NCT00606489

Brief Summary

The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
2 countries

5 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

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 11, 2011

Completed
Last Updated

August 11, 2011

Status Verified

July 1, 2011

Enrollment Period

1.5 years

First QC Date

January 22, 2008

Results QC Date

April 4, 2011

Last Update Submit

July 18, 2011

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

  • Temperature

    Area under the curve temperature from baseline to hour 24 following initiation of treatment.

    0 to 24 hours

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

2

EXPERIMENTAL
Drug: Caldolor

Interventions

CaldolorDRUG

800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours

2
PlaceboDRUG

Placebo

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with second and/or third degree thermal burns covering more than 10 percent total body surface area (including face) with anticipated hospital stay greater than 72 hours.
  • Adequate intravenous access
  • Have fever, documented by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit)

You may not qualify if:

  • Patients with electric burns
  • Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever reducing medications within 4 hours prior to dosing
  • Patients taking warfarin or lithium
  • Active, clinically significant asthma
  • History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), 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 aneurism or central nervous system mass lesion
  • Have a history of congenital bleeding diathesis (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 gastrointestional bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
  • Have a platelet count less than 20,000 mm\^3
  • Be on dialysis
  • Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is acceptable)
  • 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 (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)
  • Refusal to provide written authorization for use and disclosure of protected health information (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)
  • Have received another investigational drug within the past 30 days
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Orlando Regional Medical Center

Orlando, Florida, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Naik's Hospital

Baroda, Kothi, 390001, India

Location

Lokmanya Tilak Municipal Medical College

Mumbai, Sion, 400022, India

Location

Surya Hospitals Pvt. Ltd

Pune, 411 011, India

Location

MeSH Terms

Conditions

Burns

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Amy Rock, Doctor of Philosophy (Ph.D.)
Organization
Cumberland Pharmaceuticals
arock@cumberlandpharma.com
6152550068

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

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 4, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 11, 2011

Results First Posted

August 11, 2011

Record last verified: 2011-07

Locations

US(2)IN(3)