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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR CALDOLOR


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All Clinical Trials for Caldolor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00225706 ↗ A Study of Caldolor in Hospitalized Febrile Pediatric Patients Completed Cumberland Pharmaceuticals Phase 3 2005-10-01 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 2005-01-01 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 2007-05-01 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 2007-11-01 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 2010-07-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Caldolor

Condition Name

Condition Name for Caldolor
Intervention Trials
Pain 8
Fever 3
Arthroscopic Knee Surgery 1
Impacted Wisdom Teeth 1
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Condition MeSH

Condition MeSH for Caldolor
Intervention Trials
Pain, Postoperative 5
Fever 3
Hyperthermia 2
Pancreatitis 1
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Clinical Trial Locations for Caldolor

Trials by Country

Trials by Country for Caldolor
Location Trials
United States 56
Korea, Republic of 3
India 3
South Africa 2
Panama 1
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Trials by US State

Trials by US State for Caldolor
Location Trials
Florida 5
Ohio 4
New York 4
Pennsylvania 4
Texas 4
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Clinical Trial Progress for Caldolor

Clinical Trial Phase

Clinical Trial Phase for Caldolor
Clinical Trial Phase Trials
Phase 4 11
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Caldolor
Clinical Trial Phase Trials
Completed 16
Terminated 4
Unknown status 3
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Clinical Trial Sponsors for Caldolor

Sponsor Name

Sponsor Name for Caldolor
Sponsor Trials
Cumberland Pharmaceuticals 11
St. Joseph's Hospital and Medical Center, Phoenix 2
Rutgers, The State University of New Jersey 1
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Sponsor Type

Sponsor Type for Caldolor
Sponsor Trials
Other 16
Industry 11
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Caldolor (Ibuprofen Injection): Clinical Trials, Market Analysis, and Projections

Introduction

Caldolor, an intravenous formulation of ibuprofen, has been a significant player in the pain management market, particularly in the hospital setting. Recent clinical trials and market analyses have provided compelling evidence of its safety, efficacy, and potential for market growth.

Clinical Trials and Safety Profile

Adult Population

A recent real-world study published in Frontiers of Pain Research compared Caldolor to ketorolac in over 150,000 patients. The study found that Caldolor was associated with a 45% reduction in renal dysfunction and a 78% decrease in hematuria rates in adults compared to ketorolac. Additionally, Caldolor showed fewer gastrointestinal complications, headaches, nausea, and abdominal pain[1][4].

Pediatric Population

The same study also analyzed pediatric patients and found that Caldolor was associated with a 51-65% lower rate of adverse drug reactions (ADRs), including headache and nausea. This data is particularly valuable given the limited treatment options for pain management in pediatric patients[1][4].

FDA Approval for Infants

In 2023, the FDA approved the expanded labeling of Caldolor to include its use in infants from three months to six months of age for the treatment of pain and fever. This approval was based on a multi-center trial involving hospitalized infants, further solidifying Caldolor's safety profile across various age groups[3].

Market Analysis

Current Market Position

Cumberland Pharmaceuticals, the manufacturer of Caldolor, has seen robust growth in recent quarters. The company reported a 16% increase in net revenue to $9.9 million in Q2 2024, with Caldolor contributing $0.8 million to this total. The positive clinical trial results and expanded FDA approvals are expected to boost Caldolor's market position and increase its adoption among healthcare providers[5].

Competitive Advantage

The study comparing Caldolor to ketorolac highlights its superior safety profile and improved healthcare resource utilization. This includes fewer emergency room visits, outpatient visits, and shorter hospital stays. These findings position Caldolor as a cost-effective alternative to ketorolac, which could drive increased adoption and potentially expand Cumberland's market share in the injectable pain management segment[1][4].

Market Projections

Given the positive study results and FDA designations, Cumberland Pharmaceuticals is optimistic about future prospects. The company expects continued revenue growth and positive cash flow, driven in part by the enhanced market position of Caldolor. The expansion of coverage for other Cumberland products, such as Kristalose, and progress in international markets for Vibativ, further support the company's growth trajectory[2][5].

Healthcare Resource Utilization

Reduced Hospital Readmissions

Caldolor's impact on healthcare resource utilization is significant. The study showed that patients treated with Caldolor experienced decreased emergency room and outpatient visits, as well as shorter hospital stays. This reduction in healthcare resource utilization can lead to potential savings for healthcare systems through decreased hospital readmissions and shortened treatment times[1][4].

Cost-Effectiveness

The cost-effectiveness of Caldolor is a key factor in its market appeal. By reducing the need for additional medical interventions and shortening hospital stays, Caldolor can help healthcare systems manage costs more efficiently. This is particularly important in cost-sensitive healthcare environments where resource optimization is crucial[1][4].

Investor Perspective

Enhanced Reimbursement Rates

The peer-reviewed evidence from the recent study strengthens Caldolor's competitive position and could lead to improved reimbursement rates. This is significant for investors, as better reimbursement rates can directly impact revenue and market penetration, particularly in environments where cost is a critical factor[2].

Market Penetration

The positive clinical trial results and expanded FDA approvals are expected to increase investor confidence in Cumberland Pharmaceuticals. As the company continues to expand its product portfolio and enhance its market position, investors can anticipate potential growth in both revenue and stock performance[2][5].

Key Takeaways

  • Superior Safety Profile: Caldolor is associated with a reduced incidence of adverse drug reactions and improved healthcare utilization compared to ketorolac.
  • Expanded FDA Approvals: Recent approvals include the use of Caldolor in infants, further expanding its market reach.
  • Cost-Effectiveness: Reduced healthcare resource utilization and shorter hospital stays make Caldolor a cost-effective option.
  • Market Growth: Positive clinical trial results and FDA designations are expected to boost market position and increase adoption.
  • Investor Confidence: Enhanced reimbursement rates and improved market penetration are likely to increase investor confidence.

FAQs

What are the key findings of the recent study comparing Caldolor to ketorolac?

The study found that Caldolor was associated with a 45% reduction in renal dysfunction and a 78% decrease in hematuria rates in adults, and a 51-65% lower rate of adverse drug reactions in pediatric patients compared to ketorolac[1][4].

What is the current market position of Caldolor?

Caldolor is positioned as a superior alternative to ketorolac due to its safety profile and improved healthcare resource utilization, which could drive increased adoption and expand Cumberland's market share[1][4].

How has the FDA approval for infants impacted Caldolor?

The FDA approval for infants from three months to six months of age has expanded Caldolor's market reach and solidified its safety profile across various age groups[3].

What are the implications for healthcare resource utilization?

Caldolor's use is associated with decreased emergency room and outpatient visits, as well as shorter hospital stays, leading to potential savings for healthcare systems[1][4].

How might the recent study results affect investor confidence?

The positive clinical trial results and expanded FDA approvals are expected to strengthen Caldolor's competitive position, leading to improved reimbursement rates and increased investor confidence[2][5].

Sources

  1. Stock Titan: New Study Compares Caldolor® (ibuprofen injection) to ketorolac.
  2. Tickernerd: Cumberland Pharmaceuticals (CPIX) Stock Forecast & Price Target.
  3. Pharmaceutical Technology: FDA approves Cumberland's therapy for fever, pain in infants.
  4. PR Newswire: New Study Compares Caldolor® (ibuprofen injection) to ketorolac.
  5. Investing.com: Earnings call: Cumberland Pharmaceuticals sees robust Q2 growth.

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