Phase 3
Completed N=1,050
An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
Pain, Postoperative
Source: ClinicalTrials.gov NCT00726388 ↗
Enrolled (actual)
1,050
Serious AEs
7.5%
Results posted
Oct 2021
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 823; 73 Participants
◆ Published Evidence
Emerging
7citations · ~1 / year
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Summary
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.
Linked Publications
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Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
823; 73 | — |
| PRIMARY Number of Participants Who Took at Least 1 Concomitant Medication |
971 | — |
| PRIMARY Number of Participants With Abnormal Urinalysis Findings |
2 | — |
| PRIMARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline |
14 | — |
| PRIMARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Study Discharge/Early Termination |
13 | — |
| PRIMARY Change From Baseline in Blood Pressure at Study Discharge/Early Termination |
-2.2; -0.5 | — |
| PRIMARY Change From Baseline in Blood Pressure at Clinic Follow-up Visit |
0.2; 4.4 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Study Discharge/Early Termination |
1.3 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Clinic Follow-up Visit |
1.0 | — |
| PRIMARY Change From Baseline in Heart Rate at Study Discharge/Early Termination |
3.8 | — |
| PRIMARY Change From Baseline in Heart Rate at Clinic Follow-up Visit |
2.4 | — |
| PRIMARY Number of Participants With Wound Assessment at Study Discharge/Early Termination |
40; 154; 727; 11; 0; 33 | — |
| PRIMARY Number of Participants With Thrombophlebitis Assessment Evaluation at Baseline |
960; 3; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Thrombophlebitis Assessment Evaluation at Study Discharge/Early Termination |
925; 26; 3; 3; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Physical Examination Abnormalities at Screening |
8; 3; 7; 1; 2; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Physical Examination Abnormalities at Clinic Follow-up Visit |
8; 13; 2; 1; 0; 0 | — |
Eligibility Criteria
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
- prothrombin time is > 20% above the upper limit of normal
- serum creatinine is > 1.9 mg/dl at screening.
- known allergy or hypersensitivity to diclofenac, other NSAIDs,
Data sourced from ClinicalTrials.gov (NCT00726388) and the linked publication. 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. Informational only — not medical advice.