Clinical trial NCT02254525: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Biomendi S.A.U.
Sponsor class: INDUSTRY
Collaborators: name: Pivotal S.L.
First posted: 2014-10-02
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo
timeFrame: First 24 hours post- surgery
Secondary outcomes:
measure: Secondary efficacy endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary efficacy endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary efficacy endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary efficacy endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary efficacy endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary tolerability and safety endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary tolerability and safety endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary tolerability and safety endpoints
timeFrame: From 0 hours to 72 hours post- surgery
measure: Secondary tolerability and safety endpoints
timeFrame: From 0 hours to 72 hours post- surgery
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Hospital de Móstoles
state: Madrid
city: Vigo
country: Spain
facility: Hospital Xeral Cíes de Vigo
state: Pontevedra
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital de Montepríncipe
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Concepción Pérez, MD
role: STUDY_CHAIR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Francisco Abad, MD
role: STUDY_CHAIR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Dolores Ochoa, MD
role: STUDY_CHAIR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Antonio Planas, MD
role: STUDY_CHAIR
References: