Trial to evaluate the analgesic efficacy and safety of ibuprofen arginine/tramadol compared with ibuprofen alone and placebo, in patients with moderate to severe pain after non-oncological abdominal hysterectomy.

• Conditions: Evaluation of the analgesic efficacy in patients with moderate to severe pain after non-oncological abdominal surgery.; MedDRA version: 17.1Level: PTClassification code 10021151Term: HysterectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-004081-21-HU
• Lead Sponsor: aboratorios Farmalíder S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-09
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 444

Inclusion Criteria

Main inclusion criteria:
1.Female, from 18 to 75 years of age.
2.Scheduled for total or partial abdominal hysterectomy due to a benign process, requiring hospitalisation for at least 48 hours after the surgery.
3.Mentally competent, able to understand and grant their written informed consent before entering the study. Willing to undergo the scheduled study procedures, including entering their pain assessment value in the patient diary as established in the protocol.
4.Class I, II or III of the ASA (American Society of Anesthesiologists) patient classification system.
5.Patient with at least moderate (VAS = 4 cm) pain at rest the day after surgery, able to swallow oral medication, for whom randomisation and dose allocation is possible within 4 hours of withdrawing intravenous analgesia.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 144

Exclusion Criteria

1.Patient considered by the investigator to be unsuitable for the study treatment and/or rescue medication (RM) based on her medical history, physical examination, concomitant medication (CM) and concomitant systemic diseases.
2.Complications during the surgery or the period prior to randomisation, in the investigator's opinion.
3.Local or systemic acute infection at the time of surgery that could confuse the post-surgical assessment.
4.Patients with clinical signs of gastritis, history of peptic ulcer, GI haemorrhage or diseases that, in the investigator's opinion, could be negatively affected by the administration of an NSAID.
5.Clinical signs or history of clotting disorders that could be negatively affected by the administration of an NSAID.
6.Severe liver, kidney or heart failure.
7.History of seizures or drug or alcohol abuse in the six months before the study.
8.Patients in chronic treatment with NSAIDs and/or opioids (major and tramadol).
9.Patients who use and cannot suspend topical or systemic analgesics other than those specified in the protocol, from before the start of the surgery (5 days before in the case of COX-2 inhibitors) until the end of the last pain assessment.
10.Patients on treatment with drugs that reduce the seizure threshold (MAO inhibitors, SSRIs, methylphenidate, etc.).
11.Hypersensitivity or allergy to the study drugs or RM.
12.Patients taking any concomitant medication, the use of which could be susceptible to interacting with ibuprofen and/or tramadol, or could affect safety.
13.Breastfeeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the analgesic efficacy of the combination at fixed doses of ibuprofen arginine and tramadol hydrochloride, in oral administration, versus the components separately and placebo, in patients with moderate to severe pain after abdominal surgery.;Secondary Objective: The secondary objective is to evaluate single-dose efficacy and the safety and tolerability of all the products.;Primary end point(s): Efficacy: The primary efficacy endpoint will be pain intensity as measured by VAS. The main criterion of the analysis will be pain intensity 24 hours after the start of the treatment. <br><br>Safety: The safety evaluations will include a general physical examination, vital signs and rate of adverse events. <br>;Timepoint(s) of evaluation of this end point: 24 h.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary: The secondary endpoints will be: <br>•Pain intensity differences (PID) and reduction of pain (SPID - Score Pain Intensity Differences) at 6 (SPID 0-6h), 24 (SPID 0-24h) and 48 (SPID 0-48h) hours.<br>•Rescue medication: rate of use of rescue medication, time to use of rescue medication.<br>•Pain relief at each time point. Total pain relief at 6, 24 and 48 hours (TOTPAR 0-6h, 0-24h and 0-48h) and time to significant relief. <br>•Rate of patients who respond to the treatment. ;Timepoint(s) of evaluation of this end point: 6, 24, 48 h.