Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients

NCT00470600 | Completed Phase 3 Results DMC

• 1 other identifier: CPI-CL-008C
• Study Type: interventional
• Target: 185
• Locations: 2 countries
• Sites: 9

Brief Summary

The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• AUC-VAS With Movement (Post-operative Period, Hour-6-28)

  Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery \[variable since every surgery has a unique length of time even if it is the same procedure\] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).

  Study hour-6 through hour-28

Secondary Outcomes (2)

• Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)

  Study hour-6 through hour-28

• Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).

  Study hour-6 to hour-28

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.

Other: Normal Saline

Intravenous ibuprofen

EXPERIMENTAL

800 mg of intravenous ibuprofen diluted in 250 milliliters normal saline was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.

Drug: Caldolor

Interventions

Caldolor DRUG

800 milligrams intravenous

Also known as: Ibuprofen

Intravenous ibuprofen

Normal Saline OTHER

Placebo comparator

Also known as: NS

Normal Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective hip or knee replacement, reconstruction or arthroplasty surgery with anticipated need for post-operative intravenous (IV) morphine analgesia with anticipated use of (greater than or equal to (≥) 28 hours.
• Adequate IV access
• Anticipated hospital stay ≥ 28 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 80 years of age
• Use of analgesics, muscle relaxants, NSAIDS and sedatives less than 12 hours prior to clinicaltrial material(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 angiotension converting enzyme(ACE)-inhibitors and furosemide
• Patients with anemia (active, clinically significant anemia) 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 30 kilogram
• 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 (GI) bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
• Have a platelet count less than 30,000 mm\^3 determined within the 28 days prior to surgery
• Pre-existing dependence on narcotics or known tolerance to opioids
• 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 and to return for the required assessments

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (9)

Wilmax Clinical Research Inc.

Mobile, Alabama, 336608, United States

Location

Teton Research, LLC

Little Rock, Arkansas, 72205, United States

Location

Clinical Management Services, Inc.

Arcadia, California, 91007, United States

Location

Southeastern Center for Clinical Trials

Atlanta, Georgia, 30350, United States

Location

Research Concepts, Inc

Houston, Texas, 77054, United States

Location

Research Concepts, Inc.

Houston, Texas, 77401, United States

Location

Johannesburg General Hospital

Johannesburg, South Africa

Location

Krugersdorp Private Hospital

Krugersdorp, South Africa

Location

Eugene Marais Hospital

Pretoria, South Africa

Location

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Amy Rock, Ph.D.
• Organization: Cumberland Pharmaceuticals

arock@cumberlandpharma.com

615-255-0068

Study Officials

• Neil Singla, MD

  Lotus Clinical Research/Methodist Hospital of Southern CA

  PRINCIPAL INVESTIGATOR

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: May 7, 2007
• First Posted: May 8, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 21, 2015
• Results First Posted: December 8, 2011

Record last verified: 2015-08

Locations

US (6); ZA (3)