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Trial record 1 of 1 for:    NCT00892008
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A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin (PAINS)

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ClinicalTrials.gov Identifier: NCT00892008
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : November 18, 2009
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date April 30, 2009
First Posted Date May 1, 2009
Results First Submitted Date August 27, 2009
Results First Posted Date November 18, 2009
Last Update Posted Date January 25, 2021
Study Start Date September 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2010)
  • Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) [ Time Frame: Baseline through Final Visit (Week 4) ]
    Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.
  • Discontinuations Due to Adverse Events [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Discontinuations due to adverse events by MedDRA system organ class and preferred term.
Original Primary Outcome Measures
 (submitted: April 30, 2009)
Safety and tolerability of pregabalin in the treatment of patients with wide variety of neuropathic pain syndromes based on incidence of adverse events. [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: January 8, 2010)
  • Change From Baseline in Visual Analogue Scale (VAS) Score [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.
  • VAS Pain Score at Baseline (BL) and Second Visit [ Time Frame: Baseline, Second Visit (Week ≥ 2) ]
    VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .
  • VAS Pain Score at Baseline and Final Visit [ Time Frame: Baseline, Final Visit (Week 4) ]
    VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.
  • Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
  • Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
  • Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
  • Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
  • Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
  • Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
    Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.
Original Secondary Outcome Measures
 (submitted: April 30, 2009)
Efficacy of pregabalin in the treatment of patients with neuropathic pain based on Visual Analogue Scale [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
Official Title Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male or female, 18 years and above diagnosed with neuropathic pain.
Condition Neuropathic Pain
Intervention Drug: Pregabalin
Pregabalin 75-150 mg BID for at least 2 weeks.
Other Name: Lyrica
Study Groups/Cohorts Open-Label
This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.
Intervention: Drug: Pregabalin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 9, 2009)
2278
Original Actual Enrollment
 (submitted: April 30, 2009)
3000
Actual Study Completion Date August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00892008
Other Study ID Numbers A0081094
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010