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Trial record 66 of 424 for:    Pregabalin

Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement

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ClinicalTrials.gov Identifier: NCT00729690
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition PAIN
Interventions Drug: Pregabalin
Drug: Placebo
Enrollment 48
Recruitment Details Forty-eight patients scheduled to undergo elective primary Total Knee Replacement (TKR) for osteoarthritis by 2 orthopedic surgeons were recruited at the Rush University Medical Center (Chicago, Illinois).
Pre-assignment Details  
Arm/Group Title 1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Hide Arm/Group Description Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose. Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose. Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
Period Title: Overall Study
Started 16 16 16
Completed 16 14 14
Not Completed 0 2 2
Reason Not Completed
IT Catheter Malfunction             0             2             2
Arm/Group Title 1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo Total
Hide Arm/Group Description Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose. Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose. Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.) Total of all reporting groups
Overall Number of Baseline Participants 16 16 16 48
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 16 participants 48 participants
66.9  (6.4) 64.8  (4.4) 66.4  (4.5) 66.1  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 16 participants 48 participants
Female
12
  75.0%
9
  56.3%
13
  81.3%
34
  70.8%
Male
4
  25.0%
7
  43.8%
3
  18.8%
14
  29.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 16 participants 48 participants
16 16 16 48
1.Primary Outcome
Title NRS Pain Score AUC (NRS*hr) - 1st 24 Hours
Hide Description Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All Completed Patients were included in the analysis.
Arm/Group Title 1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Hide Arm/Group Description:
Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
Overall Number of Participants Analyzed 16 14 14
Mean (Standard Deviation)
Unit of Measure: Area (NRS*hr)
70.4  (34.4) 59.6  (31.1) 73.4  (34.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Multi-Dose Pregabalin, 2 Single-dose Pregabalin, 3 Placebo
Comments For 1st 24 hours NRS AUC Pain scores
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4742
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title NRS Pain Score AUC (NRS*hr) - 1st 12 Hours
Hide Description Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.
Time Frame 12 hours Post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All Completed Patients
Arm/Group Title 1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Hide Arm/Group Description:
Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
Overall Number of Participants Analyzed 16 14 14
Mean (Standard Deviation)
Unit of Measure: Area (NRS*hr)
30.1  (15.6) 22.7  (16.9) 27.7  (16.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Multi-Dose Pregabalin, 2 Single-dose Pregabalin, 3 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4321
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Active Knee Flexion
Hide Description The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2
Time Frame PostOp day 2
Hide Outcome Measure Data
Hide Analysis Population Description
All completed patients used.
Arm/Group Title 1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Hide Arm/Group Description:
Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
Overall Number of Participants Analyzed 16 14 14
Mean (Standard Deviation)
Unit of Measure: Degrees
78.1  (10.6) 80.5  (10.1) 80.5  (7.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Multi-Dose Pregabalin, 2 Single-dose Pregabalin, 3 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7596
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Passive Knee Flexion
Hide Description Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion).
Time Frame PostOp day 2
Hide Outcome Measure Data
Hide Analysis Population Description
All Completed Patients were used
Arm/Group Title 1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Hide Arm/Group Description:
Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
Overall Number of Participants Analyzed 16 14 14
Mean (Standard Deviation)
Unit of Measure: Degrees
86.5  (15.3) 88.2  (9.44) 87.1  (10.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Multi-Dose Pregabalin, 2 Single-dose Pregabalin, 3 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9361
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Hide Arm/Group Description Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose. Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose. Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
All-Cause Mortality
1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 Multi-Dose Pregabalin 2 Single-dose Pregabalin 3 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      3/16 (18.75%)      7/16 (43.75%)    
Skin and subcutaneous tissue disorders       
Pruritus   2/16 (12.50%)  2 3/16 (18.75%)  3 7/16 (43.75%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Asokumar Buvanendran
Organization: Rush University
Phone: (312) 942-3685
Responsible Party: Asokumar Buvanendran, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00729690     History of Changes
Other Study ID Numbers: 08021105
First Submitted: August 5, 2008
First Posted: August 7, 2008
Results First Submitted: October 18, 2012
Results First Posted: December 19, 2012
Last Update Posted: December 19, 2012