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Trial record 1 of 1 for:    NCT00905437
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Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT00905437
Recruitment Status : Terminated (The Study was terminated on May 24th 2012 due to a slow recruitment rate. The study was not terminated for reasons of safety or efficacy.)
First Posted : May 20, 2009
Results First Posted : June 11, 2013
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 19, 2009
First Posted Date  ICMJE May 20, 2009
Results First Submitted Date  ICMJE April 25, 2013
Results First Posted Date  ICMJE June 11, 2013
Last Update Posted Date June 11, 2013
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
Mean Pain on Movement Score [ Time Frame: Every 12 hours from Day 1 to Day 5 post-surgery ]
Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
Mean of the Pain on Movement scores obtained over Post-Op Days 1-5. The Pain on Movement assessments are performed using an 11-point Numeric Rating Scale [NRS] following passive flexion & adduction at hip joint at 12-hr interval intervals [ Time Frame: 5 days ]
Change History Complete list of historical versions of study NCT00905437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
  • Mean Daily Pain Score [ Time Frame: Day 1 to Day 7, Day 8 to Day 14 post-surgery ]
    Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
  • Mean Daily Sleep Interference Score [ Time Frame: Day 1 to Day 5 post-surgery ]
    Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
  • Mean Anxiety Visual Analogue Scale (A-VAS) [ Time Frame: Day 0 to Day 5 post-surgery ]
    Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious.
  • Time to Mobilization After Surgery [ Time Frame: Day 1 to Day 5 post-surgery ]
    Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization.
  • Number of Participants With Rescue Medication Usage [ Time Frame: Day 0 to Day 6 post-surgery ]
    Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications.
  • Number of Participants With Neuropathic Pain [ Time Frame: Day 90, Day 180 post-surgery ]
    ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. "Yes" response to questions 1-5 were scored as 1, while a "yes" response to question 6 was scored as -1. "No" response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
  • Mean of the Daily Pain Scores (11-point NRS) obtained on Post-Op Days 1-7, and mean of the Daily Pain Scores obtained on Post-Op Days 8-14 [ Time Frame: 14 days ]
  • Mean of the Daily Sleep Interference Scores (11-point NRS) obtained on Post-Op Days 1-5 [ Time Frame: 5 days ]
  • Mean of the Anxiety Visual Analog Scale (A-VAS) scores obtained from the assessment performed on the day of surgery through to Post-Op Day 5 [ Time Frame: 5 days ]
  • Time to mobilization (day on which patient is able to walk 5 steps for the first time post-surgery) [ Time Frame: 5 days ]
  • Use of rescue analgesics administered on Post-Op Days 0 - 5 [ Time Frame: 5days ]
  • Incidence of neuropathic pain as detected using the ID Pain questionnaire 3 & 6 months following the surgery [ Time Frame: 6 mths ]
  • Safety & tolerability of pregabalin versus placebo in patients undergoing primary total hip arthroplasty [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
Official Title  ICMJE Randomized Double-Blind, Multi-Center Study Of Efficacy And Tolerability Of Pregabalin Versus Placebo As An Adjunct To Standard Of Care For Perioperative Management Of Patients Undergoing Total Hip Arthroplasty
Brief Summary The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pain, Perioperative
Intervention  ICMJE
  • Drug: Placebo
    Placebo as an adjunct to standard of care
  • Drug: Pregabalin
    75 mg BD for 14 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo as an adjunct to standard of care
    Intervention: Drug: Placebo
  • Active Comparator: Pregabalin
    Pregabalin as an adjunct to standard of care
    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  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 4, 2012)
72
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2009)
256
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia

Exclusion Criteria:

  • The patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, or a procedure expected to last longer than 4 hours
  • The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00905437
Other Study ID Numbers  ICMJE A0081229
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2013

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