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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR CALDOLOR

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Clinical Trials for Caldolor

Trial ID Title Status Sponsor Phase Summary
NCT00225706 A Study of Caldolor in Hospitalized Febrile Pediatric Patients Completed Cumberland Pharmaceuticals Phase 3 The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a target temperature of 98.6ºF [37.0ºC]).
NCT00225732 Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients Completed Cumberland Pharmaceuticals Phase 3 The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery
NCT00470600 Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients Completed Cumberland Pharmaceuticals Phase 3 The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.
NCT00606489 Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients Completed Cumberland Pharmaceuticals Phase 3 The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.
NCT01200069 IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia Terminated Rutgers, The State University of New Jersey Phase 4 Post-procedure myalgia (muscle ache) is a well-known and common complication of Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exercise. The myalgias typically begin shortly after the procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of patients considered prevention significant and would be willing to pay a median of $33 out of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a further financial burden if these patients are unable to return to work or resume previous daily activities in the days following the procedure. An agent that could treat and possibly even prevent these myalgias has the potential to be very beneficial to these patients. IV ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever.
NCT01297829 Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics Unknown status Cumberland Pharmaceuticals Phase 3 Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug. The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Caldolor

Condition Name

Condition Name for Caldolor
Intervention Trials
Pain 7
Fever 3
Pain, Postoperative 1
Depression, Myalgia 1
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Condition MeSH

Condition MeSH for Caldolor
Intervention Trials
Pain, Postoperative 3
Pituitary Neoplasms 1
Myalgia 1
Pituitary Diseases 1
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Clinical Trial Locations for Caldolor

Trials by Country

Trials by Country for Caldolor
Location Trials
United States 49
India 3
South Africa 2
Korea, Republic of 2
Panama 1
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Trials by US State

Trials by US State for Caldolor
Location Trials
Ohio 4
California 4
Florida 4
Pennsylvania 3
New York 3
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Clinical Trial Progress for Caldolor

Clinical Trial Phase

Clinical Trial Phase for Caldolor
Clinical Trial Phase Trials
Phase 4 8
Phase 3 5
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Caldolor
Clinical Trial Phase Trials
Completed 10
Active, not recruiting 2
Unknown status 2
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Clinical Trial Sponsors for Caldolor

Sponsor Name

Sponsor Name for Caldolor
Sponsor Trials
Cumberland Pharmaceuticals 11
Columbia University 1
St. Barnabas Medical Center 1
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Sponsor Type

Sponsor Type for Caldolor
Sponsor Trials
Industry 11
Other 8
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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Queensland Health
Farmers Insurance
Cantor Fitzgerald
Argus Health
Federal Trade Commission
Merck
Accenture
US Department of Justice

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