PainPhase 3NCT00470600
Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
A Phase 3 study testing Caldolor and Normal Saline in people with Pain, run by Cumberland Pharmaceuticals at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Caldolor and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2007to Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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 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
Show all 23Show fewer
- 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
- Refusal to provide written authorization for use and disclosure of protected health information
- Be on dialysis, have oliguria or creatinine greater than 3.0 milligram/deciliter.
- 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
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Clinical Management Services, Inc.
Arcadia, California, 91007
Southeastern Center for Clinical Trials
Atlanta, Georgia, 30350
Research Concepts, Inc
Houston, Texas, 77054
Research Concepts, Inc.
Houston, Texas, 77401
Teton Research, LLC
Little Rock, Arkansas, 72205
Wilmax Clinical Research Inc.
Mobile, Alabama, 336608
South Africa3 sites
Johannesburg General Hospital
Johannesburg
Krugersdorp Private Hospital
Krugersdorp
Eugene Marais Hospital
Pretoria
About this study
Official title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF IBUPROFEN INJECTION (IVIb) FOR TREATMENT OF PAIN IN POST-OPERATIVE ORTHOPEDIC ADULT PATIENTS
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
- Being tested
- Caldolor, Normal Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaldolorDrug
Also called Ibuprofen
800 milligrams intravenous
Normal SalineOther
Also called NS
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Caldolor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Study hour-6 through hour-28
Secondary outcomes (2)
Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)
Measurement of the patient's self assessment of pain at rest using a 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 and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
Measured: Study hour-6 through hour-28
Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).
Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.
Measured: Study hour-6 to hour-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2008
- Study completionSep 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.
- 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Singla, MD, Principal investigator, Lotus Clinical Research/Methodist Hospital of Southern CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470600
- Sponsor's protocol ID
- CPI-CL-008C
- Status last verified
- Aug 2015
- First submitted
- 7 May 2007
- Last updated
- 21 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. 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 POST-OPERATIVE ORTHOPEDIC ADULT PATIENTS
- ClinicalTrials.gov ID
- NCT00470600
- Acronym / sponsor ID
- CPI-CL-008C
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 May 2007 (estimated)
- Results
- Posted 8 Dec 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 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.
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 |
|---|---|---|
| Normal Saline | Placebo comparator | Other: Normal Saline250 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. |
| Intravenous ibuprofen | Experimental | Drug: Caldolor800 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (23 listed)
- 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
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 |
|---|---|---|
| CaldolorAlso: Ibuprofen800 milligrams intravenous | Drug | Intravenous ibuprofen |
| Normal SalineAlso: NSPlacebo comparator | Other | Normal Saline |
Primary outcome
AUC-VAS With Movement (Post-operative Period, Hour-6-28)
Time frame: Study hour-6 through hour-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).
2 secondary outcomes
Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)
Time frame: Study hour-6 through hour-28
Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).
Time frame: Study hour-6 to hour-28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Neil Singla, MD principal investigator
Lotus Clinical Research/Methodist Hospital of Southern CA
9 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 Caldolor and Normal Saline in people with Pain, run by Cumberland Pharmaceuticals at 9 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 23 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 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, South Africa. 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 8 Dec 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?
AUC-VAS With Movement (Post-operative Period, Hour-6-28) (time frame: Study hour-6 through hour-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2015.