An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

Primary outcomes

1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

   Time frame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)

   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.

2. Number of Participants Who Took at Least 1 Concomitant Medication

   Time frame: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)

   Concomitant medications were medications that were taken concurrently on or after first dose of study drug.

3. Number of Participants With Abnormal Urinalysis Findings

   Time frame: Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)

   Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator.

4. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline

   Time frame: Baseline (Day 1, immediately before dosing)

   12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.

5. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination

   Time frame: Study discharge/early termination (maximum up to Day 5)

   12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion.

6. Change From Baseline in Blood Pressure at Study Discharge/Early Termination

   Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)

   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.

7. Change From Baseline in Blood Pressure at Clinic Follow-up Visit

   Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

   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.

8. Change From Baseline in Respiratory Rate at Study Discharge/Early Termination

   Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)

   Respiratory rate was measured after the participant had taken rest for 5 minutes.

9. Change From Baseline in Respiratory Rate at Clinic Follow-up Visit

   Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

   Respiratory rate was measured after the participant had taken rest for 5 minutes.

10. Change From Baseline in Heart Rate at Study Discharge/Early Termination

    Time frame: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)

    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.

11. Change From Baseline in Heart Rate at Clinic Follow-up Visit

    Time frame: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

    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.

12. Number of Participants With Wound Assessment at Study Discharge/Early Termination

    Time frame: Study discharge/early termination (maximum up to Day 5)

    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.

13. Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline

    Time frame: Baseline (Day 1, immediately before dosing)

    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.

14. Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination

    Time frame: Study discharge/early termination (maximum up to Day 5)

    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.

15. Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening

    Time frame: Screening (0 to 21 days prior to surgery)

    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.

16. Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit

    Time frame: Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)

    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.