Postoperative Pain
Conditions
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.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Total 432 participants signed the inform consent form (ICF). Out of which 155 participants were not admitted into the study, 277 actually enrolled into the study and assigned to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac (DIC075V) Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. | 145 |
| Ketorolac Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. | 60 |
| Placebo Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. | 72 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Investigator Decision | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 6 | 4 | 21 |
| Overall Study | Other | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Diclofenac (DIC075V) | Ketorolac | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 55.9 Years STANDARD_DEVIATION 14.35 | 54.9 Years STANDARD_DEVIATION 15.77 | 54.5 Years STANDARD_DEVIATION 15.67 | 55.3 Years STANDARD_DEVIATION 14.97 |
| Sex: Female, Male Female | 92 Participants | 40 Participants | 46 Participants | 178 Participants |
| Sex: Female, Male Male | 53 Participants | 20 Participants | 26 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 109 / 145 | 46 / 60 | 60 / 72 |
| serious Total, serious adverse events | 7 / 145 | 4 / 60 | 3 / 72 |
Outcome results
Primary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac (DIC075V) | Sum of the Pain Intensity Differences (SPID) Over 120 Hours | 4835.6 mm*hours | Standard Deviation 2988.78 |
| Ketorolac | Sum of the Pain Intensity Differences (SPID) Over 120 Hours | 4359.1 mm*hours | Standard Deviation 3001.32 |
| Placebo | Sum of the Pain Intensity Differences (SPID) Over 120 Hours | 1840.5 mm*hours | Standard Deviation 2987.85 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Primary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac (DIC075V) | Sum of the Pain Intensity Differences (SPID) Over 24 Hours | 577.0 mm*hours | Standard Deviation 570.9 |
| Ketorolac | Sum of the Pain Intensity Differences (SPID) Over 24 Hours | 563.2 mm*hours | Standard Deviation 586.21 |
| Placebo | Sum of the Pain Intensity Differences (SPID) Over 24 Hours | 28.0 mm*hours | Standard Deviation 428.43 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Primary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac (DIC075V) | Sum of the Pain Intensity Differences (SPID) Over 48 Hours | 1527.5 mm*hours | Standard Deviation 1139.3 |
| Ketorolac | Sum of the Pain Intensity Differences (SPID) Over 48 Hours | 1371.8 mm*hours | Standard Deviation 1152.19 |
| Placebo | Sum of the Pain Intensity Differences (SPID) Over 48 Hours | 400.4 mm*hours | Standard Deviation 949.54 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Primary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac (DIC075V) | Sum of the Pain Intensity Differences (SPID) Over 72 Hours | 2592.1 mm*hours | Standard Deviation 1730.92 |
| Ketorolac | Sum of the Pain Intensity Differences (SPID) Over 72 Hours | 2312.1 mm*hours | Standard Deviation 1743.73 |
| Placebo | Sum of the Pain Intensity Differences (SPID) Over 72 Hours | 836.8 mm*hours | Standard Deviation 1564.24 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Primary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac (DIC075V) | Sum of the Pain Intensity Differences (SPID) Over 96 Hours | 3711.3 mm*hours | Standard Deviation 2347.25 |
| Ketorolac | Sum of the Pain Intensity Differences (SPID) Over 96 Hours | 3331.9 mm*hours | Standard Deviation 2356.36 |
| Placebo | Sum of the Pain Intensity Differences (SPID) Over 96 Hours | 1337.8 mm*hours | Standard Deviation 2261.5 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable at specific rows. Missing data was imputed using WOCF recorded over prior six hours (including baseline, if appropriate) in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac (DIC075V) | Cumulative Amount of Rescue Medication | 0-24 hours | 9.4 mg | Standard Deviation 7.2 |
| Diclofenac (DIC075V) | Cumulative Amount of Rescue Medication | 0-96 hours | 11.8 mg | Standard Deviation 9.73 |
| Diclofenac (DIC075V) | Cumulative Amount of Rescue Medication | 0-48 hours | 11.1 mg | Standard Deviation 9.06 |
| Diclofenac (DIC075V) | Cumulative Amount of Rescue Medication | 0-72 hours | 11.7 mg | Standard Deviation 9.56 |
| Diclofenac (DIC075V) | Cumulative Amount of Rescue Medication | 0-120 hours | 11.8 mg | Standard Deviation 9.73 |
| Ketorolac | Cumulative Amount of Rescue Medication | 0-24 hours | 11.5 mg | Standard Deviation 7.81 |
| Ketorolac | Cumulative Amount of Rescue Medication | 0-48 hours | 15.5 mg | Standard Deviation 13.99 |
| Ketorolac | Cumulative Amount of Rescue Medication | 0-120 hours | 18.1 mg | Standard Deviation 20.17 |
| Ketorolac | Cumulative Amount of Rescue Medication | 0-72 hours | 18.0 mg | Standard Deviation 20.11 |
| Ketorolac | Cumulative Amount of Rescue Medication | 0-96 hours | 18.1 mg | Standard Deviation 20.14 |
| Placebo | Cumulative Amount of Rescue Medication | 0-96 hours | 20.5 mg | Standard Deviation 16.17 |
| Placebo | Cumulative Amount of Rescue Medication | 0-24 hours | 16.0 mg | Standard Deviation 10.61 |
| Placebo | Cumulative Amount of Rescue Medication | 0-120 hours | 20.5 mg | Standard Deviation 16.17 |
| Placebo | Cumulative Amount of Rescue Medication | 0-72 hours | 20.5 mg | Standard Deviation 16.19 |
| Placebo | Cumulative Amount of Rescue Medication | 0-48 hours | 19.0 mg | Standard Deviation 13.89 |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Missing data was imputed using WOCF recorded over prior six hours (including baseline, if appropriate) in this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 1 | 23 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 2 | 22 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 4 | 11 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 5 | 6 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 6 | 7 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 7 | 5 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 8 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 9 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 10 | 5 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 13 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 15 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 17 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 19 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 20 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 21 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 8 | 2 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 9 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 4 | 11 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 10 | 2 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 12 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 15 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 20 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 0 | 38 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 1 | 23 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 2 | 22 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 6 | 8 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 7 | 4 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 9 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 13 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 15 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 20 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 2 | 22 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 4 | 11 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 10 | 5 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 11 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 12 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 17 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 0 | 38 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 3 | 15 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 11 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 12 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 14 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 0 | 39 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 1 | 26 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 2 | 26 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 3 | 19 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 4 | 8 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 5 | 9 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 6 | 7 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 7 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 11 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 12 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 13 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 14 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 15 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 0 | 38 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 1 | 23 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 2 | 24 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 3 | 14 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 5 | 7 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 6 | 8 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 7 | 6 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 8 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 9 | 4 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 11 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 13 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 14 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 17 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 3 | 15 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 4 | 11 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 5 | 6 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 8 | 4 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 10 | 5 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 11 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 12 | 2 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 14 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 17 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 19 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 21 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 0 | 38 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 1 | 23 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 3 | 15 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 5 | 6 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 6 | 7 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 7 | 5 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 8 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 9 | 3 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 13 | 1 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 14 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 15 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 19 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 20 | 0 Participants |
| Diclofenac (DIC075V) | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 21 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 6 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 10 | 3 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 10 | 4 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 11 | 3 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 15 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 12 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 0 | 16 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 12 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 4 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 10 | 3 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 11 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 14 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 13 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 15 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 15 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 19 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 21 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 0 | 17 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 17 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 2 | 9 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 13 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 19 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 4 | 4 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 5 | 3 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 20 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 6 | 3 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 7 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 8 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 9 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 21 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 12 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 13 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 21 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 14 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 0 | 16 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 15 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 14 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 0 | 16 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 1 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 1 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 2 | 10 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 3 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 4 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 3 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 6 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 20 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 7 | 4 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 5 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 8 | 3 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 9 | 4 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 10 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 1 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 2 | 10 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 3 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 17 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 11 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 5 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 6 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 7 | 4 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 13 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 8 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 9 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 7 | 4 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 12 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 14 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 14 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 15 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 17 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 20 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 17 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 1 | 6 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 3 | 8 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 0 | 16 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 11 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 5 | 3 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 2 | 10 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 12 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 8 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 20 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 1 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 4 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 3 | 5 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 19 | 0 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 5 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 7 | 4 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 9 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 11 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 6 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 13 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 9 | 1 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 2 | 10 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 8 | 2 Participants |
| Ketorolac | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 4 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 1 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 7 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 9 | 9 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 10 | 0 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 0 | 4 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 1 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 10 | 0 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 10 | 9 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 9 | 9 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 15 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 11 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 21 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 2 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 9 | 5 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 0 | 4 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 3 | 10 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 1 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 4 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 10 | 0 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 12 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 1 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 11 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 11 | 0 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 5 | 5 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 13 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 11 | 5 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 12 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 15 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 6 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 19 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 17 | 0 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 19 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 2 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 7 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 1 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 17 | 0 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 12 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 4 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 3 | 11 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 8 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 13 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 4 | 9 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 19 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 20 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 5 | 9 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 9 | 9 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 3 | 10 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 6 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 20 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 8 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 7 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 12 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 8 | 4 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 6 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 9 | 4 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 13 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 13 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 14 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 12 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 21 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 14 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 13 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 14 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 4 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 14 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 17 | 0 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 15 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 15 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 20 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 6 | 7 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 20 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 15 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 2 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-120 hours: 21 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 2 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 14 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 0 | 4 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 3 | 10 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 7 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 4 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 2 | 6 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 5 | 8 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 3 | 10 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 8 | 2 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 6 | 5 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 17 | 1 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-72 hours: 5 | 5 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 7 | 8 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 0 | 4 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0 - 24 Hours: 11 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 8 | 3 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-96 hours: 5 | 5 Participants |
| Placebo | Number of Participants According to Frequency of Use of Rescue Medication | 0-48 hours: 0 | 14 Participants |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 3 hours | 13.5 mm | Standard Deviation 29.3 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 24 hours | 31.8 mm | Standard Deviation 32.47 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 21 hours | 36.3 mm | Standard Deviation 31.03 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 5 hours | 10.8 mm | Standard Deviation 30.11 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 30 minutes | 17.7 mm | Standard Deviation 24.36 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 18 hours | 30.2 mm | Standard Deviation 32.27 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 6 hours | 12.6 mm | Standard Deviation 31.05 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 5 minutes | 5.2 mm | Standard Deviation 14.27 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 15 hours | 28.5 mm | Standard Deviation 31.34 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 9 hours | 23.6 mm | Standard Deviation 32.07 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 120 hours | 46.9 mm | Standard Deviation 28.42 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 12 hours | 23.4 mm | Standard Deviation 31.83 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 96 hours | 46.8 mm | Standard Deviation 28.42 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 45 minutes | 18.5 mm | Standard Deviation 27.12 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 15 minutes | 13.4 mm | Standard Deviation 22.06 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 72 hours | 47.0 mm | Standard Deviation 27.65 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 1 hour | 18.7 mm | Standard Deviation 28.54 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 2 hours | 17.3 mm | Standard Deviation 30.22 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 10 minutes | 9.1 mm | Standard Deviation 19.36 |
| Diclofenac (DIC075V) | Pain Intensity Differences (PID) Over Time | At 48 hours | 42.9 mm | Standard Deviation 29.17 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 120 hours | 42.9 mm | Standard Deviation 28.91 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 5 minutes | 3.2 mm | Standard Deviation 15.85 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 10 minutes | 5.5 mm | Standard Deviation 19.61 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 15 minutes | 9.8 mm | Standard Deviation 23.21 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 1 hour | 19.7 mm | Standard Deviation 31.6 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 30 minutes | 16.7 mm | Standard Deviation 23.22 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 45 minutes | 18.4 mm | Standard Deviation 27.56 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 2 hours | 16.9 mm | Standard Deviation 32.81 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 3 hours | 14.7 mm | Standard Deviation 32.94 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 5 hours | 15.1 mm | Standard Deviation 32.01 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 6 hours | 12.5 mm | Standard Deviation 29.69 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 9 hours | 21.3 mm | Standard Deviation 33.34 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 12 hours | 23.7 mm | Standard Deviation 32.44 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 15 hours | 23.2 mm | Standard Deviation 35.19 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 18 hours | 30.1 mm | Standard Deviation 32.8 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 21 hours | 39.1 mm | Standard Deviation 32.41 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 24 hours | 27.5 mm | Standard Deviation 32.96 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 48 hours | 35.5 mm | Standard Deviation 30.38 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 96 hours | 43.0 mm | Standard Deviation 28.92 |
| Ketorolac | Pain Intensity Differences (PID) Over Time | At 72 hours | 41.0 mm | Standard Deviation 30.4 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 18 hours | 8.7 mm | Standard Deviation 24.16 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 3 hours | -8.9 mm | Standard Deviation 19.21 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 21 hours | 8.8 mm | Standard Deviation 26.66 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 15 minutes | 2.2 mm | Standard Deviation 25.41 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 24 hours | 12.9 mm | Standard Deviation 26.38 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 2 hours | -7.8 mm | Standard Deviation 23.86 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 5 minutes | 1.2 mm | Standard Deviation 15.21 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 48 hours | 19.4 mm | Standard Deviation 29.69 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 45 minutes | -1.2 mm | Standard Deviation 30.15 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 72 hours | 20.3 mm | Standard Deviation 31.44 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 30 minutes | 2.6 mm | Standard Deviation 30.16 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 9 hours | -1.8 mm | Standard Deviation 22.91 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 10 minutes | 2.4 mm | Standard Deviation 21.46 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 12 hours | 1.4 mm | Standard Deviation 24.75 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 6 hours | -6.1 mm | Standard Deviation 21.31 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 120 hours | 20.9 mm | Standard Deviation 31.48 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 15 hours | 1.1 mm | Standard Deviation 25.35 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 5 hours | -7.3 mm | Standard Deviation 20.76 |
| Placebo | Pain Intensity Differences (PID) Over Time | At 1 hour | -4.2 mm | Standard Deviation 28.03 |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable at specific rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac (DIC075V) | Participant Global Evaluation Over Time | 0-48 Hours | 2.9 Units on a scale | Standard Deviation 1.15 |
| Diclofenac (DIC075V) | Participant Global Evaluation Over Time | 0-24 Hours | 2.6 Units on a scale | Standard Deviation 1.27 |
| Diclofenac (DIC075V) | Participant Global Evaluation Over Time | 0-120 Hours | 2.9 Units on a scale | Standard Deviation 1.26 |
| Ketorolac | Participant Global Evaluation Over Time | 0-48 Hours | 2.6 Units on a scale | Standard Deviation 0.86 |
| Ketorolac | Participant Global Evaluation Over Time | 0-24 Hours | 2.4 Units on a scale | Standard Deviation 1.16 |
| Ketorolac | Participant Global Evaluation Over Time | 0-120 Hours | 2.6 Units on a scale | Standard Deviation 1.16 |
| Placebo | Participant Global Evaluation Over Time | 0-24 Hours | 1.1 Units on a scale | Standard Deviation 1.25 |
| Placebo | Participant Global Evaluation Over Time | 0-120 Hours | 1.3 Units on a scale | Standard Deviation 1.38 |
| Placebo | Participant Global Evaluation Over Time | 0-48 Hours | 1.9 Units on a scale | Standard Deviation 1.42 |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 5 minutes | 13.8 Percentage of participants |
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 30 minutes | 43.4 Percentage of participants |
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 1 hour | 44.8 Percentage of participants |
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 24 hours | 62.1 Percentage of participants |
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 48 hours | 75.2 Percentage of participants |
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 72 hours | 80.0 Percentage of participants |
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 90 hours | 80.0 Percentage of participants |
| Diclofenac (DIC075V) | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 120 hours | 80.7 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 1 hour | 41.7 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 90 hours | 75.0 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 24 hours | 56.7 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 48 hours | 63.3 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 72 hours | 71.7 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 5 minutes | 10.0 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 30 minutes | 35.0 Percentage of participants |
| Ketorolac | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 120 hours | 75.0 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 1 hour | 15.3 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 30 minutes | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 5 minutes | 8.3 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 24 hours | 31.09 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 90 hours | 43.1 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 72 hours | 41.7 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 48 hours | 41.7 Percentage of participants |
| Placebo | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | At 120 hours | 43.1 Percentage of participants |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Missing data was imputed using worst observation carried forward (WOCF) recorded over prior six hours (including baseline, if appropriate) in this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diclofenac (DIC075V) | Time From Administration of Study Drug to Administration of Rescue Medication | 220.0 Minutes |
| Ketorolac | Time From Administration of Study Drug to Administration of Rescue Medication | 137.0 Minutes |
| Placebo | Time From Administration of Study Drug to Administration of Rescue Medication | 51.0 Minutes |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diclofenac (DIC075V) | Time to Meaningful Relief | 41.6 Minutes |
| Ketorolac | Time to Meaningful Relief | 42.5 Minutes |
| Placebo | Time to Meaningful Relief | NA Minutes |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diclofenac (DIC075V) | Time to Perceptible Relief | 10.0 Minutes |
| Ketorolac | Time to Perceptible Relief | 14.4 Minutes |
| Placebo | Time to Perceptible Relief | 15.0 Minutes |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac (DIC075V) | Total Pain Relief (TOTPAR) | 0-24 hours | 1177.6 mm*hours | Standard Deviation 611.13 |
| Diclofenac (DIC075V) | Total Pain Relief (TOTPAR) | 0-96 hours | 6252.2 mm*hours | Standard Deviation 2577.46 |
| Diclofenac (DIC075V) | Total Pain Relief (TOTPAR) | 0-72 hours | 4471.0 mm*hours | Standard Deviation 1898.89 |
| Diclofenac (DIC075V) | Total Pain Relief (TOTPAR) | 0-120 hours | 8042.5 mm*hours | Standard Deviation 3282.39 |
| Diclofenac (DIC075V) | Total Pain Relief (TOTPAR) | 0-48 hours | 2768.3 mm*hours | Standard Deviation 1239.29 |
| Ketorolac | Total Pain Relief (TOTPAR) | 0-120 hours | 7178.0 mm*hours | Standard Deviation 3627.97 |
| Ketorolac | Total Pain Relief (TOTPAR) | 0-24 hours | 1065.4 mm*hours | Standard Deviation 616.28 |
| Ketorolac | Total Pain Relief (TOTPAR) | 0-48 hours | 2453.8 mm*hours | Standard Deviation 1323.35 |
| Ketorolac | Total Pain Relief (TOTPAR) | 0-72 hours | 3983.6 mm*hours | Standard Deviation 2056.63 |
| Ketorolac | Total Pain Relief (TOTPAR) | 0-96 hours | 5575.7 mm*hours | Standard Deviation 2828.49 |
| Placebo | Total Pain Relief (TOTPAR) | 0-48 hours | 1327.9 mm*hours | Standard Deviation 1258.96 |
| Placebo | Total Pain Relief (TOTPAR) | 0-120 hours | 4105.4 mm*hours | Standard Deviation 3922.22 |
| Placebo | Total Pain Relief (TOTPAR) | 0-96 hours | 3159.4 mm*hours | Standard Deviation 3002.62 |
| Placebo | Total Pain Relief (TOTPAR) | 0-24 hours | 484.7 mm*hours | Standard Deviation 502.91 |
| Placebo | Total Pain Relief (TOTPAR) | 0-72 hours | 2214.6 mm*hours | Standard Deviation 2103.25 |
Secondary
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
Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 15 minutes | 33.5 mm | Standard Deviation 28.04 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 15 hours | 55.7 mm | Standard Deviation 33.55 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 3 hours | 33.5 mm | Standard Deviation 37.06 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 5 minutes | 21.9 mm | Standard Deviation 25.27 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 12 hours | 51.6 mm | Standard Deviation 33.42 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 5 hours | 28.8 mm | Standard Deviation 35.45 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 120 hours | 74.6 mm | Standard Deviation 31.15 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 9 hours | 49.5 mm | Standard Deviation 35.12 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 6 hours | 36.7 mm | Standard Deviation 34.78 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 48 hours | 69.4 mm | Standard Deviation 31.52 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 30 minutes | 39.7 mm | Standard Deviation 30.47 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 10 minutes | 27.1 mm | Standard Deviation 26.89 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 24 hours | 59.7 mm | Standard Deviation 33.73 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 45 minutes | 41.6 mm | Standard Deviation 33.14 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 96 hours | 74.6 mm | Standard Deviation 31.11 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 21 hours | 63.6 mm | Standard Deviation 32.75 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 1 hour | 40.0 mm | Standard Deviation 34.64 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 72 hours | 74.4 mm | Standard Deviation 31.01 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 18 hours | 56.6 mm | Standard Deviation 33 |
| Diclofenac (DIC075V) | Visual Analog Pain Relief Values Over the Time | At 2 hours | 35.3 mm | Standard Deviation 36.99 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 3 hours | 29.5 mm | Standard Deviation 37.09 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 5 minutes | 17.9 mm | Standard Deviation 25.26 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 10 minutes | 23.6 mm | Standard Deviation 28.15 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 15 minutes | 27.2 mm | Standard Deviation 30.74 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 30 minutes | 33.9 mm | Standard Deviation 33.04 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 45 minutes | 33.3 mm | Standard Deviation 33.64 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 1 hour | 37.8 mm | Standard Deviation 37.21 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 2 hours | 33.2 mm | Standard Deviation 37.98 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 5 hours | 31.0 mm | Standard Deviation 36.74 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 6 hours | 33.9 mm | Standard Deviation 32.54 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 9 hours | 39.4 mm | Standard Deviation 34.59 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 12 hours | 46.3 mm | Standard Deviation 34.44 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 15 hours | 45.9 mm | Standard Deviation 34.08 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 18 hours | 53.6 mm | Standard Deviation 33.98 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 21 hours | 63.2 mm | Standard Deviation 33.05 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 24 hours | 53.4 mm | Standard Deviation 34.87 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 48 hours | 60.8 mm | Standard Deviation 33.83 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 72 hours | 64.8 mm | Standard Deviation 35.41 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 96 hours | 67.0 mm | Standard Deviation 34.96 |
| Ketorolac | Visual Analog Pain Relief Values Over the Time | At 120 hours | 66.9 mm | Standard Deviation 34.89 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 96 hours | 39.4 mm | Standard Deviation 39.19 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 1 hour | 17.1 mm | Standard Deviation 30.67 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 10 minutes | 19.0 mm | Standard Deviation 24.27 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 18 hours | 28.3 mm | Standard Deviation 30.07 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 45 minutes | 19.9 mm | Standard Deviation 31.67 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 5 minutes | 15.3 mm | Standard Deviation 21.68 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 21 hours | 27.4 mm | Standard Deviation 32.73 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 30 minutes | 23.1 mm | Standard Deviation 31.95 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 72 hours | 38.8 mm | Standard Deviation 38.77 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 24 hours | 32.5 mm | Standard Deviation 35.25 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 6 hours | 12.6 mm | Standard Deviation 24.1 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 5 hours | 8.0 mm | Standard Deviation 21.96 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 15 minutes | 21.6 mm | Standard Deviation 28.54 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 9 hours | 17.5 mm | Standard Deviation 26.2 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 3 hours | 8.0 mm | Standard Deviation 22.07 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 120 hours | 39.4 mm | Standard Deviation 39.19 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 12 hours | 21.6 mm | Standard Deviation 27.46 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 2 hours | 10.1 mm | Standard Deviation 23.97 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 48 hours | 38.2 mm | Standard Deviation 37.73 |
| Placebo | Visual Analog Pain Relief Values Over the Time | At 15 hours | 21.4 mm | Standard Deviation 26.15 |