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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1.Male or female patients aged 18 to 80 years. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly contraceptive method.
2.Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to osteoarthritis (excluding osteoarthritis secondary to systemic/ metabolic diseases, trauma and infections) and requiring hospitalization for at least 5 days after the surgery.
3.ASA (American Society of Anaesthesiologists) Patient Classification Status I, II or III.
4.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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1.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.
2.Patients with clinically significant abnormalities of vital signs (VS), safety laboratory tests and 12-lead ECG at screening.
3.Patients with history of allergy or hypersensitivity to the study drugs, RM or to any other NSAIDs, opioids, acetyl salicylic acid, pyrazolones or pyrazolidines.
4.Patients with history of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
5.Patients with history of severe asthma.
6.Patients with moderate to severe renal dysfunction, severe hepatic dysfunction or severe cardiac dysfunction.
7.Patients with coagulation disorders.
8.Patients with history or current epilepsy.
9.Patients with Crohn’s disease or ulcerative colitis.
10.Patients with acute intermittent hepatic porphyria.
11.Patients with congenital G6PD (glucose-6-phosphate dehydro-genase) deficiency.
12.Patients with impaired bone marrow function (e.g. following treatment with cytostatic drugs) or haematopoiesis disorders.
13.Patients using and not suitable for withdrawing analgesics, other than those specified in the protocol, from the end of surgery (5 days before surgery in case of COX-2 inhibitors) up to completion of last study assessment (i.e. 8 hours after last intake of study medication).
14.Patients under chronic opioid treatment (major opioids and tramadol).
15.Patients using and not suitable for withdrawing the prohibited medication, within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery and up to 24 hours after the last intake of study medication:
-Anticoagulants, thrombolytic and antiplatelet agents (except standad pri-operative use for thrombo-embolic prophylaxis and = 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;
- Methotrexate;
- Antibacterial sulfonamides
16.Patients receiving concomitant treatment with other investigational drugs or who have participated in other clinical trial within 4 weeks before entering the study.
17.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).
18.Pregnant and breastfeeding women.
19.Patients experiencing any surgical complication that, in the opinion of the Investigator, advises against their inclusion in the study.
20.Patients experiencing any surgical complication that, in the opinion
of the Investigator, advises against their inclusion in the study
21.Patients who are exposed to ondansetron (or other 5-HT-3 receptor
antagonist antiemetics) on the day of randomization. NOTE: 5-HT-3
receptor antagonist antiemetics are prohibited from the day of
randomization up to completion of last study assessment (i.e. 8 hours
after last intake of study medication).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess the safety and tolerability of the treatment after single and 5-day repeated doses.;Main Objective: To evaluate the analgesic efficacy of oral DKP.TRIS and TRAM.HCl fixed combination on moderate to severe pain after elective hip arthroplasty.;Primary end point(s): -Mean SPID at rest (Sum of Pain Intensity Differences, 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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