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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

NCT02254525 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2014-10-02

No results posted yet for this study

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

Interventions

DRUG

Intravenous ibuprofen

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.

DRUG

Saline solution

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.

Sponsors & Collaborators

  • Pivotal S.L.

    collaborator INDUSTRY

  • Biomendi S.A.U.

    lead INDUSTRY

Principal Investigators

  • Concepción Pérez, MD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Francisco Abad, MD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Dolores Ochoa, MD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Antonio Planas, MD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02254525 on ClinicalTrials.gov