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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00892008
Collaborator
(none)
2,278
Enrollment
23
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
2278 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Open-Label

This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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.

    2. 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 .

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT00892008
    Other Study ID Numbers:
    • A0081094
    First Posted:
    May 1, 2009
    Last Update Posted:
    Jan 25, 2021
    Last Verified:
    Jan 1, 2010
    Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    pregabalin
    neuropathic pain
    safety
    Additional relevant MeSH terms:
    Neuralgia
    Pregabalin

    Study Results

    Participant Flow

    Recruitment Details Phase 4 nationwide post-marketing surveillance study conducted between Sep 2006 and Aug 2008.
    Pre-assignment Detail
    Arm/Group Title Pregabalin
    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

    Baseline Characteristics

    Arm/Group Title Pregabalin
    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 Participants 2278
    Age, Customized (participants) [Number]
    18-44 years
    582
    25.5%
    45-64 years
    1054
    46.3%
    ≥ 65 years
    451
    19.8%
    unspecified
    191
    8.4%
    Sex/Gender, Customized (participants) [Number]
    female
    1324
    58.1%
    male
    932
    40.9%
    unspecified
    22
    1%

    Outcome Measures

    1. Primary Outcome
    Title Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
    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)

    Outcome Measure Data

    Analysis Population Description
    Safety population: all subjects who took at least 1 dose of study medication.
    Arm/Group Title Pregabalin
    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.
    Measure Participants 2278
    Cardiac Disorders
    1
    0%
    palpitations (mild)
    1
    0%
    Ear and Labyrinth Disorders
    3
    0.1%
    ear disorder (moderate)
    1
    0%
    vertigo (moderate)
    1
    0%
    vertigo (severe)
    1
    0%
    Gastrointestinal Disorders
    44
    1.9%
    abdominal discomfort (moderate)
    1
    0%
    abdominal distension (unspecified)
    1
    0%
    abdominal pain (upper)
    1
    0%
    constipation (unspecified)
    1
    0%
    constipation (mild)
    1
    0%
    diarrhoea (mild)
    1
    0%
    diarrhoea (moderate)
    1
    0%
    dry mouth (mild)
    3
    0.1%
    dry mouth (moderate)
    3
    0.1%
    dyspepsia (mild)
    1
    0%
    epigastric discomfort (mild)
    1
    0%
    nausea (mild)
    10
    0.4%
    nausea (moderate)
    13
    0.6%
    nausea (severe)
    4
    0.2%
    vomiting (mild)
    8
    0.4%
    vomiting (moderate)
    4
    0.2%
    vomiting (severe)
    1
    0%
    General Disorders & Administration Site Conditions
    20
    0.9%
    asthenia (mild)
    2
    0.1%
    asthenia (moderate)
    2
    0.1%
    asthenia (severe)
    1
    0%
    fatigue (moderate)
    2
    0.1%
    ill-defined disorder (mild)
    5
    0.2%
    ill-defined disorder (moderate)
    2
    0.1%
    ill-defined disorder (severe)
    1
    0%
    irritability (mild)
    2
    0.1%
    irritability (moderate)
    1
    0%
    multi-organ failure (unspecified)
    1
    0%
    oedema peripheral (unspecified)
    1
    0%
    oedema peripheral (moderate)
    1
    0%
    pyrexia (mild)
    2
    0.1%
    Hepatobiliary Disorders
    1
    0%
    jaundice (moderate)
    1
    0%
    Infections and Infestations
    2
    0.1%
    bronchopneumonia (unspecified)
    1
    0%
    pneumonia (unspecified)
    1
    0%
    Investigations
    1
    0%
    weight increased (moderate)
    1
    0%
    Metabolism and Nutrition Disorders
    3
    0.1%
    anorexia (moderate)
    1
    0%
    hypoglycemia (moderate)
    1
    0%
    increased appetite (mild)
    1
    0%
    Musculoskeletal and Connective Tissue Disorders
    2
    0.1%
    muscular weakness (mild)
    1
    0%
    myalgia (mild)
    1
    0%
    Neoplasms Benign, Malignant and Unspecified
    3
    0.1%
    breast cancer stage III (unspecified)
    1
    0%
    metastases to central nervous system (unspecified)
    1
    0%
    metastatic neoplasm (unspecified)
    1
    0%
    Nervous System Disorders
    233
    10.2%
    balance disorder (mild)
    1
    0%
    dizziness (unspecified)
    2
    0.1%
    dizziness (mild)
    79
    3.5%
    dizziness (moderate)
    47
    2.1%
    dizziness (severe)
    8
    0.4%
    headache (mild)
    3
    0.1%
    headache (moderate)
    1
    0%
    hypersomnia (mild)
    5
    0.2%
    hypersomnia (moderate)
    2
    0.1%
    incoherent (moderate)
    1
    0%
    neuralgia (unspecified)
    1
    0%
    paraesthesia (mild)
    1
    0%
    sedation (moderate)
    3
    0.1%
    sedation (severe)
    2
    0.1%
    somnolence (unspecified)
    3
    0.1%
    somnolence (mild)
    62
    2.7%
    somnolence (moderate)
    24
    1.1%
    somnolence (severe)
    4
    0.2%
    syncope (moderate)
    1
    0%
    syncope (severe)
    1
    0%
    tremor (moderate)
    1
    0%
    Psychiatric Disorders
    3
    0.1%
    abnormal dreams (moderate)
    1
    0%
    confusional state (mild)
    1
    0%
    insomnia (severe)
    1
    0%
    Reproductive and Breast Disorders
    1
    0%
    ejaculation disorder (unspecified)
    1
    0%
    Respiratory, Thoracic and Mediastinal Disorders
    3
    0.1%
    dyspnoea (severe)
    1
    0%
    dyspnoea exertional (mild)
    1
    0%
    snoring (severe)
    1
    0%
    Skin and Subcutaneous Tissue Disorders
    1
    0%
    rash generalized (severe)
    1
    0%
    Vascular Disorders
    3
    0.1%
    hypertension (unspecified)
    1
    0%
    hypotension (moderate)
    1
    0%
    pallor (mild)
    1
    0%
    2. Secondary Outcome
    Title Change From Baseline in Visual Analogue Scale (VAS) Score
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1558
    Second Visit (n=1472)
    3.5
    (1.7)
    Final Visit (n=1126)
    5.1
    (1.8)
    3. Secondary Outcome
    Title VAS Pain Score at Baseline (BL) and Second Visit
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    BL: Mild Pain (n=25); 2nd Visit: Mild Pain
    22
    1%
    BL: Mild Pain (n= 25); 2nd Visit: Moderate Pain
    0
    0%
    BL: Mild Pain (n= 25); 2nd Visit: Severe Pain
    0
    0%
    BL:Mild Pain (n= 25); 2nd Visit: Worst Poss. Pain
    0
    0%
    BL: Mild Pain (n= 25); 2nd Visit: Missing
    3
    0.1%
    BL: Moderate Pain (n=450); 2nd Visit: Mild Pain
    300
    13.2%
    BL: Moderate Pain (n=450): 2nd Visit: Mod Pain
    115
    5%
    BL: Moderate Pain (n=450); 2nd Visit: Severe Pain
    2
    0.1%
    BL: Mod Pain (n=450); 2nd Visit: Worst Poss. Pain
    0
    0%
    BL: Moderate Pain (n=450); 2nd Visit: Missing
    33
    1.4%
    BL: Severe Pain (n=985); 2nd Visit: Mild Pain
    348
    15.3%
    BL: Severe Pain (n=985); 2nd Visit: Moderate Pain
    533
    23.4%
    BL: Severe Pain (n=985) ; 2nd Visit: Severe Pain
    59
    2.6%
    BL: Sev Pain (n=985); 2nd Visit: Worst Poss. pain
    0
    0%
    BL: Severe Pain (n=985); 2nd Visit: Missing
    45
    2%
    BL: Worst Poss. Pain (n=98) ; 2nd Visit: Mild Pain
    18
    0.8%
    BL: Worst Poss. Pain (n=98); 2nd Visit: Mod Pain
    49
    2.2%
    BL: Worst Poss. Pain (n=98); 2nd Visit: Sev Pain
    25
    1.1%
    BL:Wrst Poss Pain (n=98); 2nd Visit: Wrst Poss. Pn
    1
    0%
    BL: Worst Poss. Pain (n=98) ; 2nd Visit: Missing
    5
    0.2%
    BL: Missing (n=45); 2nd Visit: Mild Pain
    3
    0.1%
    BL: Missing (n=45) ; 2nd Visit: Moderate Pain
    1
    0%
    BL: Missing (n=45) ; 2nd Visit: Severe Pain
    3
    0.1%
    BL: Missing (n=45) ; 2nd Visit: Worst Poss. Pain
    0
    0%
    BL: Missing (n=45); 2nd Visit: Missing
    38
    1.7%
    4. Secondary Outcome
    Title VAS Pain Score at Baseline and Final Visit
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    BL: Mild Pain (n=25); Final Visit: Mild Pain
    12
    0.5%
    BL: Mild Pain (n=25); Final Visit: Moderate Pain
    0
    0%
    BL: Mild Pain (n=25); Final Visit: Severe Pain
    0
    0%
    BL: Mild Pain (n=25); Final Visit: Missing
    13
    0.6%
    BL: Moderate Pain (n=450); Final Visit: Mild Pain
    272
    11.9%
    BL: Moderate Pain (n=450); Final Visit: Mod. Pain
    19
    0.8%
    BL: Moderate Pain (n=450); Final Visit: Sev. Pain
    1
    0%
    BL: Moderate Pain (n=450); Final Visit: Missing
    158
    6.9%
    BL: Severe Pain (n=985); Final Visit: Mild Pain
    602
    26.4%
    BL: Severe Pain (n=985); Final Visit: Mod. Pain
    134
    5.9%
    BL: Severe Pain (n=985); Final Visit: Severe Pain
    6
    0.3%
    BL: Severe Pain (n=985); Final Visit: Missing
    243
    10.7%
    BL: Worst Poss. Pain (n=98); Final Vst: Mild Pain
    54
    2.4%
    BL: Worst Poss. Pain (n=98); Final Vst: Mod Pain
    25
    1.1%
    BL: Worst Poss. Pain (n=98); Final Visit: Sev Pain
    1
    0%
    BL: Worst Poss. Pain (n=98); Final Visit: Missing
    18
    0.8%
    BL: Missing (n=45); Final Visit: Mild Pain
    4
    0.2%
    BL: Missing (n=45); Final Visit: Moderate Pain
    1
    0%
    BL: Missing (n=45); Final Visit: Severe Pain
    1
    0%
    BL: Missing (n=45); Final Visit: Missing
    39
    1.7%
    5. Secondary Outcome
    Title Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    2nd Visit: Excellent (n=272); Final Vst: Excellent
    209
    9.2%
    2nd Visit: Excellent (n=272); Final Vst: Very Good
    6
    0.3%
    2nd Visit: Excellent (n=272); Final Visit: Good
    2
    0.1%
    2nd Visit: Excellent (n=272); Final Visit: Fair
    0
    0%
    2nd Visit: Excellent (n=272); Final Visit: Poor
    0
    0%
    2nd Visit: Excellent (n=272); Final Visit: Missing
    55
    2.4%
    2nd Visit: Very Good (n=803); Final Vst: Excellent
    307
    13.5%
    2nd Visit: Very Good (n=803); Final Vst: Very Good
    421
    18.5%
    2nd Visit: Very Good (n=803); Final Visit: Good
    10
    0.4%
    2nd Visit: Very Good (n=803); Final Visit: Fair
    0
    0%
    2nd Visit: Very Good (n=803); Final Visit: Poor
    0
    0%
    2nd Visit: Very Good (n=803); Final Visit: Missing
    65
    2.9%
    2nd Visit: Good (n=438); Final Visit: Excellent
    27
    1.2%
    2nd Visit: Good (n=438); Final Visit: Very Good
    267
    11.7%
    2nd Visit: Good (n=438); Final Visit: Good
    119
    5.2%
    2nd Visit: Good (n=438); Final Visit: Fair
    4
    0.2%
    2nd Visit: Good (n=438); Final Visit: Poor
    0
    0%
    2nd Visit: Good (n=438); Final Visit: Missing
    21
    0.9%
    2nd Visit: Fair (n=71); Final Visit: Excellent
    7
    0.3%
    2nd Visit: Fair (n=71); Final Visit: Very Good
    22
    1%
    2nd Visit: Fair (n=71); Final Visit: Good
    30
    1.3%
    2nd Visit: Fair (n=71); Final Visit: Fair
    3
    0.1%
    2nd Visit: Fair (n=71); Final Visit: Poor
    1
    0%
    2nd Visit: Fair (n=71); Final Visit: Missing
    8
    0.4%
    2nd Visit: Poor (n=7); Final Visit: Excellent
    0
    0%
    2nd Visit: Poor (n=7); Final Visit: Very Good
    1
    0%
    2nd Visit: Poor (n=7); Final Visit: Good
    2
    0.1%
    2nd Visit: Poor (n=7); Final Visit: Fair
    1
    0%
    2nd Visit: Poor (n=7); Final Visit: Poor
    1
    0%
    2nd Visit: Poor (n=7); Final Visit: Missing
    2
    0.1%
    2nd Visit: Missing (n=12); Final Visit: Excellent
    0
    0%
    2nd Visit: Missing (n=12); Final Visit: Very Good
    0
    0%
    2nd Visit: Missing (n=12); Final Visit: Good
    0
    0%
    2nd Visit: Missing (n=12); Final Visit: Fair
    0
    0%
    2nd Visit: Missing (n=12); Final Visit: Poor
    0
    0%
    2nd Visit: Missing (n=12); Final Visit: Missing
    12
    0.5%
    6. Secondary Outcome
    Title Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    2nd Visit: Excellent (n=260); Final Vst: Excell
    201
    8.8%
    2nd Visit: Excell (n=260) ; Final Vst:Very Good
    11
    0.5%
    2nd Visit: Excellent (n=260); Final Visit: Good
    1
    0%
    2nd Visit: Excellent (n=260) ; Final Visit: Fair
    0
    0%
    2nd Visit: Excellent (n=260) ; Final Visit: Poor
    0
    0%
    2nd Visit: Excellent (n=260); Final Visit: Missing
    47
    2.1%
    2nd Visit: Very Good (n=778); Final Visit: Excell
    297
    13%
    2nd Visit: Very Good (n=778); Final Vst: Very Good
    394
    17.3%
    2nd Visit: Very Good (n=778); Final Visit: Good
    13
    0.6%
    2nd Visit: Very Good (n=778); Final Visit: Fair
    1
    0%
    2nd Visit: Very Good (n=778); Final Visit: Poor
    0
    0%
    2nd Visit: Very Good (n=778); Final Visit: Missing
    73
    3.2%
    2nd Visit: Good (n=454); Final Visit: Excellent
    35
    1.5%
    2nd Visit: Good (n=454); Final Visit: Very Good
    263
    11.5%
    2nd Visit: Good (n=454); Final Visit: Good
    130
    5.7%
    2nd Visit: Good (n=454); Final Visit: Fair
    4
    0.2%
    2nd Visit: Good (n=454); Final Visit: Poor
    0
    0%
    2nd Visit: Good (n=454); Final Visit: Missing
    22
    1%
    2nd Visit: Fair (n=81); Final Visit: Excellent
    9
    0.4%
    2nd Visit: Fair (n=81); Final Visit: Very Good
    23
    1%
    2nd Visit: Fair (n=81); Final Visit:: Good
    31
    1.4%
    2nd Visit: Fair (n=81); Final Visit: Fair
    9
    0.4%
    2nd Visit: Fair (n=81); Final Visit: Poor
    1
    0%
    2nd Visit: Fair (n=81); Final Visit: Missing
    8
    0.4%
    2nd Visit: Poor (n=12); Final Visit: Excellent
    1
    0%
    2nd Visit: Poor (n=12); Final Visit: Very Good
    2
    0.1%
    2nd Visit: Poor (n=12); Final Visit: Good
    2
    0.1%
    2nd Visit: Poor (n=12); Final Visit: Fair
    2
    0.1%
    2nd Visit::Poor (n=12); Final Visit: Poor
    2
    0.1%
    2nd Visit: Poor (n=12); Final Visit: Missing
    3
    0.1%
    2nd Visit: Missing (n=18); Final Visit: Excellent
    0
    0%
    2nd Visit: Missing (n=18); Final Visit: Very Good
    2
    0.1%
    2nd Visit: Missing (n=18); Final Visit: Good
    0
    0%
    2nd Visit: Missing (n=18); Final Visit: Fair
    1
    0%
    2nd Visit: Missing (n=18); Final Visit: Poor
    0
    0%
    2nd Visit: Missing (n=18); Final Visit: Missing
    15
    0.7%
    7. Secondary Outcome
    Title Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    2nd Visit: Excellent (n=279); Final Visit: Excell
    217
    9.5%
    2nd Visit: Excellent (n=279); Final Vst: Very Good
    8
    0.4%
    2nd Visit: Excellent (n=279); Final Visit: Good
    1
    0%
    2nd Visit: Excellent (n=279); Final Visit: Fair
    0
    0%
    2nd Visit: Excellent (n=279); Final Visit: Poor
    0
    0%
    2nd Visit: Excellent (n=279); Final Visit: Missing
    53
    2.3%
    2nd Visit: Very Good (n=813); Final Visit: Excell
    298
    13.1%
    2nd Visit: Very Good (n=813); Final Vst: Very Good
    437
    19.2%
    2nd Visit: Very Good (n=813); Final Visit: Good
    10
    0.4%
    2nd Visit: Very Good (n=813); Final Visit: Fair
    0
    0%
    2nd Visit: Very Good (n=813); Final Visit: Poor
    0
    0%
    2nd Visit: Very Good (n=813); Final Visit: Missing
    68
    3%
    2nd Visit: Good (n=418); Final Visit: Excellent
    19
    0.8%
    2nd Visit: Good (n=418); Final Visit: Very Good
    258
    11.3%
    2nd Visit: Good (n=418); Final Visit: Good
    115
    5%
    2nd Visit: Good (n=418); Final Visit: Fair
    5
    0.2%
    2nd Visit: Good (n=418); Final Visit: Poor
    0
    0%
    2nd Visit: Good (n=418); Final Visit: Missing
    21
    0.9%
    2nd Visit: Fair (n=66); Final Visit: Excellent
    4
    0.2%
    2nd Visit: Fair (n=66); Final Visit: Very Good
    20
    0.9%
    2nd Visit: Fair (n=66); Final Visit: Good
    28
    1.2%
    2nd Visit: Fair (n=66); Final Visit: Fair
    5
    0.2%
    2nd Visit: Fair (n=66); Final Visit: Poor
    2
    0.1%
    2nd Visit: Fair (n=66); Final Visit: Missing
    7
    0.3%
    2nd Visit: Poor (n=7); Final Visit: Excellent
    0
    0%
    2nd Visit: Poor (n=7); Final Visit: Very Good
    2
    0.1%
    2nd Visit: Poor (n=7); Final Visit: Good
    2
    0.1%
    2nd Visit: Poor (n=7); Final Visit: Fair
    0
    0%
    2nd Visit: Poor (n=7); Final Visit: Poor
    1
    0%
    2nd Visit: Poor (n=7); Final Visit: Missing
    2
    0.1%
    2nd Visit: Missing (n=20); Final Visit: Excellent
    0
    0%
    2nd Visit: Missing (n=20); Final Visit: Very Good
    1
    0%
    2nd Visit: Missing (n=20); Final Visit: Good
    0
    0%
    2nd Visit: Missing (n=20); Final Visit: Fair
    0
    0%
    2nd Visit: Missing (n=20); Final Visit: Poor
    0
    0%
    2nd Visit: Missing (n=20); Final Visit: Missing
    19
    0.8%
    8. Secondary Outcome
    Title Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    2nd Visit: Excellent (n=264); Final Visit: Excell
    206
    9%
    2nd Visit: Excellent (n=264); Final Vst: Very Good
    8
    0.4%
    2nd Visit: Excellent (n=264); Final Visit: Good
    0
    0%
    2nd Visit: Excellent (n=264); Final Visit: Fair
    0
    0%
    2nd Visit: Excellent (n=264); Final Visit: Poor
    0
    0%
    2nd Visit: Excellent (n=264); Final Visit: Missing
    50
    2.2%
    2nd Visit: Very Good (n=775); Final Visit: Excell
    286
    12.6%
    2nd Visit: Very Good (n=775); Final Vst: Very Good
    405
    17.8%
    2nd Visit: Very Good (n=775); Final Visit: Good
    12
    0.5%
    2nd Visit: Very Good (n=775); Final Visit: Fair
    1
    0%
    2nd Visit: Very Good (n=775); Final Visit: Poor
    0
    0%
    2nd Visit: Very Good (n=775); Final Visit: Missing
    71
    3.1%
    2nd Visit: Good (n=450); Final Visit: Excellent
    34
    1.5%
    2nd Visit: Good (n=450): Final Visit: Very Good
    266
    11.7%
    2nd Visit: Good (n=450); Final Visit: Good
    127
    5.6%
    2nd Visit: Good (n=450); Final Visit: Fair
    1
    0%
    2nd Visit: Good (n=450); Final Visit: Poor
    0
    0%
    2nd Visit: Good (n=450); Final Visit: Missing
    22
    1%
    2nd Visit: Fair (n=75); Final Visit: Excellent
    6
    0.3%
    2nd Visit: Fair (n=75); Final Visit: Very Good
    21
    0.9%
    2nd Visit: Fair (n=75); Final Visit: Good
    32
    1.4%
    2nd Visit: Fair (n=75); Final Visit: Fair
    10
    0.4%
    2nd Visit: Fair (n=75); Final Visit: Poor
    0
    0%
    2nd Visit: Fair (n=75); Final Visit: Missing
    6
    0.3%
    2nd Visit: Poor (n=12); Final Visit: Excellent
    1
    0%
    2nd Visit :Poor (n=12); Final Visit: Very Good
    2
    0.1%
    2nd Visit: Poor (n=12); Final Visit: Good
    2
    0.1%
    2nd Visit: Poor (n=12); Final Visit: Fair
    0
    0%
    2nd Visit: Poor (n=12); Final Visit: Poor
    3
    0.1%
    2nd Visit: Poor (n=12); Final Visit: Missing
    4
    0.2%
    2nd Visit: Missing (n=27); Final Visit: Excellent
    0
    0%
    2nd Visit: Missing (n=27); Final Visit: Very Good
    3
    0.1%
    2nd Visit: Missing (n=27); Final Visit: Good
    0
    0%
    2nd Visit: Missing (n=27); Final Visit: Fair
    1
    0%
    2nd Visit: Missing (n=27); Final Visit: Poor
    0
    0%
    2nd Visit: Missing (n=27); Final Visit: Missing
    23
    1%
    9. Secondary Outcome
    Title Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    2nd Visit: Excellent (n=309); Final Visit: Excell
    237
    10.4%
    2nd Visit: Excellent (n=309); Final Vst: Very Good
    12
    0.5%
    2nd Visit: Excellent (n=309); Final Visit: Good
    0
    0%
    2nd Visit: Excellent (n=309); Final Visit: Fair
    0
    0%
    2nd Visit: Excellent (n=309); Final Visit: Poor
    0
    0%
    2nd Visit: Excellent (n=309); Final Visit: Missing
    60
    2.6%
    2nd Visit: Very Good (n=764); Final Visit: Excell
    255
    11.2%
    2nd Visit: Very Good (n=764); Final Vst:Very Good
    431
    18.9%
    2nd Visit: Very Good (n=764); Final Visit: Good
    9
    0.4%
    2nd Visit: Very Good (n=764); Final Visit: Fair
    1
    0%
    2nd Visit: Very Good (n=764); Final Visit: Poor
    1
    0%
    2nd Visit: Very Good (n=764); Final Visit: Missing
    67
    2.9%
    2nd Visit: Good (n=436); Final Visit: Excellent
    24
    1.1%
    2nd Visit: Good (n=436); Final Visit: Very Good
    254
    11.2%
    2nd Visit: Good (n=436); Final Visit: Good
    135
    5.9%
    2nd Visit: Good (n=436); Final Visit: Fair
    1
    0%
    2nd Visit: Good (n=436); Final Visit: Poor
    1
    0%
    2nd Visit: Good (n=436); Final Visit: Missing
    21
    0.9%
    2nd Visit: Fair (n=67); Final Visit: Excellent
    6
    0.3%
    2nd Visit: Fair (n=67); Final Visit: Very Good
    19
    0.8%
    2nd Visit: Fair (n=67); Final Visit: Good
    30
    1.3%
    2nd Visit: Fair (n=67); Final Visit: Fair
    5
    0.2%
    2nd Visit: Fair (n=67); Final Visit: Poor
    1
    0%
    2nd Visit: Fair (n=67); Final Visit: Missing
    6
    0.3%
    2nd Visit: Poor (n=6); Final Visit: Excellent
    1
    0%
    2nd Visit: Poor (n=6); Final Visit: Very Good
    0
    0%
    2nd Visit: Poor (n=6); Final Visit: Good
    1
    0%
    2nd Visit: Poor (n=6); Final Visit: Fair
    0
    0%
    2nd Visit: Poor (n=6); Final Visit: Poor
    3
    0.1%
    2nd Visit: Poor (n=6); Final Visit: Missing
    1
    0%
    2nd Visit: Missing (n=21); Final Visit: Excellent
    1
    0%
    2nd Visit: Missing (n=21); Final Visit: Very Good
    2
    0.1%
    2nd Visit: Missing (n=21); Final Visit: Good
    0
    0%
    2nd Visit: Missing (n=21); Final Visit: Fair
    0
    0%
    2nd Visit: Missing (n=21); Final Visit: Poor
    0
    0%
    2nd Visit: Missing (n=21); Final Visit: Missing
    18
    0.8%
    10. Secondary Outcome
    Title Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 1603
    2nd Visit: Excellent (n=278); Final Visit: Excell
    213
    9.4%
    2nd Visit: Excellent (n=278); Final Vst: Very Good
    14
    0.6%
    2nd Visit: Excellent (n=278); Final Visit: Good
    0
    0%
    2nd Visit: Excellent (n=278); Final Visit: Fair
    0
    0%
    2nd Visit: Excellent (n=278); Final Visit: Poor
    0
    0%
    2nd Visit: Excellent (n=278); Final Visit: Missing
    51
    2.2%
    2nd Visit: Very Good (n=750); Final Visit: Excell
    257
    11.3%
    2nd Visit: Very Good (n=750); Final Vst: Very Good
    415
    18.2%
    2nd Visit: Very Good (n=750); Final Visit: Good
    13
    0.6%
    2nd Visit: Very Good (n=750); Final Visit: Fair
    1
    0%
    2nd Visit: Very Good (n=750); Final Visit: Poor
    0
    0%
    2nd Visit: Very Good (n=750); Final Visit: Missing
    64
    2.8%
    2nd Visit: Good (n=465); Final Visit: Excellent
    27
    1.2%
    2nd Visit: Good (n=465); Final Visit: Very Good
    255
    11.2%
    2nd Visit: Good (n=465); Final Visit: Good
    151
    6.6%
    2nd Visit: Good (n=465); Final Visit: Fair
    4
    0.2%
    2nd Visit: Good (n=465); Final Visit: Poor
    2
    0.1%
    2nd Visit: Good (n=465); Final Visit: Missing
    26
    1.1%
    2nd Visit: Fair (n=71); Final Visit: Excellent
    8
    0.4%
    2nd Visit: Fair (n=71); Final Visit: Very Good
    18
    0.8%
    2nd Visit: Fair (n=71); Final Visit: Good
    31
    1.4%
    2nd Visit: Fair (n=71); Final Visit: Fair
    7
    0.3%
    2nd Visit: Fair (n=71); Final Visit: Poor
    1
    0%
    2nd Visit: Fair (n=71); Final Visit: Missing
    6
    0.3%
    2nd Visit: Poor (n=11); Final Visit: Excellent
    1
    0%
    2nd Visit: Poor (n=11); Final Visit: Very Good
    2
    0.1%
    2nd Visit: Poor (n=11); Final Visit: Good
    1
    0%
    2nd Visit: Poor (n=11); Final Visit: Fair
    0
    0%
    2nd Visit: Poor (n=11); Final Visit: Poor
    3
    0.1%
    2nd Visit: Poor (n=11); Final Visit: Missing
    4
    0.2%
    2nd Visit: Missing (n=28); Final Visit: Excellent
    1
    0%
    2nd Visit: Missing (n=28); Final Visit: Very Good
    2
    0.1%
    2nd Visit: Missing (n=28); Final Visit: Good
    0
    0%
    2nd Visit: Missing (n=28); Final Visit: Fair
    1
    0%
    2nd Visit: Missing (n=28); Final Visit: Poor
    0
    0%
    2nd Visit: Missing (n=28); Final Visit: Missing
    24
    1.1%
    11. Primary Outcome
    Title Discontinuations Due to Adverse Events
    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)

    Outcome Measure Data

    Analysis Population Description
    Safety population: all subjects who took at least one dose of study medication.
    Arm/Group Title Pregabalin
    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.
    Measure Participants 2278
    Cardiac Disorders: palpitations
    1
    0%
    Ear and Labyrinth Disorders: vertigo
    1
    0%
    Gastrointestinal Disorders: nausea
    5
    0.2%
    Gastrointestinal Disorders: vomiting
    3
    0.1%
    General/ Administrative Site Conditions: asthenia
    2
    0.1%
    Nervous System Disorders: somnolence
    26
    1.1%
    Resp., Thoracic & Mediastinal Disorders: snoring
    1
    0%
    Vascular Disorders: hypertension
    1
    0%

    Adverse Events

    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
    Arm/Group Title Pregabalin
    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 (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Pregabalin
    Affected / at Risk (%) # Events
    Total 7/2278 (0.3%)
    General disorders
    Asthenia 1/2278 (0%)
    Multi-organ failure 1/2278 (0%)
    Infections and infestations
    Bronchopneumonia 1/2278 (0%)
    Pneumonia 1/2278 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer stage III 1/2278 (0%)
    Metastases to central nervous system 1/2278 (0%)
    Metastatic neoplasm 1/2278 (0%)
    Nervous system disorders
    Dizziness 1/2278 (0%)
    Neuralgia 1/2278 (0%)
    Sedation 1/2278 (0%)
    Somnolence 1/2278 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/2278 (0%)
    Other (Not Including Serious) Adverse Events
    Pregabalin
    Affected / at Risk (%) # Events
    Total 345/2278 (15.1%)
    Cardiac disorders
    Palpitations 1/2278 (0%)
    Ear and labyrinth disorders
    Ear disorder 1/2278 (0%)
    Vertigo 2/2278 (0.1%)
    Gastrointestinal disorders
    Abdominal discomfort 1/2278 (0%)
    Abdominal distension 1/2278 (0%)
    Abdominal pain upper 1/2278 (0%)
    Constipation 2/2278 (0.1%)
    Diarrhoea 2/2278 (0.1%)
    Dry mouth 6/2278 (0.3%)
    Dyspepsia 1/2278 (0%)
    Epigastric discomfort 1/2278 (0%)
    Nausea 27/2278 (1.2%)
    Vomiting 13/2278 (0.6%)
    General disorders
    Asthenia 4/2278 (0.2%)
    Fatigue 2/2278 (0.1%)
    Ill-defined disorder 8/2278 (0.4%)
    Irritability 3/2278 (0.1%)
    Oedema peripheral 2/2278 (0.1%)
    Pyrexia 2/2278 (0.1%)
    Hepatobiliary disorders
    Jaundice 1/2278 (0%)
    Investigations
    Weight increased 1/2278 (0%)
    Metabolism and nutrition disorders
    Anorexia 1/2278 (0%)
    Hypoglycaemia 1/2278 (0%)
    Increased appetite 1/2278 (0%)
    Musculoskeletal and connective tissue disorders
    Muscular weakness 1/2278 (0%)
    Myalgia 1/2278 (0%)
    Nervous system disorders
    Balance disorder 1/2278 (0%)
    Dizziness 135/2278 (5.9%)
    Headache 4/2278 (0.2%)
    Hypersomnia 7/2278 (0.3%)
    Incoherent 1/2278 (0%)
    Paraesthesia 1/2278 (0%)
    Sedation 4/2278 (0.2%)
    Somnolence 92/2278 (4%)
    Syncope 2/2278 (0.1%)
    Tremor 1/2278 (0%)
    Psychiatric disorders
    Abnormal dreams 1/2278 (0%)
    Confusional state 1/2278 (0%)
    Insomnia 1/2278 (0%)
    Reproductive system and breast disorders
    Ejaculation disorder 1/2278 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional 1/2278 (0%)
    Snoring 1/2278 (0%)
    Skin and subcutaneous tissue disorders
    Rash generalized 1/2278 (0%)
    Vascular disorders
    Hypertension 1/2278 (0%)
    Hypotension 1/2278 (0%)
    Pallor 1/2278 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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
    Email ClinicalTrials.govCallCenter@pfizer.com
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT00892008
    Other Study ID Numbers:
    • A0081094
    First Posted:
    May 1, 2009
    Last Update Posted:
    Jan 25, 2021
    Last Verified:
    Jan 1, 2010