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CompletedNCT00507026Updated Oct 29, 2021Results posted

Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery

A Phase 3 interventional study of IV Diclofenac and IV ketorolac in Postoperative Pain, sponsored by Pfizer. Completed at 8 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-29.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
277
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

Read the 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.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 277 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
277 participants (actual)

Study arms

  • Experimental
    A

    DIC075V (IV diclofenac)

    Drug: IV Diclofenac

  • Active comparator
    B

    IV Ketorolac

    Drug: IV ketorolac

  • Placebo comparator
    C

    Placebo

    Drug: Placebo

Interventions

  • DrugIV Diclofenac

    IV Diclofenac q6h

  • DrugIV ketorolac

    IV ketorolac q6h

  • DrugPlacebo

    Placebo q6h

06

What researchers measure

Primary outcomes

  1. Sum of the Pain Intensity Differences (SPID) Over 24 Hours

    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.

    Time frame: Over 24 hours post first dose

  2. Sum of the Pain Intensity Differences (SPID) Over 48 Hours

    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.

    Time frame: Over 48 hours post first dose

  3. Sum of the Pain Intensity Differences (SPID) Over 72 Hours

    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.

    Time frame: Over 72 hours post first dose

  4. Sum of the Pain Intensity Differences (SPID) Over 96 Hours

    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.

    Time frame: Over 96 hours post first dose

  5. Sum of the Pain Intensity Differences (SPID) Over 120 Hours

    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.

    Time frame: Over 120 hours post first dose

Secondary outcomes

  1. Pain Intensity Differences (PID) Over Time

    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.

    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

  2. Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity

    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.

    Time frame: Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose

  3. Total Pain Relief (TOTPAR)

    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.

    Time frame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose

  4. Visual Analog Pain Relief Values Over the Time

    Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief.

    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

  5. Time From Administration of Study Drug to Administration of Rescue Medication

    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.

    Time frame: Maximum up to 5 days

  6. Cumulative Amount of Rescue Medication

    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 frame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours

  7. Number of Participants According to Frequency of Use of Rescue Medication

    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.

    Time frame: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose

  8. Participant Global Evaluation Over Time

    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.

    Time frame: 0-24, 0-48, 0-120 hours post-dose

  9. Time to Perceptible Relief

    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 frame: Within 6 hours of first dose on Day 1

  10. Time to Meaningful Relief

    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.

    Time frame: Within 6 hours of first dose on Day 1

07

Results

Posted Oct 29, 2021

Participant flow

Participants who required elective general orthopedic surgery were eligible for participation in this study. Within 6 hours after completion of surgery, participants who experienced moderate to severe pain, as measured by a 0-100 millimeter (mm) visual analog scale (VAS) with pain intensity (PI) score of greater than or equal to (\>=) 50 mm and who met all eligibility criteria were enrolled into the study.

Participant flow — Overall Study
MilestoneDiclofenac (DIC075V)KetorolacPlacebo
Started1456072
Completed1325651
Not completed13421
Withdrew: Lack of efficacy6421
Withdrew: Withdrawal by subject200
Withdrew: Investigator decision100
Withdrew: Adverse event200
Withdrew: Protocol violation100
Withdrew: Other100

Outcome measures

PrimarySum of the Pain Intensity Differences (SPID) Over 24 Hours

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.

Time frame:
Over 24 hours post first dose
Reported as:
Mean · mm*hours
Sum of the Pain Intensity Differences (SPID) Over 24 Hours
mm*hoursDiclofenac (DIC075V)KetorolacPlacebo
Sum of the Pain Intensity Differences (SPID) Over 24 Hours577.0 ± 570.90563.2 ± 586.2128.0 ± 428.43
Statistical analysis
  • Diclofenac (DIC075V) vs Placebo · ANCOVA · p = <0.0001
  • Ketorolac vs Placebo · ANCOVA · p = <0.0001
PrimarySum of the Pain Intensity Differences (SPID) Over 48 Hours

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.

Time frame:
Over 48 hours post first dose
Reported as:
Mean · mm*hours
Sum of the Pain Intensity Differences (SPID) Over 48 Hours
mm*hoursDiclofenac (DIC075V)KetorolacPlacebo
Sum of the Pain Intensity Differences (SPID) Over 48 Hours1527.5 ± 1139.301371.8 ± 1152.19400.4 ± 949.54
Statistical analysis
  • Diclofenac (DIC075V) vs Placebo · ANCOVA · p = <0.0001
  • Ketorolac vs Placebo · ANCOVA · p = <0.0001
PrimarySum of the Pain Intensity Differences (SPID) Over 72 Hours

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.

Time frame:
Over 72 hours post first dose
Reported as:
Mean · mm*hours
Sum of the Pain Intensity Differences (SPID) Over 72 Hours
mm*hoursDiclofenac (DIC075V)KetorolacPlacebo
Sum of the Pain Intensity Differences (SPID) Over 72 Hours2592.1 ± 1730.922312.1 ± 1743.73836.8 ± 1564.24
Statistical analysis
  • Diclofenac (DIC075V) vs Placebo · ANCOVA · p = <0.0001
  • Ketorolac vs Placebo · ANCOVA · p = <0.0001
PrimarySum of the Pain Intensity Differences (SPID) Over 96 Hours

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.

Time frame:
Over 96 hours post first dose
Reported as:
Mean · mm*hours
Sum of the Pain Intensity Differences (SPID) Over 96 Hours
mm*hoursDiclofenac (DIC075V)KetorolacPlacebo
Sum of the Pain Intensity Differences (SPID) Over 96 Hours3711.3 ± 2347.253331.9 ± 2356.361337.8 ± 2261.50
Statistical analysis
  • Diclofenac (DIC075V) vs Placebo · ANCOVA · p = <0.0001
  • Ketorolac vs Placebo · ANCOVA · p = <0.0001
PrimarySum of the Pain Intensity Differences (SPID) Over 120 Hours

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.

Time frame:
Over 120 hours post first dose
Reported as:
Mean · mm*hours
Sum of the Pain Intensity Differences (SPID) Over 120 Hours
mm*hoursDiclofenac (DIC075V)KetorolacPlacebo
Sum of the Pain Intensity Differences (SPID) Over 120 Hours4835.6 ± 2988.784359.1 ± 3001.321840.5 ± 2987.85
Statistical analysis
  • Diclofenac (DIC075V) vs Placebo · ANCOVA · p = <0.0001
  • Ketorolac vs Placebo · ANCOVA · p = <0.0001
SecondaryPain Intensity Differences (PID) Over Time

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.

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
Reported as:
Mean · mm
Pain Intensity Differences (PID) Over Time
mmDiclofenac (DIC075V)KetorolacPlacebo
At 5 minutes5.2 ± 14.273.2 ± 15.851.2 ± 15.21
At 10 minutes9.1 ± 19.365.5 ± 19.612.4 ± 21.46
At 15 minutes13.4 ± 22.069.8 ± 23.212.2 ± 25.41
At 30 minutes17.7 ± 24.3616.7 ± 23.222.6 ± 30.16
At 45 minutes18.5 ± 27.1218.4 ± 27.56-1.2 ± 30.15
At 1 hour18.7 ± 28.5419.7 ± 31.60-4.2 ± 28.03
At 2 hours17.3 ± 30.2216.9 ± 32.81-7.8 ± 23.86
At 3 hours13.5 ± 29.3014.7 ± 32.94-8.9 ± 19.21
At 5 hours10.8 ± 30.1115.1 ± 32.01-7.3 ± 20.76
At 6 hours12.6 ± 31.0512.5 ± 29.69-6.1 ± 21.31
At 9 hours23.6 ± 32.0721.3 ± 33.34-1.8 ± 22.91
At 12 hours23.4 ± 31.8323.7 ± 32.441.4 ± 24.75
At 15 hours28.5 ± 31.3423.2 ± 35.191.1 ± 25.35
At 18 hours30.2 ± 32.2730.1 ± 32.808.7 ± 24.16
At 21 hours36.3 ± 31.0339.1 ± 32.418.8 ± 26.66
At 24 hours31.8 ± 32.4727.5 ± 32.9612.9 ± 26.38
At 48 hours42.9 ± 29.1735.5 ± 30.3819.4 ± 29.69
At 72 hours47.0 ± 27.6541.0 ± 30.4020.3 ± 31.44
At 96 hours46.8 ± 28.4243.0 ± 28.92—
At 120 hours46.9 ± 28.4242.9 ± 28.9120.9 ± 31.48
SecondaryPercentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity

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.

Time frame:
Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose
Reported as:
Number · Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity
Percentage of participantsDiclofenac (DIC075V)KetorolacPlacebo
At 5 minutes13.810.08.3
At 30 minutes43.435.025.0
At 1 hour44.841.715.3
At 24 hours62.156.731.09
At 48 hours75.263.341.7
At 72 hours80.071.741.7
At 90 hours80.075.043.1
At 120 hours80.775.043.1
SecondaryTotal Pain Relief (TOTPAR)

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.

Time frame:
0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
Reported as:
Mean · mm*hours
Total Pain Relief (TOTPAR)
mm*hoursDiclofenac (DIC075V)KetorolacPlacebo
0-24 hours1177.6 ± 611.131065.4 ± 616.28484.7 ± 502.91
0-48 hours2768.3 ± 1239.292453.8 ± 1323.351327.9 ± 1258.96
0-72 hours4471.0 ± 1898.893983.6 ± 2056.632214.6 ± 2103.25
0-96 hours6252.2 ± 2577.465575.7 ± 2828.493159.4 ± 3002.62
0-120 hours8042.5 ± 3282.397178.0 ± 3627.974105.4 ± 3922.22
SecondaryVisual Analog Pain Relief Values Over the Time

Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief.

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
Reported as:
Mean · mm
Visual Analog Pain Relief Values Over the Time
mmDiclofenac (DIC075V)KetorolacPlacebo
At 5 minutes21.9 ± 25.2717.9 ± 25.2615.3 ± 21.68
At 10 minutes27.1 ± 26.8923.6 ± 28.1519.0 ± 24.27
At 15 minutes33.5 ± 28.0427.2 ± 30.7421.6 ± 28.54
At 30 minutes39.7 ± 30.4733.9 ± 33.0423.1 ± 31.95
At 45 minutes41.6 ± 33.1433.3 ± 33.6419.9 ± 31.67
At 1 hour40.0 ± 34.6437.8 ± 37.2117.1 ± 30.67
At 2 hours35.3 ± 36.9933.2 ± 37.9810.1 ± 23.97
At 3 hours33.5 ± 37.0629.5 ± 37.098.0 ± 22.07
At 5 hours28.8 ± 35.4531.0 ± 36.748.0 ± 21.96
At 6 hours36.7 ± 34.7833.9 ± 32.5412.6 ± 24.10
At 9 hours49.5 ± 35.1239.4 ± 34.5917.5 ± 26.20
At 12 hours51.6 ± 33.4246.3 ± 34.4421.6 ± 27.46
At 15 hours55.7 ± 33.5545.9 ± 34.0821.4 ± 26.15
At 18 hours56.6 ± 33.0053.6 ± 33.9828.3 ± 30.07
At 21 hours63.6 ± 32.7563.2 ± 33.0527.4 ± 32.73
At 24 hours59.7 ± 33.7353.4 ± 34.8732.5 ± 35.25
At 48 hours69.4 ± 31.5260.8 ± 33.8338.2 ± 37.73
At 72 hours74.4 ± 31.0164.8 ± 35.4138.8 ± 38.77
At 96 hours74.6 ± 31.1167.0 ± 34.9639.4 ± 39.19
At 120 hours74.6 ± 31.1566.9 ± 34.8939.4 ± 39.19
SecondaryTime From Administration of Study Drug to Administration of Rescue Medication

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.

Time frame:
Maximum up to 5 days
Reported as:
Median · Minutes
Time From Administration of Study Drug to Administration of Rescue Medication
MinutesDiclofenac (DIC075V)KetorolacPlacebo
Time From Administration of Study Drug to Administration of Rescue Medication220.0 (125.0 to 272.0)137.0 (63.0 to 302.0)51.0 (35.0 to 71.0)
SecondaryCumulative Amount of Rescue Medication

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 frame:
0-24, 0-48, 0-72, 0-96 and 0-120 hours
Reported as:
Mean · mg
Cumulative Amount of Rescue Medication
mgDiclofenac (DIC075V)KetorolacPlacebo
0-24 hours9.4 ± 7.2011.5 ± 7.8116.0 ± 10.61
0-48 hours11.1 ± 9.0615.5 ± 13.9919.0 ± 13.89
0-72 hours11.7 ± 9.5618.0 ± 20.1120.5 ± 16.19
0-96 hours11.8 ± 9.7318.1 ± 20.1420.5 ± 16.17
0-120 hours11.8 ± 9.7318.1 ± 20.1720.5 ± 16.17
SecondaryNumber of Participants According to Frequency of Use of Rescue Medication

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.

Time frame:
0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
Reported as:
Count of participants · Participants
Number of Participants According to Frequency of Use of Rescue Medication
ParticipantsDiclofenac (DIC075V)KetorolacPlacebo
0 - 24 Hours: 039174
0 - 24 Hours: 12667
0 - 24 Hours: 22696
0 - 24 Hours: 319811
0 - 24 Hours: 4849
0 - 24 Hours: 5939
0 - 24 Hours: 6733
0 - 24 Hours: 7357
0 - 24 Hours: 8224
0 - 24 Hours: 9314
0 - 24 Hours: 11113
0 - 24 Hours: 12112
0 - 24 Hours: 13101
0 - 24 Hours: 14001
0 - 24 Hours: 15001
0-48 hours: 0381614
0-48 hours: 12357
0-48 hours: 224106
0-48 hours: 314510
0-48 hours: 41123
0-48 hours: 5738
0-48 hours: 6825
0-48 hours: 7648
0-48 hours: 8333
0-48 hours: 9445
0-48 hours: 10220
0-48 hours: 11315
0-48 hours: 12123
0-48 hours: 13111
0-48 hours: 14001
0-48 hours: 15001
0-48 hours: 17001
0-48 hours: 20001
0-72 hours: 038164
0-72 hours: 12357
0-72 hours: 222106
0-72 hours: 315510
0-72 hours: 41123
0-72 hours: 5625
0-72 hours: 6827
0-72 hours: 7446
0-72 hours: 8422
0-72 hours: 9319
0-72 hours: 10549
0-72 hours: 11320
0-72 hours: 12212
0-72 hours: 13113
0-72 hours: 14001
0-72 hours: 15022
0-72 hours: 17010
0-72 hours: 19001
0-72 hours: 20001
0-72 hours: 21001
0-96 hours: 038164
0-96 hours: 12357
0-96 hours: 222106
0-96 hours: 315510
0-96 hours: 41123
0-96 hours: 5625
0-96 hours: 6726
0-96 hours: 7547
0-96 hours: 8322
0-96 hours: 9319
0-96 hours: 10530
0-96 hours: 11332
0-96 hours: 12313
0-96 hours: 13111
0-96 hours: 14002
0-96 hours: 15022
0-96 hours: 17010
0-96 hours: 19001
0-96 hours: 20001
0-96 hours: 21001
0-120 hours: 038164
0-120 hours: 12357
0-120 hours: 222106
0-120 hours: 315510
0-120 hours: 41123
0-120 hours: 5625
0-120 hours: 6726
0-120 hours: 7547
0-120 hours: 8322
0-120 hours: 9319
0-120 hours: 10530
0-120 hours: 11322
0-120 hours: 12323
0-120 hours: 13111
0-120 hours: 14002
0-120 hours: 15022
0-120 hours: 17010
0-120 hours: 19001
0-120 hours: 20001
0-120 hours: 21001
SecondaryParticipant Global Evaluation Over Time

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.

Time frame:
0-24, 0-48, 0-120 hours post-dose
Reported as:
Mean · Units on a scale
Participant Global Evaluation Over Time
Units on a scaleDiclofenac (DIC075V)KetorolacPlacebo
0-24 Hours2.6 ± 1.272.4 ± 1.161.1 ± 1.25
0-48 Hours2.9 ± 1.152.6 ± 0.861.9 ± 1.42
0-120 Hours2.9 ± 1.262.6 ± 1.161.3 ± 1.38
SecondaryTime to Perceptible Relief

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 frame:
Within 6 hours of first dose on Day 1
Reported as:
Median · Minutes
Time to Perceptible Relief
MinutesDiclofenac (DIC075V)KetorolacPlacebo
Time to Perceptible Relief10.0 (0 to 194)14.4 (0 to 85)15.0 (1 to 187)
SecondaryTime to Meaningful Relief

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.

Time frame:
Within 6 hours of first dose on Day 1
Reported as:
Median · Minutes
Time to Meaningful Relief
MinutesDiclofenac (DIC075V)KetorolacPlacebo
Time to Meaningful Relief41.6 (31.0 to 58.6)42.5 (30.0 to 51.7)NA (NA to NA)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Diclofenac (DIC075V)—7/145 (4.8%)109/145 (75.2%)
Ketorolac—4/60 (6.7%)46/60 (76.7%)
Placebo—3/72 (4.2%)60/72 (83.3%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventDiclofenac (DIC075V)KetorolacPlacebo
Deep vein thrombosisVascular disorders3/1450/600/72
Cardiac failure congestiveCardiac disorders0/1451/600/72
Staphylococcal infectionInfections and infestations0/1451/600/72
Urinary tract infectionInfections and infestations0/1451/600/72
Femur fractureInjury, poisoning and procedural complications0/1451/600/72
Blindness unilateralEye disorders0/1450/601/72
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/1450/601/72
HypotensionVascular disorders0/1450/601/72
Abdominal painGastrointestinal disorders1/1450/600/72
Clostridium difficile colitisInfections and infestations1/1450/600/72
Most frequent other events
Showing 10 of 163
Most frequent other events
EventDiclofenac (DIC075V)KetorolacPlacebo
NauseaGastrointestinal disorders36/14518/6026/72
VomitingGastrointestinal disorders11/1456/6014/72
ConstipationGastrointestinal disorders19/1456/6011/72
Blood creatine phosphokinase increasedInvestigations21/1458/609/72
PyrexiaGeneral disorders4/1453/609/72
AnaemiaBlood and lymphatic system disorders9/1457/608/72
DizzinessNervous system disorders16/1455/605/72
RashSkin and subcutaneous tissue disorders4/1456/600/72
Infusion site painGeneral disorders11/1455/605/72
HeadacheNervous system disorders12/1455/605/72

Baseline characteristics

Intent-To-Treat (ITT) population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Age, Continuous
Age, Continuous(Years)Diclofenac (DIC075V)KetorolacPlaceboTotal
Mean55.9 ± 14.3554.9 ± 15.7754.5 ± 15.6755.3 ± 14.97
Sex: Female, Male
Sex: Female, Male(Participants)Diclofenac (DIC075V)KetorolacPlaceboTotal
Female924046178
Male53202699
08

Study locations

8 sites
  • Helen Keller Hospital
    Sheffield, Alabama 35660, United States
  • Arizona Research Center
    Phoenix, Arizona 85023, United States
  • Accurate Clinical Trials
    San Clemente, California 92672, United States
  • East Coast Clincial Research
    Fort Pierce, Florida 34950, United States
  • Outcomes Research Institute
    Louisville, Kentucky 40202, United States
  • American Institute of Healthcare and Fitness
    Raleigh, North Carolina 27615, United States
  • University Orthopedics Center
    State College, Pennsylvania 16081, United States
  • SCIREX
    Austin, Texas 78705, United States
09

References and documents

Publications

  • Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3. PubMed 29492863 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00507026
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jul 25, 2007
Start date
Jul 25, 2007
Primary completion
Oct 14, 2008
Completion
Oct 14, 2008
Results posted
Oct 29, 2021
Last update
Oct 29, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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