NCT00225732

Brief Summary

The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P50-P75 for phase_3 pain

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3 pain

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

September 15, 2011

Completed
Last Updated

June 22, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

September 22, 2005

Results QC Date

April 1, 2011

Last Update Submit

May 17, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery

    Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery

    24 Hours

Study Arms (2)

intravenous ibuprofen

ACTIVE COMPARATOR
Drug: Intravenous ibuprofen

normal saline

PLACEBO COMPARATOR
Other: Normal saline as placebo comparator

Interventions

Normal saline as placebo comparatorOTHER

250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)

Also known as: NS
normal saline
Intravenous ibuprofenDRUG

800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)

Also known as: Caldolor
intravenous ibuprofen

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for elective abdominal hysterectomy surgery with anticipated need for post-operative I.V. morphine analgesia with anticipated use of ≥ 24 hours.
  • Adequate IV access
  • Anticipated hospital stay ≥ 24 hours

You may not qualify if:

  • Be unable to make a reliable self-report of pain intensity to pain relief
  • Less than 18 years of age
  • Greater than 70 years of age
  • Use of NSAIDs within 12 hours prior to dosing
  • Use of analgesics, muscle relaxants and sedatives less than 24 hours prior to CTM administration with the following exceptions: paracetamol (acetaminophen) can be administered until 6 hours prior to surgery; tramadol can be administered until midnight the evening prior to surgery; muscle relaxants working at the neuromuscular junction used for intubation and/or anesthesia administration for the surgical procedure prior to CTM administration; and sedatives (i.e., midazolam) used as a co-induction agent for the surgical procedure prior to CTM administration
  • Patients taking warfarin, lithium, combination of ACE-inhibitors and furosemide
  • Patients with anemia (active clinically significant) and/or a history or evidence of asthma or heart failure
  • History of allergy or hypersensitivity to any component of Caldolor, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
  • Pregnant or nursing
  • 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 CNS mass lesion
  • Weigh less than 30kg
  • Have a history of congenital bleeding diathesis (eg 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 GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
  • Have a platelet count less than 30,000mm3 determined within the 28 days prior to surgery
  • Pre-existing dependence on narcotics or known tolerance to opioids
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Cooper Green Hospital / Jefferson Clinic

Birmingham, Alabama, 35233, United States

Location

Medical Center East / Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Springhill Hospital / Wilmax Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.

Mobile, Alabama, 36652-2144, United States

Location

Jackson Hospital / Drug Research and Analysis Corporation

Montgomery, Alabama, 36106, United States

Location

Baptist Medical Center South / Drug Research and Analysis Corporation

Montgomery, Alabama, 36111, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Valley OB/GYN

Colton, California, 92324, United States

Location

Research Support Personnel LLC

Wichita, Kansas, 67208, United States

Location

Chandler Medical Center; Ken Muse Research

Lexington, Kentucky, 40536, United States

Location

Comprehensive Pain Specialists

Hendersonville, Tennessee, 37075, United States

Location

Health First Medical Group

Fort Worth, Texas, 76135, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Related Publications (1)

  • Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.

    PMID: 19843482DERIVED

MeSH Terms

Conditions

Pain

Interventions

Saline SolutionIbuprofen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Amy Rock, Ph.D.
Organization
Cumberland Pharmaceuticals Inc.
arock@cumberlandpharma.com
615-255-0068

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

June 22, 2016

Results First Posted

September 15, 2011

Record last verified: 2016-05

Locations

US(12)AU(1)