Conditions 20
asthenia (mild) 2
asthenia (moderate) 2
asthenia (severe) 1
fatigue (moderate) 2
ill-defined disorder (mild) 5
ill-defined disorder (moderate) 2
ill-defined disorder (severe) 1
irritability (mild) 2
irritability (moderate) 1
multi-organ failure (unspecified) 1
oedema peripheral (unspecified) 1
oedema peripheral (moderate) 1
pyrexia (mild) 2
Hepatobiliary Disorders 1
jaundice (moderate) 1
Infections and Infestations 2
bronchopneumonia (unspecified) 1
pneumonia (unspecified) 1
Investigations 1
weight increased (moderate) 1
Metabolism and Nutrition Disorders 3
anorexia (moderate) 1
hypoglycemia (moderate) 1
increased appetite (mild) 1
Musculoskeletal and Connective Tissue Disorders 2
muscular weakness (mild) 1
myalgia (mild) 1
Neoplasms Benign, Malignant and Unspecified 3
breast cancer stage III (unspecified) 1
metastases to central nervous system (unspecified) 1
metastatic neoplasm (unspecified) 1
Nervous System Disorders 233
balance disorder (mild) 1
dizziness (unspecified) 2
dizziness (mild) 79
dizziness (moderate) 47
dizziness (severe) 8
headache (mild) 3
headache (moderate) 1
hypersomnia (mild) 5
hypersomnia (moderate) 2
incoherent (moderate) 1
neuralgia (unspecified) 1
paraesthesia (mild) 1
sedation (moderate) 3
sedation (severe) 2
somnolence (unspecified) 3
somnolence (mild) 62
somnolence (moderate) 24
somnolence (severe) 4
syncope (moderate) 1
syncope (severe) 1
tremor (moderate) 1
Psychiatric Disorders 3
abnormal dreams (moderate) 1
confusional state (mild) 1
insomnia (severe) 1
Reproductive and Breast Disorders 1
ejaculation disorder (unspecified) 1
Respiratory, Thoracic and Mediastinal Disorders 3
dyspnoea (severe) 1
dyspnoea exertional (mild) 1
snoring (severe) 1
Skin and Subcutaneous Tissue Disorders 1
rash generalized (severe) 1
Vascular Disorders 3
hypertension (unspecified) 1
hypotension (moderate) 1
pallor (mild) 1
2.Primary Outcome
Title Discontinuations Due to Adverse Events
Hide Description Discontinuations due to adverse events by MedDRA system organ class and preferred term.
Time Frame Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all subjects who took at least one dose of study medication.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2278
Measure Type: Number
Unit of Measure: participants
Cardiac Disorders: palpitations 1
Ear and Labyrinth Disorders: vertigo 1
Gastrointestinal Disorders: nausea 5
Gastrointestinal Disorders: vomiting 3
General/ Administrative Site Conditions: asthenia 2
Nervous System Disorders: somnolence 26
Resp., Thoracic & Mediastinal Disorders: snoring 1
Vascular Disorders: hypertension 1
3.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS) Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1558
Mean (Standard Deviation)
Unit of Measure: scores on scale
Second Visit (n=1472) 3.5  (1.7)
Final Visit (n=1126) 5.1  (1.8)
4.Secondary Outcome
Title VAS Pain Score at Baseline (BL) and Second Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
BL: Mild Pain (n=25); 2nd Visit: Mild Pain 22
BL: Mild Pain (n= 25); 2nd Visit: Moderate Pain 0
BL: Mild Pain (n= 25); 2nd Visit: Severe Pain 0
BL:Mild Pain (n= 25); 2nd Visit: Worst Poss. Pain 0
BL: Mild Pain (n= 25); 2nd Visit: Missing 3
BL: Moderate Pain (n=450); 2nd Visit: Mild Pain 300
BL: Moderate Pain (n=450): 2nd Visit: Mod Pain 115
BL: Moderate Pain (n=450); 2nd Visit: Severe Pain 2
BL: Mod Pain (n=450); 2nd Visit: Worst Poss. Pain 0
BL: Moderate Pain (n=450); 2nd Visit: Missing 33
BL: Severe Pain (n=985); 2nd Visit: Mild Pain 348
BL: Severe Pain (n=985); 2nd Visit: Moderate Pain 533
BL: Severe Pain (n=985) ; 2nd Visit: Severe Pain 59
BL: Sev Pain (n=985); 2nd Visit: Worst Poss. pain 0
BL: Severe Pain (n=985); 2nd Visit: Missing 45
BL: Worst Poss. Pain (n=98) ; 2nd Visit: Mild Pain 18
BL: Worst Poss. Pain (n=98); 2nd Visit: Mod Pain 49
BL: Worst Poss. Pain (n=98); 2nd Visit: Sev Pain 25
BL:Wrst Poss Pain (n=98); 2nd Visit: Wrst Poss. Pn 1
BL: Worst Poss. Pain (n=98) ; 2nd Visit: Missing 5
BL: Missing (n=45); 2nd Visit: Mild Pain 3
BL: Missing (n=45) ; 2nd Visit: Moderate Pain 1
BL: Missing (n=45) ; 2nd Visit: Severe Pain 3
BL: Missing (n=45) ; 2nd Visit: Worst Poss. Pain 0
BL: Missing (n=45); 2nd Visit: Missing 38
5.Secondary Outcome
Title VAS Pain Score at Baseline and Final Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
BL: Mild Pain (n=25); Final Visit: Mild Pain 12
BL: Mild Pain (n=25); Final Visit: Moderate Pain 0
BL: Mild Pain (n=25); Final Visit: Severe Pain 0
BL: Mild Pain (n=25); Final Visit: Missing 13
BL: Moderate Pain (n=450); Final Visit: Mild Pain 272
BL: Moderate Pain (n=450); Final Visit: Mod. Pain 19
BL: Moderate Pain (n=450); Final Visit: Sev. Pain 1
BL: Moderate Pain (n=450); Final Visit: Missing 158
BL: Severe Pain (n=985); Final Visit: Mild Pain 602
BL: Severe Pain (n=985); Final Visit: Mod. Pain 134
BL: Severe Pain (n=985); Final Visit: Severe Pain 6
BL: Severe Pain (n=985); Final Visit: Missing 243
BL: Worst Poss. Pain (n=98); Final Vst: Mild Pain 54
BL: Worst Poss. Pain (n=98); Final Vst: Mod Pain 25
BL: Worst Poss. Pain (n=98); Final Visit: Sev Pain 1
BL: Worst Poss. Pain (n=98); Final Visit: Missing 18
BL: Missing (n=45); Final Visit: Mild Pain 4
BL: Missing (n=45); Final Visit: Moderate Pain 1
BL: Missing (n=45); Final Visit: Severe Pain 1
BL: Missing (n=45); Final Visit: Missing 39
6.Secondary Outcome
Title Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
2nd Visit: Excellent (n=272); Final Vst: Excellent 209
2nd Visit: Excellent (n=272); Final Vst: Very Good 6
2nd Visit: Excellent (n=272); Final Visit: Good 2
2nd Visit: Excellent (n=272); Final Visit: Fair 0
2nd Visit: Excellent (n=272); Final Visit: Poor 0
2nd Visit: Excellent (n=272); Final Visit: Missing 55
2nd Visit: Very Good (n=803); Final Vst: Excellent 307
2nd Visit: Very Good (n=803); Final Vst: Very Good 421
2nd Visit: Very Good (n=803); Final Visit: Good 10
2nd Visit: Very Good (n=803); Final Visit: Fair 0
2nd Visit: Very Good (n=803); Final Visit: Poor 0
2nd Visit: Very Good (n=803); Final Visit: Missing 65
2nd Visit: Good (n=438); Final Visit: Excellent 27
2nd Visit: Good (n=438); Final Visit: Very Good 267
2nd Visit: Good (n=438); Final Visit: Good 119
2nd Visit: Good (n=438); Final Visit: Fair 4
2nd Visit: Good (n=438); Final Visit: Poor 0
2nd Visit: Good (n=438); Final Visit: Missing 21
2nd Visit: Fair (n=71); Final Visit: Excellent 7
2nd Visit: Fair (n=71); Final Visit: Very Good 22
2nd Visit: Fair (n=71); Final Visit: Good 30
2nd Visit: Fair (n=71); Final Visit: Fair 3
2nd Visit: Fair (n=71); Final Visit: Poor 1
2nd Visit: Fair (n=71); Final Visit: Missing 8
2nd Visit: Poor (n=7); Final Visit: Excellent 0
2nd Visit: Poor (n=7); Final Visit: Very Good 1
2nd Visit: Poor (n=7); Final Visit: Good 2
2nd Visit: Poor (n=7); Final Visit: Fair 1
2nd Visit: Poor (n=7); Final Visit: Poor 1
2nd Visit: Poor (n=7); Final Visit: Missing 2
2nd Visit: Missing (n=12); Final Visit: Excellent 0
2nd Visit: Missing (n=12); Final Visit: Very Good 0
2nd Visit: Missing (n=12); Final Visit: Good 0
2nd Visit: Missing (n=12); Final Visit: Fair 0
2nd Visit: Missing (n=12); Final Visit: Poor 0
2nd Visit: Missing (n=12); Final Visit: Missing 12
7.Secondary Outcome
Title Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
2nd Visit: Excellent (n=260); Final Vst: Excell 201
2nd Visit: Excell (n=260) ; Final Vst:Very Good 11
2nd Visit: Excellent (n=260); Final Visit: Good 1
2nd Visit: Excellent (n=260) ; Final Visit: Fair 0
2nd Visit: Excellent (n=260) ; Final Visit: Poor 0
2nd Visit: Excellent (n=260); Final Visit: Missing 47
2nd Visit: Very Good (n=778); Final Visit: Excell 297
2nd Visit: Very Good (n=778); Final Vst: Very Good 394
2nd Visit: Very Good (n=778); Final Visit: Good 13
2nd Visit: Very Good (n=778); Final Visit: Fair 1
2nd Visit: Very Good (n=778); Final Visit: Poor 0
2nd Visit: Very Good (n=778); Final Visit: Missing 73
2nd Visit: Good (n=454); Final Visit: Excellent 35
2nd Visit: Good (n=454); Final Visit: Very Good 263
2nd Visit: Good (n=454); Final Visit: Good 130
2nd Visit: Good (n=454); Final Visit: Fair 4
2nd Visit: Good (n=454); Final Visit: Poor 0
2nd Visit: Good (n=454); Final Visit: Missing 22
2nd Visit: Fair (n=81); Final Visit: Excellent 9
2nd Visit: Fair (n=81); Final Visit: Very Good 23
2nd Visit: Fair (n=81); Final Visit:: Good 31
2nd Visit: Fair (n=81); Final Visit: Fair 9
2nd Visit: Fair (n=81); Final Visit: Poor 1
2nd Visit: Fair (n=81); Final Visit: Missing 8
2nd Visit: Poor (n=12); Final Visit: Excellent 1
2nd Visit: Poor (n=12); Final Visit: Very Good 2
2nd Visit: Poor (n=12); Final Visit: Good 2
2nd Visit: Poor (n=12); Final Visit: Fair 2
2nd Visit::Poor (n=12); Final Visit: Poor 2
2nd Visit: Poor (n=12); Final Visit: Missing 3
2nd Visit: Missing (n=18); Final Visit: Excellent 0
2nd Visit: Missing (n=18); Final Visit: Very Good 2
2nd Visit: Missing (n=18); Final Visit: Good 0
2nd Visit: Missing (n=18); Final Visit: Fair 1
2nd Visit: Missing (n=18); Final Visit: Poor 0
2nd Visit: Missing (n=18); Final Visit: Missing 15
8.Secondary Outcome
Title Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
2nd Visit: Excellent (n=279); Final Visit: Excell 217
2nd Visit: Excellent (n=279); Final Vst: Very Good 8
2nd Visit: Excellent (n=279); Final Visit: Good 1
2nd Visit: Excellent (n=279); Final Visit: Fair 0
2nd Visit: Excellent (n=279); Final Visit: Poor 0
2nd Visit: Excellent (n=279); Final Visit: Missing 53
2nd Visit: Very Good (n=813); Final Visit: Excell 298
2nd Visit: Very Good (n=813); Final Vst: Very Good 437
2nd Visit: Very Good (n=813); Final Visit: Good 10
2nd Visit: Very Good (n=813); Final Visit: Fair 0
2nd Visit: Very Good (n=813); Final Visit: Poor 0
2nd Visit: Very Good (n=813); Final Visit: Missing 68
2nd Visit: Good (n=418); Final Visit: Excellent 19
2nd Visit: Good (n=418); Final Visit: Very Good 258
2nd Visit: Good (n=418); Final Visit: Good 115
2nd Visit: Good (n=418); Final Visit: Fair 5
2nd Visit: Good (n=418); Final Visit: Poor 0
2nd Visit: Good (n=418); Final Visit: Missing 21
2nd Visit: Fair (n=66); Final Visit: Excellent 4
2nd Visit: Fair (n=66); Final Visit: Very Good 20
2nd Visit: Fair (n=66); Final Visit: Good 28
2nd Visit: Fair (n=66); Final Visit: Fair 5
2nd Visit: Fair (n=66); Final Visit: Poor 2
2nd Visit: Fair (n=66); Final Visit: Missing 7
2nd Visit: Poor (n=7); Final Visit: Excellent 0
2nd Visit: Poor (n=7); Final Visit: Very Good 2
2nd Visit: Poor (n=7); Final Visit: Good 2
2nd Visit: Poor (n=7); Final Visit: Fair 0
2nd Visit: Poor (n=7); Final Visit: Poor 1
2nd Visit: Poor (n=7); Final Visit: Missing 2
2nd Visit: Missing (n=20); Final Visit: Excellent 0
2nd Visit: Missing (n=20); Final Visit: Very Good 1
2nd Visit: Missing (n=20); Final Visit: Good 0
2nd Visit: Missing (n=20); Final Visit: Fair 0
2nd Visit: Missing (n=20); Final Visit: Poor 0
2nd Visit: Missing (n=20); Final Visit: Missing 19
9.Secondary Outcome
Title Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
2nd Visit: Excellent (n=264); Final Visit: Excell 206
2nd Visit: Excellent (n=264); Final Vst: Very Good 8
2nd Visit: Excellent (n=264); Final Visit: Good 0
2nd Visit: Excellent (n=264); Final Visit: Fair 0
2nd Visit: Excellent (n=264); Final Visit: Poor 0
2nd Visit: Excellent (n=264); Final Visit: Missing 50
2nd Visit: Very Good (n=775); Final Visit: Excell 286
2nd Visit: Very Good (n=775); Final Vst: Very Good 405
2nd Visit: Very Good (n=775); Final Visit: Good 12
2nd Visit: Very Good (n=775); Final Visit: Fair 1
2nd Visit: Very Good (n=775); Final Visit: Poor 0
2nd Visit: Very Good (n=775); Final Visit: Missing 71
2nd Visit: Good (n=450); Final Visit: Excellent 34
2nd Visit: Good (n=450): Final Visit: Very Good 266
2nd Visit: Good (n=450); Final Visit: Good 127
2nd Visit: Good (n=450); Final Visit: Fair 1
2nd Visit: Good (n=450); Final Visit: Poor 0
2nd Visit: Good (n=450); Final Visit: Missing 22
2nd Visit: Fair (n=75); Final Visit: Excellent 6
2nd Visit: Fair (n=75); Final Visit: Very Good 21
2nd Visit: Fair (n=75); Final Visit: Good 32
2nd Visit: Fair (n=75); Final Visit: Fair 10
2nd Visit: Fair (n=75); Final Visit: Poor 0
2nd Visit: Fair (n=75); Final Visit: Missing 6
2nd Visit: Poor (n=12); Final Visit: Excellent 1
2nd Visit :Poor (n=12); Final Visit: Very Good 2
2nd Visit: Poor (n=12); Final Visit: Good 2
2nd Visit: Poor (n=12); Final Visit: Fair 0
2nd Visit: Poor (n=12); Final Visit: Poor 3
2nd Visit: Poor (n=12); Final Visit: Missing 4
2nd Visit: Missing (n=27); Final Visit: Excellent 0
2nd Visit: Missing (n=27); Final Visit: Very Good 3
2nd Visit: Missing (n=27); Final Visit: Good 0
2nd Visit: Missing (n=27); Final Visit: Fair 1
2nd Visit: Missing (n=27); Final Visit: Poor 0
2nd Visit: Missing (n=27); Final Visit: Missing 23
10.Secondary Outcome
Title Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
2nd Visit: Excellent (n=309); Final Visit: Excell 237
2nd Visit: Excellent (n=309); Final Vst: Very Good 12
2nd Visit: Excellent (n=309); Final Visit: Good 0
2nd Visit: Excellent (n=309); Final Visit: Fair 0
2nd Visit: Excellent (n=309); Final Visit: Poor 0
2nd Visit: Excellent (n=309); Final Visit: Missing 60
2nd Visit: Very Good (n=764); Final Visit: Excell 255
2nd Visit: Very Good (n=764); Final Vst:Very Good 431
2nd Visit: Very Good (n=764); Final Visit: Good 9
2nd Visit: Very Good (n=764); Final Visit: Fair 1
2nd Visit: Very Good (n=764); Final Visit: Poor 1
2nd Visit: Very Good (n=764); Final Visit: Missing 67
2nd Visit: Good (n=436); Final Visit: Excellent 24
2nd Visit: Good (n=436); Final Visit: Very Good 254
2nd Visit: Good (n=436); Final Visit: Good 135
2nd Visit: Good (n=436); Final Visit: Fair 1
2nd Visit: Good (n=436); Final Visit: Poor 1
2nd Visit: Good (n=436); Final Visit: Missing 21
2nd Visit: Fair (n=67); Final Visit: Excellent 6
2nd Visit: Fair (n=67); Final Visit: Very Good 19
2nd Visit: Fair (n=67); Final Visit: Good 30
2nd Visit: Fair (n=67); Final Visit: Fair 5
2nd Visit: Fair (n=67); Final Visit: Poor 1
2nd Visit: Fair (n=67); Final Visit: Missing 6
2nd Visit: Poor (n=6); Final Visit: Excellent 1
2nd Visit: Poor (n=6); Final Visit: Very Good 0
2nd Visit: Poor (n=6); Final Visit: Good 1
2nd Visit: Poor (n=6); Final Visit: Fair 0
2nd Visit: Poor (n=6); Final Visit: Poor 3
2nd Visit: Poor (n=6); Final Visit: Missing 1
2nd Visit: Missing (n=21); Final Visit: Excellent 1
2nd Visit: Missing (n=21); Final Visit: Very Good 2
2nd Visit: Missing (n=21); Final Visit: Good 0
2nd Visit: Missing (n=21); Final Visit: Fair 0
2nd Visit: Missing (n=21); Final Visit: Poor 0
2nd Visit: Missing (n=21); Final Visit: Missing 18
11.Secondary Outcome
Title Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Pregabalin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1603
Measure Type: Number
Unit of Measure: participants
2nd Visit: Excellent (n=278); Final Visit: Excell 213
2nd Visit: Excellent (n=278); Final Vst: Very Good 14
2nd Visit: Excellent (n=278); Final Visit: Good 0
2nd Visit: Excellent (n=278); Final Visit: Fair 0
2nd Visit: Excellent (n=278); Final Visit: Poor 0
2nd Visit: Excellent (n=278); Final Visit: Missing 51
2nd Visit: Very Good (n=750); Final Visit: Excell 257
2nd Visit: Very Good (n=750); Final Vst: Very Good 415
2nd Visit: Very Good (n=750); Final Visit: Good 13
2nd Visit: Very Good (n=750); Final Visit: Fair 1
2nd Visit: Very Good (n=750); Final Visit: Poor 0
2nd Visit: Very Good (n=750); Final Visit: Missing 64
2nd Visit: Good (n=465); Final Visit: Excellent 27
2nd Visit: Good (n=465); Final Visit: Very Good 255
2nd Visit: Good (n=465); Final Visit: Good 151
2nd Visit: Good (n=465); Final Visit: Fair 4
2nd Visit: Good (n=465); Final Visit: Poor 2
2nd Visit: Good (n=465); Final Visit: Missing 26
2nd Visit: Fair (n=71); Final Visit: Excellent 8
2nd Visit: Fair (n=71); Final Visit: Very Good 18
2nd Visit: Fair (n=71); Final Visit: Good 31
2nd Visit: Fair (n=71); Final Visit: Fair 7
2nd Visit: Fair (n=71); Final Visit: Poor 1
2nd Visit: Fair (n=71); Final Visit: Missing 6
2nd Visit: Poor (n=11); Final Visit: Excellent 1
2nd Visit: Poor (n=11); Final Visit: Very Good 2
2nd Visit: Poor (n=11); Final Visit: Good 1
2nd Visit: Poor (n=11); Final Visit: Fair 0
2nd Visit: Poor (n=11); Final Visit: Poor 3
2nd Visit: Poor (n=11); Final Visit: Missing 4
2nd Visit: Missing (n=28); Final Visit: Excellent 1
2nd Visit: Missing (n=28); Final Visit: Very Good 2
2nd Visit: Missing (n=28); Final Visit: Good 0
2nd Visit: Missing (n=28); Final Visit: Fair 1
2nd Visit: Missing (n=28); Final Visit: Poor 0
2nd Visit: Missing (n=28); Final Visit: Missing 24
Time Frame Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin
Hide Arm/Group Description 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.
All-Cause Mortality
Pregabalin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin
Affected / at Risk (%)
Total   7/2278 (0.31%) 
General disorders   
Asthenia  1  1/2278 (0.04%) 
Multi-organ failure  1  1/2278 (0.04%) 
Infections and infestations   
Bronchopneumonia  1  1/2278 (0.04%) 
Pneumonia  1  1/2278 (0.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer stage III  1  1/2278 (0.04%) 
Metastases to central nervous system  1  1/2278 (0.04%) 
Metastatic neoplasm  1  1/2278 (0.04%) 
Nervous system disorders   
Dizziness  1  1/2278 (0.04%) 
Neuralgia  1  1/2278 (0.04%) 
Sedation  1  1/2278 (0.04%) 
Somnolence  1  1/2278 (0.04%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/2278 (0.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin
Affected / at Risk (%)
Total   345/2278 (15.14%) 
Cardiac disorders   
Palpitations  1  1/2278 (0.04%) 
Ear and labyrinth disorders   
Ear disorder  1  1/2278 (0.04%) 
Vertigo  1  2/2278 (0.09%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/2278 (0.04%) 
Abdominal distension  1  1/2278 (0.04%) 
Abdominal pain upper  1  1/2278 (0.04%) 
Constipation  1  2/2278 (0.09%) 
Diarrhoea  1  2/2278 (0.09%) 
Dry mouth  1  6/2278 (0.26%) 
Dyspepsia  1  1/2278 (0.04%) 
Epigastric discomfort  1  1/2278 (0.04%) 
Nausea  1  27/2278 (1.19%) 
Vomiting  1  13/2278 (0.57%) 
General disorders   
Asthenia  1  4/2278 (0.18%) 
Fatigue  1  2/2278 (0.09%) 
Ill-defined disorder  1  8/2278 (0.35%) 
Irritability  1  3/2278 (0.13%) 
Oedema peripheral  1  2/2278 (0.09%) 
Pyrexia  1  2/2278 (0.09%) 
Hepatobiliary disorders   
Jaundice  1  1/2278 (0.04%) 
Investigations   
Weight increased  1  1/2278 (0.04%) 
Metabolism and nutrition disorders   
Anorexia  1  1/2278 (0.04%) 
Hypoglycaemia  1  1/2278 (0.04%) 
Increased appetite  1  1/2278 (0.04%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/2278 (0.04%) 
Myalgia  1  1/2278 (0.04%) 
Nervous system disorders   
Balance disorder  1  1/2278 (0.04%) 
Dizziness  1  135/2278 (5.93%) 
Headache  1  4/2278 (0.18%) 
Hypersomnia  1  7/2278 (0.31%) 
Incoherent  1  1/2278 (0.04%) 
Paraesthesia  1  1/2278 (0.04%) 
Sedation  1  4/2278 (0.18%) 
Somnolence  1  92/2278 (4.04%) 
Syncope  1  2/2278 (0.09%) 
Tremor  1  1/2278 (0.04%) 
Psychiatric disorders   
Abnormal dreams  1  1/2278 (0.04%) 
Confusional state  1  1/2278 (0.04%) 
Insomnia  1  1/2278 (0.04%) 
Reproductive system and breast disorders   
Ejaculation disorder  1  1/2278 (0.04%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea exertional  1  1/2278 (0.04%) 
Snoring  1  1/2278 (0.04%) 
Skin and subcutaneous tissue disorders   
Rash generalized  1  1/2278 (0.04%) 
Vascular disorders   
Hypertension  1  1/2278 (0.04%) 
Hypotension  1  1/2278 (0.04%) 
Pallor  1  1/2278 (0.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00892008     History of Changes
Other Study ID Numbers: A0081094
First Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: August 27, 2009
Results First Posted: November 18, 2009
Last Update Posted: January 12, 2010