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

NCT02254525 | Terminated Phase 3

• 1 other identifier: BIBEC02
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 13

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo

  The primary efficacy endpoint will be the reduction in total morphine use in the first 24 hours post- surgery as compared to placebo.

  First 24 hours post- surgery

Secondary Outcomes (9)

• Secondary efficacy endpoints

  From 0 hours to 72 hours post- surgery

• Secondary efficacy endpoints

  From 0 hours to 72 hours post- surgery

• Secondary efficacy endpoints

  From 0 hours to 72 hours post- surgery

• Secondary efficacy endpoints

  From 0 hours to 72 hours post- surgery

• Secondary efficacy endpoints

  From 0 hours to 72 hours post- surgery

Study Arms (2)

800 mg intravenous ibuprofen

EXPERIMENTAL

Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours, infused over 15 minutes.

Drug: Intravenous ibuprofen

200 ml of saline solution

PLACEBO COMPARATOR

Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min.

Drug: Saline solution

Interventions

Intravenous ibuprofen DRUG

Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose. All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery.

Also known as: IV ibuprofen

800 mg intravenous ibuprofen

Saline solution DRUG

Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose. All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery.

Also known as: Placebo

200 ml of saline solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women between 18 and 80 years old.
• 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)
• Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.
• Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
• Expected to stay at the hospital for at least 24 h.
• Providing written informed consent for participating in this study.

You may not qualify if:

• Use of NSAID within 12 hours prior to the first planned dose.
• Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
• Anaemia (haemoglobin \<10 g/dl) and/or history or evidence of asthma or heart failure.
• History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
• Pregnant or nursing.
• Weight less than 40 kg.
• 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.
• History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
• Gastrointestinal bleeding that required medical intervention.
• Platelet count less than 80.000 determined within the 28 days prior to surgery.
• Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
• Severe renal failure (calculated creatinine clearance \< 60 ml/min).
• Liver failure, ALAT or ASAT \>3 times upper limit of normality, or bilirubin \>2 g/dl.
• Diagnosed of Bowel Inflammatory Disease.
• Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.

Sponsors & Collaborators

• Biomendi S.A.U.: lead
• Pivotal S.L.: collaborator

Study Sites (13)

Complejo Hospitalario Universitario de A Coruña

A Coruña, La Coruña, 15001, Spain

Location

Hospital Arnau de Vilanova de Lleida

Lleida, Lleida, 25198, Spain

Location

Hospital La Princesa

Madrid, Madrid, 28006, Spain

Location

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital de Montepríncipe

Madrid, Madrid, 28660, Spain

Location

Hospital de Móstoles

Móstoles, Madrid, 28935, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Hospital Xeral Cíes de Vigo

Vigo, Pontevedra, 15781, Spain

Location

Hospital Virgen de la Salud

Toledo, Toledo, 45005, Spain

Location

Hospital La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Clínico de Valladolid

Valladolid, Valladolid, 47005, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Concepción Pérez, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  STUDY CHAIR

• Francisco Abad, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  STUDY CHAIR

• Dolores Ochoa, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  STUDY CHAIR

• Antonio Planas, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 2, 2014
• Study Start: May 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-09

Locations

ES (13)