PainPhase 4NCT01334944

Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

A Phase 4 study testing Intravenous ibuprofen in people with Pain and Fever, run by Cumberland Pharmaceuticals at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Fever
What is being tested?: Intravenous ibuprofen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 13 sitesUnited States
Study dates: Jun 2011to Oct 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Pain: Patients with baseline Visual Analog Scale assessment >3, -and/or- Fever: Patients with temperature >101°F.

Who cannot join

Patients with inadequate IV access
Patients <18 years of age
History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
Active hemorrhage or clinically significant bleeding
Pregnant or nursing
Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
Inability 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 [IRB]), and agree to abide by the study restrictions
Refusal to provide written authorization for use and disclosure of protected health information

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Grady
Atlanta, Georgia, 30303
Beth Israel Deaconnes MC
Boston, Massachusetts, 02215
The University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
Fairview
Cleveland, Ohio, 44111
The Ohio State University Medical Center
Columbus, Ohio, 43210
Danbury
Danbury, Connecticut, 06810
Duke University Medical Center
Durham, North Carolina, 27710
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401-1020
University of Miami - Miller School of Medicine
Miami, Florida, 33136
Columbia
New York, New York, 10032
UCSD
San Diego, California, 92103
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Lankenau
Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.

The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.

Conditions: Pain, Fever
Being tested: Intravenous ibuprofen
Keywords: Pain, Fever
Medical subject headings: Pain, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous ibuprofenDrug
Also called Caldolor
400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Study groups in NCT01334944
Study group	Role	What they receive
Intravenous ibuprofen	Experimental	Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Receives: Drug: Intravenous ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Measured: 6 hours
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
Measured: 6 hours
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting
The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
Measured: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
Measured: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
Measured: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
Measured: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
Measured: 1 hour

Secondary outcomes (4)

To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration
Measured: 4 hours
To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).
The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.
Measured: 4 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
The incidence of treatment-emergent serious adverse events occurring through extended dosing.
Measured: 24 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
The incidence of treatment-emergent adverse events occurring through extended dosing.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Oct 2012

First posted13 Apr 2011 (estimated)
Study startJun 2011
Primary completionSep 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01334944
Sponsor's protocol ID: CPI-CL-015
Status last verified: Jul 2016
First submitted: 12 Apr 2011
Last updated: 5 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.
ClinicalTrials.gov ID: NCT01334944
Acronym / sponsor ID: CPI-CL-015
Conditions: Pain, Fever
Keywords: Pain, Fever
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Sep 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 13 Apr 2011 (estimated)
Results: Posted 23 Jun 2014

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 determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intravenous ibuprofen	Experimental	Drug: Intravenous ibuprofenIntravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Pain: Patients with baseline Visual Analog Scale assessment >3, -and/or- Fever: Patients with temperature >101°F.

Key exclusion criteria (8 listed)

Patients with inadequate IV access
Patients <18 years of age
History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
Active hemorrhage or clinically significant bleeding
Pregnant or nursing

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
Intravenous ibuprofenAlso: Caldolor400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes	Drug	Intravenous ibuprofen

Primary outcome

To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
Time frame: 6 hours
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
Time frame: 6 hours
The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting
Time frame: 1 hour
The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
Time frame: 1 hour
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
Time frame: 1 hour
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
Time frame: 1 hour
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
Time frame: 1 hour
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).

4 secondary outcomes

To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
Time frame: 4 hours
To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).
Time frame: 4 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
Time frame: 24 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
Time frame: 24 hours

Results and safety

Results posted to the registry on 23 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fever	11	11
Pain	139	139

Primary outcome: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.

Time frame: 6 hours. Number. Unit: Number of Serious Adverse Events

Measure	Fever n = 11	Pain n = 139
Value	0	0

Primary outcome: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.

Time frame: 6 hours. Number. Unit: Number of Events

Measure	Fever n = 1	Pain n = 96
Value	0	16

Population analysed: This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen

Primary outcome: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting

Time frame: 1 hour. Mean (95% Confidence Interval). Unit: Degree Fahrenheit

Measure	Fever n = 11	Pain n = 139
Value	-0.9 (-2.7 to 0.3)	-0.1 (-3.2 to 1.6)

Primary outcome: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.

Time frame: 1 hour. Mean (95% Confidence Interval). Unit: Beats Per Minute

Measure	Fever n = 11	Pain n = 139
Value	-2 (-16 to 8)	-1 (-34 to 62)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fever	0 of 11 (0%)	0 of 11 (0%)	Not reported
Pain	1 of 139 (0.7%)	43 of 139 (30.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Art P Wheeler, M.D. study director

Cumberland Pharmaceuticals

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravenous ibuprofen in people with Pain and Fever, run by Cumberland Pharmaceuticals at 13 sites in United States.

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 1 inclusion and 8 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 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. (time frame: 6 hours). The study lists 7 primary outcomes in all. 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 NCT01334944.

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 5 Jul 2023.