FeverPhase 3NCT00225706
A Study of Caldolor in Hospitalized Febrile Pediatric Patients
A Phase 3 study testing Caldolor in people with Fever, run by Cumberland Pharmaceuticals at 3 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Fever
- What is being tested?
- Caldolor
- How many people
- Not given
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2005to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be hospitalized
- Be between 6 months and 17 years of age, inclusive
- Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC) (The preferred method of temperature measurement is core. The route of temperature measurement used immediately before randomization should be used immediately before dosing and for all temperature measurements during the Treatment Period.)
- Have written informed consent provided by legal parent, guardian, or authorized agent, and have same agree to abide by the study restrictions and to return for the required assessments (Where appropriate, participants of appropriate intellectual maturity should personally provide written informed assent; age of assent may be determined by Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) or be consistent with local legal requirements.)
Who cannot join
- Have inadequate intravenous access
- Have received antipyretic drug therapy within 8 hours before dosing
- Be pregnant or nursing
- Have any history of allergy or hypersensitivity to NSAIDs, aspirin, APAP, or any component of Caldolor or APAP.
- Have a history of severe head trauma that required the current hospitalization, had intracranial surgery or stroke within the previous 30 days, or have any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
- Have a history of febrile convulsion or have a sibling with a history of febrile convulsion
Show all 18Show fewer
- Have a history of congenital bleeding diatheses (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction, including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
- Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks, unless definitive surgery has been performed
- Have platelet count less than 30,000/mm3
- Be receiving full dose anticoagulation therapy (Prophylaxis with subcutaneous heparin is acceptable.)
- Have fever secondary to blood or drug reaction
- Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
- Be receiving ongoing or imminent treatment with corticosteroids
- Have neurogenic fever
- Be on dialysis, have oliguria or calculated creatinine clearance of less than 70 mL/min (calculated using the Schwartz formula), have impaired renal function, be receiving nephrotoxic drugs, or be expected to be unable to tolerate the extra fluid required for administration of CTM
- Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved
- Have received another investigational drug within the past 30 days
- Be otherwise unsuitable for the study, in the opinion of the Investigator
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Vanderbilt University Children's Hospital
Nashville, Tennessee, 37203
About this study
Official title: Efficacy and Safety Study of Caldolor in Hospitalized Febrile Pediatric Patients
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]).
- Conditions
- Fever
- Being tested
- Caldolor
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaldolorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225706
- Sponsor's protocol ID
- CPI-CL-005
- Status last verified
- Oct 2007
- First submitted
- 22 Sep 2005
- Last updated
- 12 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Caldolor in Hospitalized Febrile Pediatric Patients
- ClinicalTrials.gov ID
- NCT00225706
- Acronym / sponsor ID
- CPI-CL-005
- Conditions
- Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Be hospitalized
- Be between 6 months and 17 years of age, inclusive
- Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC) (The preferred method of temperature measurement is core. The route of temperature measurement used immediately before randomization should be used immediately before dosing and for all temperature measurements during the Treatment Period.)
- Have written informed consent provided by legal parent, guardian, or authorized agent, and have same agree to abide by the study restrictions and to return for the required assessments (Where appropriate, participants of appropriate intellectual maturity should personally provide written informed assent; age of assent may be determined by Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) or be consistent with local legal requirements.)
Key exclusion criteria (18 listed)
- Have inadequate intravenous access
- Have received antipyretic drug therapy within 8 hours before dosing
- Be pregnant or nursing
- Have any history of allergy or hypersensitivity to NSAIDs, aspirin, APAP, or any component of Caldolor or APAP.
- Have a history of severe head trauma that required the current hospitalization, had intracranial surgery or stroke within the previous 30 days, or have any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caldolor | Drug | – |
Primary outcome
Temperature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2010.
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caldolor in people with Fever, run by Cumberland Pharmaceuticals at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Panama, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2010.