Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Caldolor · 3 trials · 3 indications
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery \[variable since every surgery has a unique length of time even if it is the same procedure\] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| Normal Saline | PLACEBO_COMPARATOR | 250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period. |
| Intravenous ibuprofen | EXPERIMENTAL | 800 mg of intravenous ibuprofen diluted in 250 milliliters normal saline was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period. |
| Name | Type | Description |
|---|---|---|
| Caldolor | DRUG | 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours |
| Placebo | DRUG | Placebo |
| Normal Saline | OTHER | Placebo comparator |
Inclusion Criteria: 1. Patients with second and/or third degree thermal burns covering more than 10 percent total body surface area (including face) with anticipated hospital stay greater than 72 hours. 2. Adequate intravenous access 3. Have fever, documented by temperature greater than or equal to...
Caldolor is used for the treatment of pain, fever, and burns in hospitalized patients. It is an investigational small molecule being developed by Cumberland Pharmaceuticals Inc. (CPIX). Caldolor is currently in Phase 3 clinical development for these indications.
Caldolor is a small molecule that contains ibuprofen, a nonsteroidal anti-inflammatory drug. It works by inhibiting the COX enzymes, which reduces the production of prostaglandins that cause pain and fever. This mechanism helps manage pain and fever in hospitalized patients.
Caldolor is being developed by Cumberland Pharmaceuticals Inc., a biopharmaceutical company. The company's stock ticker is CPIX. Cumberland Pharmaceuticals is conducting clinical trials to evaluate Caldolor for the treatment of pain, fever, and burns.
Caldolor is in Phase 3 clinical development. It has completed three Phase 3 trials, including studies in pediatric patients with fever, adult orthopedic patients with pain, and burn patients. Caldolor is not yet approved by the FDA and remains investigational.
Caldolor has completed three Phase 3 clinical trials. These include NCT00225706 in hospitalized febrile pediatric patients, NCT00470600 in hospitalized adult orthopedic patients with pain, and NCT00606489 in hospitalized adult and pediatric burn patients. All trials are completed.
Caldolor is an intravenous formulation of ibuprofen. It is being studied for its ability to manage pain and fever in hospitalized patients who cannot take oral medications. The clinical trials evaluate Caldolor's efficacy and safety compared to placebo.