FeverPhase 3NCT01131000
Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients
A Phase 3 study testing Ibuprofen and Normal Saline in people with Fever, run by Cumberland Pharmaceuticals at 11 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever
- What is being tested?
- Ibuprofen and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Jun 2002to Aug 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be hospitalized
- Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC)
- Have adequate intravenous access
- Have the ability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board), and agree to abide by the study restrictions and to return for the required assessments
Who cannot join
- Be less than 18 years of age
- Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing
- Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors
- Be pregnant or nursing
- Have a history of severe head trauma that required current hospitalization, intracranial surgery, or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
- Weigh less than 40 kg
Show all 19Show 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 a platelet count less than 30,000/mm3
- Be receiving full dose anticoagulation therapy
- 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 treatment with corticosteroids (Patients who are expected to receive corticosteroids during the Treatment Period or through Hour 120 of the Post-treatment Period are not eligible.)
- Have neurogenic fever
- Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL, or be receiving nephrotoxic drugs
- 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
- Become afebrile (temperature below 101.0ºF [38.3ºC]) before dosing and not redevelop fever entry criteria during this hospitalization
- Be otherwise unsuitable for the study, in the opinion of the Investigator
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States8 sites
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
Ben Taub General Hospital
Houston, Texas, 77030
Methodist Healthcare - University Hospital
Memphis, Tennessee, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Skyline Medical Center
Nashville, Tennessee, 37207
Orlando Regional Medical Center
Orlando, Florida, 32806
Barnes Jewish Hospital
St Louis, Missouri, 63110
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Australia2 sites
Flinders Medical Centre
Adelaide, South Australia
Newcastle Mater Misericordiae Hospital
New Lambton, New South Wales, 2305
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients
The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.
Read the detailed description
The primary objective of this study is to evaluate the efficacy of a single 400 mg dose of intravenous ibuprofen on reducing fever greater than or equal to 101.0ºF (38.3ºC), as compared with the efficacy of parallel placebo treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Intravenous ibuprofen, 100 mg, Single-dose
IbuprofenDrug
Intravenous ibuprofen, 200mg, single dose
IbuprofenDrug
Intravenous ibuprofen, 400 mg, Single-dose
Normal SalineOther
Also called 0.9 % NaCL; 0.9 % Sodium Chloride
Normal Saline, 100 ml, Single-dose
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen |
| Saline | Placebo comparator | Normal Saline Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJun 2002
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gordon Bernard, M.D., Study chair, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131000
- Sponsor's protocol ID
- CPI-CL-004
- Status last verified
- May 2010
- First submitted
- 24 May 2010
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morris PE, Promes JT, Guntupalli KK, Wright PE, Arons MM. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30.
PubMed 20591173
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients
- ClinicalTrials.gov ID
- NCT01131000
- Acronym / sponsor ID
- CPI-CL-004
- Conditions
- Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 26 May 2010 (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 is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.
Detailed description
The primary objective of this study is to evaluate the efficacy of a single 400 mg dose of intravenous ibuprofen on reducing fever greater than or equal to 101.0ºF (38.3ºC), as compared with the efficacy of parallel placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen |
| Saline | Placebo comparator | Other: Normal SalineNormal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be hospitalized
- Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC)
- Have adequate intravenous access
- Have the ability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board), and agree to abide by the study restrictions and to return for the required assessments
Key exclusion criteria (19 listed)
- Be less than 18 years of age
- Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing
- Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors
- Be pregnant or nursing
- Have a history of severe head trauma that required current hospitalization, intracranial surgery, or stroke within the previous 30 days, or 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 |
|---|---|---|
| IbuprofenIntravenous ibuprofen, 100 mg, Single-dose | Drug | Ibuprofen |
| IbuprofenIntravenous ibuprofen, 200mg, single dose | Drug | Ibuprofen |
| IbuprofenIntravenous ibuprofen, 400 mg, Single-dose | Drug | Ibuprofen |
| Normal SalineAlso: 0.9 % NaCL; 0.9 % Sodium ChlorideNormal Saline, 100 ml, Single-dose | Other | Saline |
Primary outcome
Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.
Time frame: 4 hours
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 26 May 2010.
- Derived from this study: PubMed 20591173Morris PE, Promes JT, Guntupalli KK, Wright PE, Arons MM. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30.
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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.
Gordon Bernard, M.D. study chair
Cumberland Pharmaceuticals
11 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 Ibuprofen and Normal Saline in people with Fever, run by Cumberland Pharmaceuticals at 11 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 19 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 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, Thailand. 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. Some participants in this study may receive a placebo. 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?
Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01131000, which also lists 1 linked publication.
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 26 May 2010.