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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

Information source: Biomendi S.A.U.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Intravenous ibuprofen (Drug); Saline solution (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Biomendi S.A.U.

Official(s) and/or principal investigator(s):
Concepción Pérez, MD, Study Chair, Affiliation: Hospital La Princesa
Francisco Abad, MD, Study Chair, Affiliation: Hospital La Princesa
Dolores Ochoa, MD, Study Chair, Affiliation: Hospital La Princesa
Antonio Planas, MD, Study Chair, Affiliation: Hospital La Princesa

Summary

The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo

Secondary outcome:

Secondary efficacy endpoints

Secondary efficacy endpoints

Secondary efficacy endpoints

Secondary efficacy endpoints

Secondary efficacy endpoints

Secondary tolerability and safety endpoints

Secondary tolerability and safety endpoints

Secondary tolerability and safety endpoints

Secondary tolerability and safety endpoints

Detailed description: This is a phase III, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled. Patients will be randomized to receive either ibuprofen or placebo. Stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. Randomization sequence will be generated in the coordinating centre. Blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling. All patients will receive morphine administered by patient controlled analgesia (PCA) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Complejo Hospitalario Universitario de A Coruña, La Coruña 15001, Spain

Hospital Arnau de Vilanova de Lleida, Lleida 25198, Spain

Fundación Jiménez Díaz, Madrid 28040, Spain

Hospital 12 de Octubre, Madrid 28041, Spain

Hospital de Montepríncipe, Madrid 28660, Spain

Hospital La Princesa, Madrid 28006, Spain

Clínica Universitaria de Navarra, Pamplona 31008, Spain

Hospital Virgen de la Salud, Toledo 45005, Spain

Hospital La Fe, Valencia 46026, Spain

Hospital Clínico de Valladolid, Valladolid 47005, Spain

Hospital de Móstoles, Móstoles, Madrid 28935, Spain

Hospital Xeral Cíes de Vigo, Vigo, Pontevedra 15781, Spain

Hospital de Cruces, Barakaldo, Vizcaya 48903, Spain

Additional Information

Starting date: May 2012
Last updated: October 1, 2014

Page last updated: August 23, 2015

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