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Also known as DIC075V (intravenous diclofenac sodium), Voltaren, Voltarol, Cataflam, Zipsor
DIC075V · 2 trials · 2 indications
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.
Concomitant medications were medications that were taken concurrently on or after first dose of study drug.
Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes.
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Respiratory rate was measured after the participant had taken rest for 5 minutes.
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes.
Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category "Not Done" for participants with no wound assessment other than the reason 'missing' and category "Missing", where participants were missing for wound assessment.
Thrombophlebitis assessment evaluation was done using following grades: 0 equals to (=) no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Thrombophlebitis assessment evaluation was done using following grades: 0= no reaction, 1= tenderness along the vein, 2= continuous tenderness of pain with redness, 3= palpable swelling or thrombosis within length of cannula, 4= palpable swelling or thrombosis beyond the length of the cannula and 5= palpable swelling or thrombosis beyond the length of the cannula with overt infection.
Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion.
The primary ECG endpoint is the time-matched active drug-placebo difference in baseline-adjusted QTc interval using the Fridericia correction formula (QTcF). The QTcF is evaluated at the time point where the maximal baseline and placebo-adjusted value is observed. These measurements are consistent with ICH E14 guidance.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Experimental 1 | EXPERIMENTAL | DIC075V 37.5 mg |
| Experimental 2 | EXPERIMENTAL | DIC075V 75 mg |
| Active control | ACTIVE_COMPARATOR | Moxifloxacin hydrochloride 400 mg |
| Name | Type | Description |
|---|---|---|
| DIC075V (intravenous diclofenac sodium) | DRUG | multiple doses up to 5 days |
| DIC075V | DRUG | Four single dose treatments: * Placebo (normal saline) * Moxifloxacin (positive control) * DIC075V 37.5 mg * DIC075V 75 mg All subjects receive each of the 4 treatments. |
Inclusion Criteria: * abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days * Expected stay \> 48 hrs Exclusion Criteria: * bilirubin \> 2.5 mg/dl ...
DIC075V is an intravenous formulation of diclofenac sodium, a small molecule developed by Pfizer for the treatment of acute postoperative pain. It is also known as DIC075V (intravenous diclofenac sodium). The program includes a completed Phase 3 open-label safety study in patients with acute post-operative pain and a completed Phase 1 study in healthy subjects.
DIC075V is being studied for the treatment of acute postoperative pain in adults. Its Phase 3 trial enrolled 1,050 patients aged 18 years and older with acute post-operative pain in the United States. A separate Phase 1 study evaluated its effect on ventricular repolarization, specifically QTc intervals, in healthy subjects.
DIC075V is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating the intravenous diclofenac sodium formulation in postoperative pain and in a cardiac safety assessment of ventricular repolarization.
DIC075V has completed a Phase 3 trial, an open-label safety study in 1,050 patients with acute post-operative pain. It is an investigational product and is not approved. A Phase 1 crossover study evaluating its effect on QTc intervals in 70 healthy subjects has also been completed.
DIC075V has been studied in two completed trials. NCT00726388 was a Phase 3 open-label safety study of intravenous diclofenac sodium in 1,050 patients with acute post-operative pain. NCT01812538 was a Phase 1 four-way crossover study of 70 healthy subjects assessing the effect of DIC075V on QTc intervals and ventricular repolarization.
Yes. DIC075V is the same as DIC075V (intravenous diclofenac sodium). The code DIC075V refers to Pfizer's intravenous formulation of diclofenac sodium, a small molecule being evaluated for acute postoperative pain and assessed for its effect on ventricular repolarization.