Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 investigational small molecule being developed by Pfizer for the treatment of acute postoperative pain. It is an intravenous formulation of diclofenac sodium intended to manage pain following surgery. The drug is currently in Phase 3 clinical development and has not been approved by the FDA.
DIC075V is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting cyclooxygenase enzymes, reducing prostaglandin synthesis to alleviate pain and inflammation. As a diclofenac sodium formulation, it targets COX-1 and COX-2 pathways to provide analgesic effects in postoperative settings.
DIC075V is being developed by Pfizer, Inc., a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of this intravenous diclofenac sodium formulation for acute postoperative pain.
DIC075V is in Phase 3 clinical development for acute postoperative pain. A Phase 3 safety study has been completed, and the drug remains investigational. It is not yet FDA approved, and further clinical evaluation is required before regulatory submission.
DIC075V has one completed Phase 3 trial, NCT00726388, an open-label safety study in 1050 patients with acute postoperative pain. A separate Phase 1 study, NCT01812538, evaluated its effect on QTc intervals in healthy subjects. Both trials were conducted in the United States.
DIC075V is an intravenous formulation of diclofenac sodium, a well-known NSAID. While it shares the active ingredient with oral diclofenac products, DIC075V is a specific investigational formulation designed for intravenous administration in postoperative pain management. It is not yet commercially available.