Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT00507026
- Lead Sponsor
- Pfizer
- Brief Summary
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.
- Detailed Description
The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
- Scheduled within three weeks of the screening visit to undergo elective orthopedic surgery.
- Moderate to severe pain within 6 hours following completion of the required surgery.
- Chronic pain conditions.
- Chronic disease or recent cardiovascular events.
- Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A IV Diclofenac DIC075V (IV diclofenac) B IV ketorolac IV Ketorolac C Placebo Placebo
- Primary Outcome Measures
Name Time Method Sum of the Pain Intensity Differences (SPID) Over 72 Hours Over 72 hours post first dose Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 72 hours ranges from -7200 to 7200. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 96 Hours Over 96 hours post first dose Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 96 hours ranges from -9600 to 9600. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 24 Hours Over 24 hours post first dose Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 24 hours ranges from -2400 to 2400. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 48 Hours Over 48 hours post first dose Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 48 hours ranges from -4800 to 4800. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 120 Hours Over 120 hours post first dose Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 120 hours ranges from -12000 to 12000. A higher value indicates a better pain reduction.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose Pain intensity was measured on a 0 to 100 mm VAS, larger values indicate greater pain intensity. In this outcome measure, percentage of participants attaining \>= 30 % reduction in pain intensity from baseline to specified time points was reported.
Total Pain Relief (TOTPAR) 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. TOTPAR over specified time interval was calculated as area under pain relief curve over specified time intervals using trapezoidal approximation. For 0-24 hours score range was 0-2400, for 0-48 hours score range was 0- 4800, for 0-96 hours score range was 0-9600 and for 0-120 hours score range was 0-12000. Higher TOTPAR values indicated more relief.
Participant Global Evaluation Over Time 0-24, 0-48, 0-120 hours post-dose Participants global evaluation of study medication was accessed on a scale ranging from scale 0 to 4 where 0= poor, 1= fair, 2= good, 3= very good, 4= excellent where higher score represented better outcome.
Pain Intensity Differences (PID) Over Time Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). PID score range at any post dose (post baseline) evaluation time point was -100 to 100. A positive difference score is indicative of improvement.
Visual Analog Pain Relief Values Over the Time 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief.
Time From Administration of Study Drug to Administration of Rescue Medication Maximum up to 5 days Time from administration of study drug to administration of rescue medication were censored at time of last pain assessment for participants who did not receive rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine.
Number of Participants According to Frequency of Use of Rescue Medication 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose In this outcome measure, number of participants are reported according to number of times they received rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. Only those categories with at least one nonzero value are reported.
Cumulative Amount of Rescue Medication 0-24, 0-48, 0-72, 0-96 and 0-120 hours In this outcome measure, cumulative amount of rescue medication used over 0-24, 0-48, 0-72, 0-96, and 0-120 hours were reported. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine.
Time to Perceptible Relief Within 6 hours of first dose on Day 1 Participants were instructed to stop the first stopwatch at the onset of perceptible pain relief after first dose. Event times of participants not reporting perceptible relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis.
Time to Meaningful Relief Within 6 hours of first dose on Day 1 Participants were instructed to stop the second stopwatch at the onset of meaningful pain relief after first dose. Event times of participants not reporting meaningful relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis.
Trial Locations
- Locations (8)
American Institute of Healthcare and Fitness
🇺🇸Raleigh, North Carolina, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
SCIREX
🇺🇸Austin, Texas, United States
Helen Keller Hospital
🇺🇸Sheffield, Alabama, United States
Accurate Clinical Trials
🇺🇸San Clemente, California, United States
Outcomes Research Institute
🇺🇸Louisville, Kentucky, United States
East Coast Clincial Research
🇺🇸Fort Pierce, Florida, United States