Phase 3
N=277
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00507026 ↗Enrolled (actual)
277
Serious AEs
5.1%
Results posted
Oct 2021
Primary outcome: Primary: Sum of the Pain Intensity Differences (SPID) Over 24 Hours — 577.0; 563.2; 28.0 mm*hours — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IV Diclofenac (Drug); IV ketorolac (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of the Pain Intensity Differences (SPID) Over 24 Hours |
577.0; 563.2; 28.0 | <0.0001 sig |
| PRIMARY Sum of the Pain Intensity Differences (SPID) Over 48 Hours |
1527.5; 1371.8; 400.4 | <0.0001 sig |
| PRIMARY Sum of the Pain Intensity Differences (SPID) Over 72 Hours |
2592.1; 2312.1; 836.8 | <0.0001 sig |
| PRIMARY Sum of the Pain Intensity Differences (SPID) Over 96 Hours |
3711.3; 3331.9; 1337.8 | <0.0001 sig |
| PRIMARY Sum of the Pain Intensity Differences (SPID) Over 120 Hours |
4835.6; 4359.1; 1840.5 | <0.0001 sig |
| SECONDARY Pain Intensity Differences (PID) Over Time |
5.2; 3.2; 1.2; 9.1; 5.5; 2.4 | — |
| SECONDARY Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity |
13.8; 10.0; 8.3; 43.4; 35.0; 25.0 | — |
| SECONDARY Total Pain Relief (TOTPAR) |
1177.6; 1065.4; 484.7; 2768.3; 2453.8; 1327.9 | — |
| SECONDARY Visual Analog Pain Relief Values Over the Time |
21.9; 17.9; 15.3; 27.1; 23.6; 19.0 | — |
| SECONDARY Time From Administration of Study Drug to Administration of Rescue Medication |
220.0; 137.0; 51.0 | — |
| SECONDARY Cumulative Amount of Rescue Medication |
9.4; 11.5; 16.0; 11.1; 15.5; 19.0 | — |
| SECONDARY Number of Participants According to Frequency of Use of Rescue Medication |
39; 17; 4; 26; 6; 7 | — |
| SECONDARY Participant Global Evaluation Over Time |
2.6; 2.4; 1.1; 2.9; 2.6; 1.9 | — |
| SECONDARY Time to Perceptible Relief |
10.0; 14.4; 15.0 | — |
| SECONDARY Time to Meaningful Relief |
41.6; 42.5; NA | — |
Summary
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00507026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.