- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00507026
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
September 29, 2021 updated by: Pfizer
Randomized, Double-Blind, Active-and Placebo-Controlled Study of the Analgesic Efficacy and Safety of Repeated Dosing of DIC075V Versus Parenteral Ketorolac and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
277
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Sheffield, Alabama, United States, 35660
- Helen Keller Hospital
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Arizona
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Phoenix, Arizona, United States, 85023
- Arizona Research Center
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California
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San Clemente, California, United States, 92672
- Accurate Clinical Trials
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Florida
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Fort Pierce, Florida, United States, 34950
- East Coast Clincial Research
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Kentucky
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Louisville, Kentucky, United States, 40202
- Outcomes Research Institute
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North Carolina
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Raleigh, North Carolina, United States, 27615
- American Institute of Healthcare and Fitness
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Pennsylvania
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State College, Pennsylvania, United States, 16081
- University Orthopedics Center
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Texas
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Austin, Texas, United States, 78705
- SCIREX
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: C
Placebo
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Placebo q6h
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Experimental: A
DIC075V (IV diclofenac)
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IV Diclofenac q6h
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Active Comparator: B
IV Ketorolac
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IV ketorolac q6h
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sum of the Pain Intensity Differences (SPID) Over 24 Hours
Time Frame: 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.
|
Over 24 hours post first dose
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Sum of the Pain Intensity Differences (SPID) Over 48 Hours
Time Frame: 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.
|
Over 48 hours post first dose
|
Sum of the Pain Intensity Differences (SPID) Over 72 Hours
Time Frame: 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.
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Over 72 hours post first dose
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Sum of the Pain Intensity Differences (SPID) Over 96 Hours
Time Frame: 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.
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Over 96 hours post first dose
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Sum of the Pain Intensity Differences (SPID) Over 120 Hours
Time Frame: 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.
|
Over 120 hours post first dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity Differences (PID) Over Time
Time Frame: 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.
|
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
|
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity
Time Frame: Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose
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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.
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Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose
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Total Pain Relief (TOTPAR)
Time Frame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
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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.
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0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
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Visual Analog Pain Relief Values Over the Time
Time Frame: 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
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Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief.
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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
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Time From Administration of Study Drug to Administration of Rescue Medication
Time Frame: Maximum up to 5 days
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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.
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Maximum up to 5 days
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Cumulative Amount of Rescue Medication
Time Frame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours
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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.
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0-24, 0-48, 0-72, 0-96 and 0-120 hours
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Number of Participants According to Frequency of Use of Rescue Medication
Time Frame: 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.
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0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
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Participant Global Evaluation Over Time
Time Frame: 0-24, 0-48, 0-120 hours post-dose
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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.
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0-24, 0-48, 0-120 hours post-dose
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Time to Perceptible Relief
Time Frame: Within 6 hours of first dose on Day 1
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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.
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Within 6 hours of first dose on Day 1
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Time to Meaningful Relief
Time Frame: Within 6 hours of first dose on Day 1
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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.
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Within 6 hours of first dose on Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2007
Primary Completion (Actual)
October 14, 2008
Study Completion (Actual)
October 14, 2008
Study Registration Dates
First Submitted
July 23, 2007
First Submitted That Met QC Criteria
July 23, 2007
First Posted (Estimate)
July 25, 2007
Study Record Updates
Last Update Posted (Actual)
October 29, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac
- Diclofenac
Other Study ID Numbers
- DFC-005
- C1211009 (Other Identifier: Alias Study Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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