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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02254525 |
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Date of registration:
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25/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain
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Scientific title:
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A Multicenter, Randomized, Double-blind, and Parallel Groups, Placebo-controlled Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain. |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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231 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT02254525 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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Contacts
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Name:
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Francisco Abad, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital La Princesa |
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Name:
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Antonio Planas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital La Princesa |
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Name:
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Concepción Pérez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital La Princesa |
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Name:
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Dolores Ochoa, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital La Princesa |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Men or women between 18 and 80 years old.
2. Being scheduled for elective single surgical site orthopaedic surgery (hip or knee
joint replacement, corsed ligaments, column or shoulder surgery), or abdominal
surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia)
3. Being scheduled for general anaesthesia or regional anesthesia without regional
analgesia after surgery.
4. Having anticipated need for postoperative narcotic analgesia administered by patient
controlled analgesia (PCA).
5. Expected to stay at the hospital for at least 24 h.
6. Providing written informed consent for participating in this study.
Exclusion Criteria:
1. Use of NSAID within 12 hours prior to the first planned dose.
2. Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or
aspirin.
3. Anaemia (haemoglobin <10 g/dl) and/or history or evidence of asthma or heart failure.
4. History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or
aspirin related products, NSAID or COX-2 inhibitors.
5. Pregnant or nursing.
6. Weight less than 40 kg.
7. History of severe head trauma that required hospitalization, intracranial surgery or
stroke within the previous 30 days, or any history of intracerebral arteriovenous
malformation, cerebral aneurism or CNS mass lesion.
8. History of congenital bleeding diathesis or any active clinically significant
bleeding or underlying platelet dysfunction.
9. Gastrointestinal bleeding that required medical intervention.
10. Platelet count less than 80.000 determined within the 28 days prior to surgery.
11. Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
12. Severe renal failure (calculated creatinine clearance < 60 ml/min).
13. Liver failure, ALAT or ASAT >3 times upper limit of normality, or bilirubin >2 g/dl.
14. Diagnosed of Bowel Inflammatory Disease.
15. Not able to understand the requirements of the study, or to abide by the study
restrictions or to return for the required assessments.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: Intravenous ibuprofen
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Drug: Saline solution
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Primary Outcome(s)
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Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo
[Time Frame: First 24 hours post- surgery]
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Secondary Outcome(s)
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Secondary efficacy endpoints
[Time Frame: From 0 hours to 72 hours post- surgery]
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Secondary tolerability and safety endpoints
[Time Frame: From 0 hours to 72 hours post- surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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