Postoperative acute pain. MedDRA version: 14.1 Level: LLT Classification code 10027289 Term: Meniscectomy (knee) System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: SPIDIFEN*OS GRAT 30BUST 600MG
Pharmaceutical Form: Effervescent granules
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Tr
Sponsors
ZAMBON S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male or female patients aged = 18 and = 65 years; 2)Patients undergoing to mini invasive orthopaedic surgery (meniscectomy) in loco-regional anaesthesia; 3)Patients having a pain intensity of 50 or more on a 0-100 VAS in the post-surgical period; 4)American Society of Anaesthesiologists (ASA) physical status I and II for the whole study duration; 5)Signed informed consent; 6)Willing and able to comply with study procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1)Ascertained or presumptive hypersensitivity to the active compound and/or any of the formulation excipients; 2)History of anaphylaxis to drugs or allergic reactions; in particular, history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria, angioedema) to non-steroidal anti-inflammatory drugs (NSAIDs); 3)Obstructive respiratory syndromes (asthma or COPD), nasal polyposis or any other chronic respiratory disease; 4)History of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment); 5)Severe neurological diseases, including dementia, anxiety, mental retardation, multiple sclerosis, Parkinson’s disease, uncontrolled epilepsy; 6)Transient ischemic attack or cerebrovascular accident within the last three months before the screening visit; 7)Myocardial infarction, unstable angina, arrhythmias, cardiac failure or other chronic cardiac diseases; 8)Significant kidney (serum creatinine = 2.0 mg/dL or 180 µmol/L) or liver disease (serum transaminases = 3 x upper limit of normal); 9)History of gastrointestinal diseases, active peptic ulcer, gastrointestinal bleeding in the preceding 6 months before the screening visit; 10)Inflammatory Bowel Diseases (IBD); 11)Phenylchetonuria; 12)Autoimmune diseases; 13)Blood coagulation disorders or anticoagulants use within the last month before the screening visit; 14)Symptomatic osteoarthritis requiring medical therapy or inflammatory arthritis; 15)Arthroscopic knee surgery within the last 6 months before the screening visit; 16)Body mass index (BMI) = 35 kg/m2; 17)Use of paracetamol within 24 hours before the randomization visit; 18)Use of muscle relaxants 24 hours before the randomization visit; 19)Use of systemic and topical preparations of NSAIDs within 48 hours before the randomization visit; 20)Use of opioids within 7 days before the randomization visit; 21)Use of systemic and topical preparations of corticosteroids within 14 days before the randomization visit; 22)Any clinical significant abnormal laboratory values as judged by the Investigator; 23)Pregnant or lactating women or women of childbearing age not using a reliable method of contraception (hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months prior to the screening visit; a non-hormonal intrauterine device [IUD] with spermicide), or in postmenopausal status for less than 2 years; 24)Intake of investigational drug within the last 30 days before the screening visit; 25)History of alcohol or drug abuse; 26)Donation of blood in the previous 3 months before the screening visit; 27)Inadequate comprehension of study risks and requirements, or uncooperative patient; 28)Any other clinical condition or disease or history of significant diseases which, in the opinion of the Investigator, makes the subject inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the speed of action and global clinical efficacy of IBA in comparison with IBU in patients with postoperative acute pain.;Secondary Objective: none;Primary end point(s): To assess the clinical efficacy of the two investigational medicinal products (IMPs), IBA and IBU, on the time to onset of pain relief (when the patient begins to feel any pain relieving effect from the drug) in the first 60 minutes after study medication intake. The effect of IBA or IBU will be assessed, for this first 60 minute observation period, in absence of intake of any rescue medication, using a stopwatch clock.;Timepoint(s) of evaluation of this end point: 60 minutes after study medication intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The evaluation of Total Pain relief (TOTPAR) by the measurement of the area under the curve (AUC) of pain intensity values, assessed by the patients, using a Visual Analogue Scale (VAS) during the first 60 minutes after study medication intake; •The proportion of patients with at least 50% pain relief; •The pain relief (PR) effect, at each observation point, using a Pain Relief Rating (PRR) score of five points; •The time to achievement the “meaningful pain relief” (when the patient feels his pain relief is meaningful to him) using a stopwatch clock; •The time to the first intake of rescue medication; •The rate of remedication (proportion of patients who require rescue medication); •The Clinical Global Impression (CGI) of the patient at the end of the study (360th minute), using a 7 point scale; •The Pain Intensity Difference at each observation point (PID) (the pain intensity differences from baseline); •The Sum of Pain Intensity Difference (SPID). •Frequency of Adverse Events in the two treatment groups;Timepoint(s) of evaluation of this end point: 60 minutes after study medication intake. | — |
Countries
Italy
Contacts
Public ContactSponsor Contact Person
Zambon S.p.A.
Outcome results
None listed