PainPhase 3NCT00225732
Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
A Phase 3 study testing Intravenous ibuprofen in people with Pain, run by Cumberland Pharmaceuticals at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Intravenous ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2005to Jan 2008
- Phase
- Phase 3
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
- 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
- Refusal to provide written authorization for use and disclosure of protected health information
- Be on dialysis, have oliguria or calculated creatinine clearance of less than 60 mL/min (calculated using the Cockcroft and Gault formula) determined within the 28 days prior to surgery
- Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge
- Operative procedure includes organ transplant
- Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)
- Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)
- Have received another investigational drug within the past 30 days
- Be otherwise unsuitable for the study in the opinion of the investigator
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Cooper Green Hospital / Jefferson Clinic
Birmingham, Alabama, 35233
Medical Center East / Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Valley OB/GYN
Colton, California, 92324
Health First Medical Group
Fort Worth, Texas, 76135
Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075
Chandler Medical Center; Ken Muse Research
Lexington, Kentucky, 40536
Springhill Hospital / Wilmax Clinical Research, Inc.
Mobile, Alabama, 36608
Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.
Mobile, Alabama, 36652-2144
Jackson Hospital / Drug Research and Analysis Corporation
Montgomery, Alabama, 36106
Baptist Medical Center South / Drug Research and Analysis Corporation
Montgomery, Alabama, 36111
Arizona Research Center
Phoenix, Arizona, 85023
Research Support Personnel LLC
Wichita, Kansas, 67208
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients
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
- Conditions
- Pain
- Being tested
- Normal saline as placebo comparator, 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.
Normal saline as placebo comparatorOther
Also called NS
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)
Intravenous ibuprofenDrug
Also called Caldolor
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)
| Study group | Role | What they receive |
|---|---|---|
| intravenous ibuprofen | Active comparator | Not described Receives: Drug: Intravenous ibuprofen |
| normal saline | Placebo comparator | Not described Receives: Other: Normal saline as placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225732
- Sponsor's protocol ID
- CPI-CL-008
- Status last verified
- May 2016
- First submitted
- 22 Sep 2005
- Last updated
- 22 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19843482
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients
- ClinicalTrials.gov ID
- NCT00225732
- Acronym / sponsor ID
- CPI-CL-008
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Posted 15 Sep 2011
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous ibuprofen | Active comparator | Drug: Intravenous ibuprofen |
| normal saline | Placebo comparator | Other: Normal saline as placebo comparator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (24 listed)
- 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
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 |
|---|---|---|
| Normal saline as placebo comparatorAlso: NS250 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) | Other | normal saline |
| Intravenous ibuprofenAlso: Caldolor800 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) | Drug | intravenous ibuprofen |
Primary outcome
Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery
Time frame: 24 Hours
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19843482Southworth 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous ibuprofen in people with Pain, run by Cumberland Pharmaceuticals at 13 sites in 2 countries.
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 3 inclusion and 24 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 22 Jun 2016. 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, Australia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Sep 2011). 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?
Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery (time frame: 24 Hours). 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 NCT00225732, 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 22 Jun 2016.