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Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

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: NCT00468845
Recruitment Status : Completed
First Posted : May 3, 2007
Results First Posted : May 26, 2011
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE May 1, 2007
First Posted Date  ICMJE May 3, 2007
Results First Submitted Date  ICMJE April 29, 2011
Results First Posted Date  ICMJE May 26, 2011
Last Update Posted Date February 10, 2021
Study Start Date  ICMJE June 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) [ Time Frame: Day 2 (24 hours post surgery [PS]) ]
Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2007)
The primary endpoint is the pain reported by subjects, using the Worst pain Numerical Rating Scale on first day after the surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
  • Current Pain - Pain With Movement Caused by Sitting [ Time Frame: Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS ]
    Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test [ Time Frame: Day 1, up to 7 days PS, 2 and 4 weeks PS ]
    Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting [ Time Frame: 48 +/- 4 hours PS ]
    Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test [ Time Frame: 48 +/- 4 hours PS ]
    Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Current Pain at Rest [ Time Frame: 8, 16, 24, 32, 40, 48 hours PS ]
    Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay [ Time Frame: 48 +/- 4 hours PS ]
    Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Total Cumulative Dose of Opioids Following Surgery [ Time Frame: 24, 48 Hours PS, Discharge (day 3 up to day 7 PS) ]
    Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Integrated Analgesic Score [ Time Frame: 0-24, 24-48, 48-72 hours PS ]
    The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Non-opioid Rescue Medication - Paracetamol [ Time Frame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS, ]
    The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.
  • Anxiety Before and After Surgery [ Time Frame: Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS) ]
    Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata
  • Non-opioid Rescue Medication - Ibuprofen [ Time Frame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS ]
    The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.
  • Percent Change From Baseline in Peak Expiratory Flow [ Time Frame: Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible) ]
    Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Timed Up-and-Go (TUG) [ Time Frame: Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS) ]
    Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Average Daily Pain [ Time Frame: Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS ]
    Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Worst Daily Pain [ Time Frame: Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS ]
    Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.
  • Sleep Interference [ Time Frame: Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS ]
    Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores [ Time Frame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS ]
    m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores [ Time Frame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS ]
    m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Participant Satisfaction With Study Medication - Surgery Day [ Time Frame: Day 1 ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 1 PS [ Time Frame: Day 1 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 2 PS [ Time Frame: Day 2 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 3 PS [ Time Frame: Day 3 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 4 PS [ Time Frame: Day 4 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 5 PS [ Time Frame: Day 5 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Discharge [ Time Frame: Discharge (day 3 up to day 7 PS) ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 7 PS [ Time Frame: Day 7 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 14 PS [ Time Frame: Day 14 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Participant Satisfaction With Study Medication - Day 28 PS [ Time Frame: Day 28 PS ]
    Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
  • Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication [ Time Frame: Discharge (day 3 up to day 7 PS), Day 28 PS ]
    Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication [ Time Frame: Discharge (day 3 up to day 7 PS), Day 28 PS ]
    Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
  • Quality of Life Using EuroQol (EQ-5D) Health State Profile [ Time Frame: Discharge (day 3 up to day 7 PS) and day 28 PS ]
    Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, "confined to bed"). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata.
  • Time to Meet Hospital Discharge Criteria [ Time Frame: Day 1 up to Day 7 PS ]
    Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.
  • Time to Actual Discharge [ Time Frame: Day 1 up to Day 7 PS ]
    Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.
  • Incidence of Chronic Post-operative Pain [ Time Frame: 3 and 6 Months PS ]
    Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.
  • Total Clinically Meaningful Event (CME) Score [ Time Frame: Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS ]
    Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2007)
  • The pain reported by the subjects with movement (NRS Current Pain) at each assessment time during the hospital stay and the area under the curve (AUC) of pain reported by the subjects with movement during the hospital stay.
  • There are separate secondary endpoints for pain with movement caused by sitting and for pain with movement caused by the peak expiratory flow (PEF) test.
  • The amounts of opioids used following surgery. The total cumulative dose will be calculated as mg of morphine equivalent and will include opioids administered by any route (PCA pump, parenteral bolus, or oral). [ Time Frame: It will be evaluated at 24 hours, 48 hours, time of discharge from the hospital, and time of the Begin Taper visit. ]
  • A total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS).
  • The pain reported by the subjects at rest (NRS Current Pain) at each assessment time during the hospital stay and the area under the curve (AUC) of pain reported by the subjects at rest during the hospital stay.
  • The integrated analgesic score (a combination of opioid use and resting pain as defined by Silverman et al 1993).
  • The amounts of non-opioid rescue medications used by the subjects during the study, including anti-emetic medications.
  • The percentage of baseline peak expiratory flow (PEF) measured at each post-operative assessment time.
  • Functional mobility after surgery as measured by the timed up and go (TUG) test.
  • Time from the end of surgery, in hours, to meet protocol-defined hospital discharge criteria as well as the time to actual hospital discharge.
  • Anxiety (VAS) before and after the surgery.
  • Post-discharge average and worst pain severity measured in daily subject diaries (NRS - Average Pain, NRS - Worst Pain).
  • Sleep interference post surgery measured in daily subject diaries (NRS Sleep).
  • Interference of pain with aspects of daily activities measured using the Modified Brief Pain Inventory Short Form (mBPI-sf).
  • Subject satisfaction with study medication with the Global Evaluation of Study Medication.
  • Subject satisfaction with pain treatment using the Pain Treatment Satisfaction Scale (PTSS).
  • Quality of life using EuroQol (EQ-5D) Health State Profile.
  • Incidence of chronic post-operative pain at 3 and 6 months following surgery and the characteristics of the pain in those subjects reporting it (mBPI-sf, NPSI).
  • All serious adverse events (SAEs), all treatment-emergent adverse events (AEs).
  • Prespecified adverse events of wound healing complications.
  • Vital signs and clinical laboratory parameters.
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2011)
  • Percentage of Participants With Wound Healing Complications - Discharge [ Time Frame: Discharge (day 3 up to day 7 PS) ]
    Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
  • Percentage of Participants With Wound Healing Complications - Day 7 PS [ Time Frame: Day 7 PS ]
    Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
  • Percentage of Participants With Wound Healing Complications - Day 14 PS [ Time Frame: Day 14 PS ]
    Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
  • Percentage of Participants With Wound Healing Complications - Day 28 PS [ Time Frame: Day 28 PS ]
    Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
  • Percentage of Participants With Wound Healing Complications - End of Treatment [ Time Frame: Day 1 up to Day 28 PS ]
    Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
  • Incision Length Correlated With Worst Pain [ Time Frame: Day 1 ]
    Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Discharge (day 3 up to day 7 PS) ]
    Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Official Title  ICMJE A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy
Brief Summary To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: pregabalin (Lyrica)
    150 mg/day double blind (divided doses)
  • Drug: pregabalin (Lyrica)
    300 mg/day double blind (divided doses)
  • Drug: matched placebo
    matched placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin (Lyrica)
  • Experimental: 2
    Intervention: Drug: pregabalin (Lyrica)
  • Placebo Comparator: 3
    Intervention: Drug: matched placebo
Publications * Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2010)
501
Original Enrollment  ICMJE
 (submitted: May 1, 2007)
300
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
  • The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
  • The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.

Exclusion Criteria:

  • Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
  • Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
  • The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
  • Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
  • The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Hong Kong,   South Africa,   Spain,   Sweden,   Thailand,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00468845
Other Study ID Numbers  ICMJE A0081153
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP