Trial · NCT00507026
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
NCT00507026, Phase 3, Completed, Pfizer; results first posted 2021-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery. Trials, record NCT00507026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00507026
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
- NCT number
- NCT00507026
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 277 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Postoperative Pain
- Interventions
- IV Diclofenac, IV ketorolac, Placebo
- First posted
- 2007-07-25
- Last updated
- 2021-10-29
- Results first posted
- 2021-10-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of the Pain Intensity Differences (SPID) Over 24 Hours | Over 24 hours post first dose | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | mm*hours | MEAN |
| PRIMARY | Sum of the Pain Intensity Differences (SPID) Over 48 Hours | Over 48 hours post first dose | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | mm*hours | MEAN |
| PRIMARY | Sum of the Pain Intensity Differences (SPID) Over 72 Hours | Over 72 hours post first dose | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | mm*hours | MEAN |
| PRIMARY | Sum of the Pain Intensity Differences (SPID) Over 96 Hours | Over 96 hours post first dose | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | mm*hours | MEAN |
| PRIMARY | Sum of the Pain Intensity Differences (SPID) Over 120 Hours | Over 120 hours post first dose | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | mm*hours | MEAN |
| SECONDARY | 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 | 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. | mm | MEAN |
| SECONDARY | 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 | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Total Pain Relief (TOTPAR) | 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | mm*hours | MEAN |
| SECONDARY | 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 | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | mm | MEAN |
| SECONDARY | Time From Administration of Study Drug to Administration of Rescue Medication | Maximum up to 5 days | 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. | Minutes | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group485
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sum of the Pain Intensity Differences (SPID) Over 24 Hours | Diclofenac (DIC075V) | 577.0 | Standard Deviation 570.90 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 24 Hours | Ketorolac | 563.2 | Standard Deviation 586.21 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 24 Hours | Placebo | 28.0 | Standard Deviation 428.43 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 48 Hours | Diclofenac (DIC075V) | 1527.5 | Standard Deviation 1139.30 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 48 Hours | Ketorolac | 1371.8 | Standard Deviation 1152.19 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 48 Hours | Placebo | 400.4 | Standard Deviation 949.54 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 72 Hours | Diclofenac (DIC075V) | 2592.1 | Standard Deviation 1730.92 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 72 Hours | Ketorolac | 2312.1 | Standard Deviation 1743.73 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 72 Hours | Placebo | 836.8 | Standard Deviation 1564.24 | mm*hours | |
| Sum of the Pain Intensity Differences (SPID) Over 96 Hours | Diclofenac (DIC075V) | 3711.3 | Standard Deviation 2347.25 | mm*hours |
1 to 10 of 485Source ClinicalTrials.gov
See all 485 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diclofenac (DIC075V) | 145 | |
| Overall Study | STARTED | Ketorolac | 60 | |
| Overall Study | STARTED | Placebo | 72 | |
| Overall Study | COMPLETED | Diclofenac (DIC075V) | 132 | |
| Overall Study | COMPLETED | Ketorolac | 56 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | NOT COMPLETED | Diclofenac (DIC075V) | 13 | |
| Overall Study | NOT COMPLETED | Ketorolac | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events528
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Diclofenac (DIC075V) | 9 | 145 | |
| other | Anaemia | Blood and lymphatic system disorders | Ketorolac | 7 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 8 | 72 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Diclofenac (DIC075V) | 1 | 145 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Ketorolac | 0 | 60 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Placebo | 0 | 72 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Diclofenac (DIC075V) | 1 | 145 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ketorolac | 0 | 60 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 72 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Diclofenac (DIC075V) | 1 | 145 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diclofenac (DIC075V) | ||
| Total, all-cause mortality | Ketorolac | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Diclofenac (DIC075V) | 109 | 145 |
| Total, other adverse events | Ketorolac | 46 | 60 |
| Total, other adverse events | Placebo | 60 | 72 |
| Total, serious adverse events | Diclofenac (DIC075V) | 7 | 145 |
| Total, serious adverse events | Ketorolac | 4 | 60 |
| Total, serious adverse events | Placebo | 3 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29492863 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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