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Also known as IV Diclofenac, Diclofenac SR
Diclofenac · 1 trial · 1 indication
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | DIC075V (IV diclofenac) |
| B | ACTIVE_COMPARATOR | IV Ketorolac |
| C | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| IV Diclofenac | DRUG | IV Diclofenac q6h |
| IV ketorolac | DRUG | IV ketorolac q6h |
| Placebo | DRUG | Placebo q6h |
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...
Diclofenac is a small molecule drug being developed for the treatment of postoperative pain. It is designed to relieve pain following surgical procedures, including elective orthopedic surgery. The clinical program has evaluated it in adult patients aged 18 years and older in the United States.
Diclofenac targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. By inhibiting PTGS2 and PTGS1, Diclofenac interferes with the pathways these targets are involved in, which underlies its activity in pain management.
Diclofenac is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company responsible for advancing the Diclofenac program, including the intravenous formulation studied in postoperative pain.
Diclofenac is in Phase 3 clinical development for postoperative pain. It is an investigational agent and is not approved for this use. The Phase 3 trial in the program has been completed, and no trials are currently listed as active.
Diclofenac has been studied in one completed Phase 3 trial, NCT00507026, titled Efficacy and Safety of IV Diclofenac (DIV075V) for Pain After Elective Orthopedic Surgery. The trial enrolled 277 participants in the United States, was randomized, double blind, and placebo controlled, and included adults aged 18 years and older.
Yes. Diclofenac is also known as IV Diclofenac and Diclofenac SR. These names refer to the same drug asset, with the IV designation reflecting the intravenous formulation evaluated in the postoperative pain Phase 3 trial. Readers searching for IV Diclofenac or Diclofenac SR are looking at the same compound.