Oral treatment for post-operative pain with dexketoprofen trometamol and tramadol hydrochloride

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 600

Inclusion Criteria

1.Female patients aged 18 to 75 years.
2.Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions, requiring an infraumbilical laparotomy of = 3 cm (either longitudinal or transverse) and hospitalization for at least 3 days after the surgery.
3.Mentally competent, able to understand and give written informed consent prior to study entry. Compliant to undergo all visits and procedures scheduled in the study, including recording of pain assessment on the electronic diary (e-Diary) as required by protocol.
4.ASA (American Society of Anaesthesiologists) Patient Classification Status I, II or III.
5.Patients experiencing pain at rest of at least moderate intensity (PI-VAS = 40 mm) the day after surgery, who are capable of swallowing oral medication and suitable to be randomized and dosed by 10:00 a.m.

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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1.Patients undergoing laparoscopic surgery or supraumbilical laparotomy.
2.Patients who are judged by the Investigator not to be suitable candidates for study treatments and RM based on their medical history, physical examination, concomitant medication (CM) and concurrent systemic diseases.
3.Patients with clinically significant abnormalities of vital signs (VS), safety laboratory tests and 12-lead ECG at screening.
4.Patients with history of allergy or hypersensitivity to the study drugs, RM or to any other NSAIDs, opioids, acetyl salicylic acid, pyrazolones or pyrazolidines.
5.Patients with history of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
6.Patients with history of severe asthma.
7.Patients with severe renal, hepatic or cardiac dysfunction.
8.Patients with coagulation disorders.
9.Patients with history or current epilepsy.
10.Patients with Crohn’s disease or ulcerative colitis.
11.Patients with acute intermittent hepatic porphyria.
12.Patients with congenital G6PD (glucose-6-phosphate dehydrogenase) deficiency.
13.Patients with impaired bone marrow function (e.g. following treatment with cytostatic drugs) or haematopoiesis disorders.
14.Patients using and not suitable for withdrawing analgesics (NSAIDs, opioids and related drugs), other than those specified in the protocol, prior to the start of surgery (5 days before surgery in case of COX-2 inhibitors) up to completion of last pain assessment (i.e. 8 hours after last intake of study medication).
NOTE: paracetamol 500mg as antipyretic agent might be used only when strictly necessary; however, it is not allowed within the 6 hours prior to randomization and during the single-dose phase, until completion of the 8 hours post-dose assessment.
15.Patients under chronic opioid treatment (major opioids and tramadol).
16.Patients using and not suitable for withdrawing the following prohibited medication, within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery up to 24 hours after the last intake of study medication:
-Anticoagulants (except standard peri-operative use for thrombo-embolic prophylaxis), thrombolytic and antiplatelet agents (except = 325 mg aspirin for cardiovascular prophylaxis);
-Corticosteroids (with the exception of inhalers or topical agents);
-Monoamine oxidase (MAO) inhibitors (a minimum of 14 days must elapse prior to the start of surgery);
-Antiepileptics;
-Antipsychotics;
-Serotonin reuptake inhibitors and tricyclic antidepressants;
-Lithium;
-Metotrexate;
-Sulphonamides;
17.Patients receiving concomitant treatment with other investigational drugs or who have participated in other clinical trial within 4 weeks before entering the study.
18.Patients with history of drug or alcohol abuse. For the purpose of the study, alcohol abuse is defined as regularly intake of more than 4 units of alcohol per day (1 unit corresponds approximately to 125 ml wine, 200 ml beer, 25 ml spirit).
19.Patients with a history of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
20.Breastfeeding women.
21.Patients experiencing any surgical complication that, in the opinion of the Investigator, advises against their inclusion in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the analgesic efficacy of oral DKP.TRIS and TRAM.HCl fixed combination on moderate to severe pain after total/subtotal abdominal hysterectomy.;Secondary Objective: To assess the safety and tolerability of the treatment after single and 3-day repeated doses.;Primary end point(s): Mean SPID at rest (Sum of Pain Intensity Difference; calculated as the weighted sum of the PID-VAS values), over 8 hours after the first dose (SPID8).<br>The primary efficacy variable will be used for the assessment of the co-primary efficacy endpoint to test the superiority of DKP.TRIS + TRAM.HCl versus DKP.TRIS and versus TRAM.HCl administered as single agents, in the single-dose phase.<br>;Timepoint(s) of evaluation of this end point: Over 8 hours after the first dose

Secondary Outcome Measures

Name	Time	Method

Oral treatment for post-operative pain with dexketoprofen trometamol and tramadol hydrochloride

Recruitment & Eligibility

Study & Design

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