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This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.
The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | intravenous diclofenac dosage level 1 |
|
| B | Experimental | intravenous diclofenac dosage level 2 |
|
| C | Active Comparator | intravenous ketorolac |
|
| D | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Diclofenac (DIC075V) | Drug | Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of the pain intensity differences (SPID) over the 0-48 hour time interval. | 0-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| SPID over the 0-24 hour interval | 0-24 hours | |
| Other measures of pain relief | Multiple |
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Inclusion Criteria:
Exclusion Criteria:
Additional Inclusion/Exclusion Criteria May Apply
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| Name | Affiliation | Role |
|---|---|---|
| Javelin Pharmaceuticals | Javelin Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | United States | ||
| Eliza Coffee Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29492863 | Derived | Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3. | |
| 22886837 | Derived | Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10. |
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| Intravenous Ketorolac | Drug | Intravenous Ketorolac |
|
| placebo | Drug | placebo |
|
| Florence |
| Alabama |
| 35630 |
| United States |
| Drug Research and Analysis Corp. | Montgomery | Alabama | 36106 | United States |
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States |
| Teton Research / Parkview Surgical | Little Rock | Arkansas | 72205 | United States |
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States |
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33437 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Clinical Research Services | Bismarck | North Dakota | 58501 | United States |
| Clinical Research Center | Austin | Texas | 78705 | United States |
| Memorial Hermann Healthcare System - Memorial City Hospital | Houston | Texas | 77024 | United States |
| Clinical Research Center | San Marcos | Texas | 78666 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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