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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01131000




Registration number
NCT01131000
Ethics application status
Date submitted
24/05/2010
Date registered
26/05/2010
Date last updated
26/05/2010

Titles & IDs
Public title
Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients
Scientific title
A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients
Secondary ID [1] 0 0
CPI-CL-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fever 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ibuprofen
Treatment: Drugs - Ibuprofen
Treatment: Drugs - Ibuprofen
Other interventions - Normal Saline

Experimental: Ibuprofen -

Placebo comparator: Saline - Normal Saline


Treatment: Drugs: Ibuprofen
Intravenous ibuprofen, 100 mg, Single-dose

Treatment: Drugs: Ibuprofen
Intravenous ibuprofen, 200mg, single dose

Treatment: Drugs: Ibuprofen
Intravenous ibuprofen, 400 mg, Single-dose

Other interventions: Normal Saline
Normal Saline, 100 ml, Single-dose
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.
Timepoint [1] 0 0
4 hours

Eligibility
Key inclusion criteria
1. Be hospitalized
2. Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC)
3. Have adequate intravenous access
4. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Be less than 18 years of age
2. Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing
3. Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors
4. Be pregnant or nursing
5. 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
6. Weigh less than 40 kg
7. 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
8. Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
9. Have a platelet count less than 30,000/mm3
10. Be receiving full dose anticoagulation therapy
11. Have fever secondary to blood or drug reaction
12. Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
13. 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.)
14. Have neurogenic fever
15. Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL, or be receiving nephrotoxic drugs
16. Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved
17. Have received another investigational drug within the past 30 days
18. Become afebrile (temperature below 101.0ºF [38.3ºC]) before dosing and not redevelop fever entry criteria during this hospitalization
19. Be otherwise unsuitable for the study, in the opinion of the Investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2005
Sample size
Target
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Newcastle Mater Misericordiae Hospital - New Lambton
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Thailand
State/province [6] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cumberland Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.
Trial website
https://clinicaltrials.gov/study/NCT01131000
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Gordon Bernard, M.D.
Address 0 0
Cumberland Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01131000