NCT00442546
Completed
Phase 3
A Multicenter, Double-Blind Randomized, Placebo-Controlled Study Of The Efficacy And Safety Of Pregabalin In The Treatment Of Subjects With Post-Operative Pain Following Total Knee Arthroplasty (TKA)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country307 target enrollmentStarted: May 2007Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 307
- Locations
- 1
- Primary Endpoint
- Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Overview
Brief Summary
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block).
- •Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care.
- •The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3
Exclusion Criteria
- •Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure.
- •Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease.
- •Subjects with fibromyalgia and or other chronic pain syndromes
Arms & Interventions
2
Experimental
Intervention: pregabalin (Drug)
3
Placebo Comparator
Intervention: Placebo (Drug)
1
Experimental
Intervention: pregabalin (Drug)
Outcomes
Primary Outcomes
Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Time Frame: 48 hours after surgery
The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), subjects were asked to rate their pain by marking an "X" in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block.
Secondary Outcomes
- Cumulative Total Amount of Opioids Used During the Entire Hospital Stay(24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours)
- Pain Interference Index Score as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Pain Interference With Relations With People as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Pain Interference With General Activity as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Opioids Used Post Discharge(Week 2, Week 4, Week 6/Early Termination (ET))
- Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)(24 hours, 48 hours, 72 hours)
- Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6](Week 2, Week 4, Week 6/ET)
- Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups(Week 2, Week 4, Week 6/ET)
- Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group(Week 2, Week 4, Week 6/ET)
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4(Week 4)
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4(Week 4)
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET(Week 6/ET)
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET(Week 6/ET)
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score(24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET)
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score(24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET)
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score(24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET)
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score(24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET)
- Total Clinically Meaningful Event (CME) Score(24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET)
- Pain Interference With Mood as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Pain Interference With Walking Ability as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Pain Interference With Normal Work as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Pain Interference With Sleep as Measured by the m-BPI-sf(Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6)
- Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)(12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET)
- Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS(12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET)
- Current Pain During the Hospital Stay Assessed by the Pain NRS(4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay)
- Pain-Related Sleep Interference Post Surgery(24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET)
- Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery(Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery)
- Timed Up-and-Go (TUG)(24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET)
- Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee(24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET)
- ROM Assessment of the Passive Flexion of the Surgical Knee(24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET)
- Time From End of Surgery to Meet Hospital Discharge Criteria(time from end of surgery up to 192 hours post surgery)
- Time From End of Surgery to Actual Discharge(time from end of surgery up to 192 hours post surgery)
- Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)(Discharge, Week 2, Week 4, Week 6/ET)
- Satisfaction With Medication Characteristics Measured by the PTSS(Discharge, Week 2, Week 4, Week 6/ET)
- Satisfaction With Medication Efficacy Measured by the PTSS(Discharge, Week 2, Week 4, Week 6/ET)
- Overall Satisfaction Measured by the PTSS(Discharge, Week 2, Week 4, and Week 6/ET)
- Overall Pain Relief Measured by the PTSS(Discharge, Week 2, Week 4, and Week 6/ET)
- Number of Subjects With Global Evaluation of Study Medication Scores(Discharge, Week 2, Week 4, and Week 6/ET)
- Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)(Month 3, Month 6 (phone call))
- Neuropathic Pain Symptom Inventory (NPSI)(Month 3, Month 6 (phone call))
Investigators
Study Sites (1)
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