PainPhase 4NCT01334957

Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

A Phase 4 study testing Intravenous ibuprofen in people with Pain, run by Cumberland Pharmaceuticals at 22 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 preemptive treatment of postoperative pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
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: 300 participants
Where: 22 sitesUnited States
Study dates: Jun 2011to Jan 2013
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

Patients scheduled for surgery with anticipated need for postoperative analgesia

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

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Albany Medical Center
Albany, New York, 12208
Brigham and Women's Hospital
Boston, Massachusetts, 02115
State of New York Downstate Medical Center (SUNY)
Brooklyn, New York, 11203
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
RUSH Univ. Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Medical Center
Columbus, Ohio, 43201
Parkland Memorial
Dallas, Texas, 75235
Detroit Medical Center
Detroit, Michigan, 48201
Duke University Health System
Durham, North Carolina, 27710
Hendersonville Hospital/Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Univ. of Kansas Medical Center
Kansas City, Kansas, 66160
UC San Diego Regional Center
La Jolla, California, 92037
North Shore - Long Island Jewish Health System
Manhasset, New York, 11030
University of Miami Health System
Miami, Florida, 33136
Neurovations (Queen of the Valley Hospital)
Napa, California, 94558
Ochsner Medical Center
New Orleans, Louisiana, 70121-2483
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Sheridan Clinical Research
Plantation, Florida, 33324
North Mississippi Sports Medicine & Orthopaedic Clinic
Tupelo, Mississippi, 38801
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label, Surgical 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 preemptive treatment of postoperative pain.

Conditions: Pain
Being tested: Intravenous ibuprofen
Medical subject headings: Pain

What participants receive

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

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

Study groups in NCT01334957
Study group	Role	What they receive
Intravenous ibuprofen	Experimental	Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 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 Over 5-10 Minutes for the Reduction of Pain.
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first 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 Reduction of Post-operative Pain.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
Measured: 6 hours

Secondary outcomes (3)

To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
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 Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
The incidence of treatment-emergent 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 Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Visual Analog Scale (VAS) assessments following surgery. 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: 6 hours

Timeline

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

Jun 2011Jan 2013

First posted13 Apr 2011 (estimated)
Study startJun 2011
Primary completionDec 2012
Study completionJan 2013

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.
Publications (1)Papers the sponsor has linked to this study.
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: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01334957
Sponsor's protocol ID: CPI-CL-016
Status last verified: Feb 2024
First submitted: 12 Apr 2011
Last updated: 28 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13.
PubMed 25592331

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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen
ClinicalTrials.gov ID: NCT01334957
Acronym / sponsor ID: CPI-CL-016
Conditions: Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Dec 2012 (actual)
Study completion: Jan 2013 (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 preemptive treatment of postoperative pain.

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 (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 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)

Patients scheduled for surgery with anticipated need for postoperative analgesia

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: Caldolor800 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 Over 5-10 Minutes for the Reduction of Pain.
Time frame: 6 hours
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Time frame: 6 hours
The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen

3 secondary outcomes

To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
Time frame: 6 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Time frame: 6 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Time frame: 6 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
Intravenous Ibuprofen	300	300

Primary outcome: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.

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

Measure	Intravenous Ibuprofen n = 252
Value	8

Primary outcome: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.

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

Measure	Intravenous Ibuprofen n = 252
Value	49

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravenous Ibuprofen	8 of 300 (2.7%)	49 of 300 (16.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25592331Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13.

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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

22 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, run by Cumberland Pharmaceuticals at 22 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 Over 5-10 Minutes for the Reduction of Pain. (time frame: 6 hours). The study lists 2 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 NCT01334957, 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 28 Feb 2024.