Double-blind, randomised, placebo and active controlled, parallel group study to evaluate the analgesic effect of a single oral administration of four different combination doses of DKP.TRIS with TRAM.HCl in comparison with the single agents, on moderate to severe pain following impacted third mandibular molar tooth extraction - ND
- Conditions
- Moderate to severe pain following impacted third mandibular molar tooth extraction.MedDRA version: 9.1Level: LLTClassification code 10044017
- Registration Number
- EUCTR2010-022798-32-IT
- Lead Sponsor
- MENARINI RICERCHE S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1. Male or female patients aged 18 to 70 years. 2. BMI between 18 kg/m2 and 30 kg/m2. 3. Females participating in the study must be either: Of non-childbearing potential, i.e. surgically sterilised or postmenopausal with amenorrhea for at least 2 years prior the study. If indicated, this should be confirmed by follicle-stimulating hormone and estradiol levels (according to local laboratory range). ? Willing to use a highly effective contraceptive method (failure rate < 1% per year) during the entire study period. Appropriate forms of contraception are defined as: i) abstinence- the lifestyle of the female should be such that there is complete abstinence from intercourse from at least the commencement of their last menstrual period prior to dosing with study treatment and continue to the first menstrual period after treatment or 15 days after the last dose of medication whichever is the longest. ii) established use of oral, injected, or implanted hormonal methods of contraception from at least the commencement of their last menstrual period prior to dosing with study treatment and continue to the first menstrual period after treatment. iii) documented placement of an intrauterine device (IUD). iv) male partner sterilisation (vasectomy) prior to the female patient`s entry into the study and is the sole partner for the female patients. 4. Females of childbearing potential must have a negative pregnancy test at Screening. 5. Scheduled for outpatient surgical extraction -under local anaesthesia- of third mandibular molar teeth, with at least one of which is fully or partially impacted in the mandible requiring bone manipulation (e.g. grade ? 5 of Pell-Gregory and Winter scale). 6. Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study and record information required by protocol. 7. Medical history and physical examination normal or without clinically relevant abnormalities on the investigator’s judgement. After surgery, patients meeting the following criteria will be eligible to be randomised into the study: 8. No clinically relevant abnormalities in vital signs, laboratory findings and 12-lead ECG, as per investigator’s judgement. 9. No intake of analgesics (including prescription and over the counter drugs) within 24h prior to the surgery. 10. No intake of prohibited medication (please refer to exclusion criterion # 10). 11. Females of childbearing potential must have a negative pregnancy test before randomisation. 12. Patients with no complication during the surgery, with overall duration of surgery not longer than 1 hour and not requiring re-anaesthesia. 13. Patients experiencing pain of moderate or higher intensity in the first four hours after the end of surgery (VAS score ? 40 mm and VRS score ? 2). 14. Patients agreeing not to take analgesics other than protocol defined rescue medication during the treatment period (up to 24 hours post-dosing).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients with history of allergy or hypersensitivity to the study drugs/rescue medication or to any other NSAIDs, opioids or acetyl salicylic acid. 2. Patients with history of asthma, bronchospasm, acute rhinitis, nasal polyps, uricaria or angioneurotic oedema. 3. Patients with history of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal bleeding or other active bleedings. 4. Patients with moderate to severe renal, hepatic or cardiac dysfunction. 5. Patients with coagulation disorders. 6. Patients with uncontrolled epilepsy. 7. Patients with Crohn’s disease or ulcerative colitis. 8. Patients with history of drug or alcohol abuse. For the purpose of the study, alcohol abuse is defined as follows for males and females, respectively: - an average weekly intake of >21 and >14 units - or an average daily intake of >3 and >2 units One unit corresponds to approx 125 ml wine, 200 ml beer, 25 ml spirit. 9. Patients who are judged by the investigator not to be suitable candidates for study treatment and rescue medication based on medical history, concomitant medication and concurrent systemic disease as described in the product labelling (i.e. warnings, precaution, contraindication and adverse events) of dexketoprofen, tramadol, ibuprofen and paracetamol. 10. Patients who are unable to refrain from alcohol, psychoactive drugs and sedatives (e.g. benzodiazepines) and other prohibited medication as listed below within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery and for 24 hours post-dosing. For analgesic use ONLY, a minimum of 24 hours must elapse prior to the start of surgery. For MAO inhibitors, a minimum of 14 days must elapse prior to the start of surgery. Prohibited medication includes the following: o Analgesic drugs (other NSAIDs and opioids). o Anticoagulants, thrombolytic and antiplatelet agents. o Corticosteroids. o MAO inhibitors. o Antiepileptic drugs. o Antipsychotics. o Serotonin reuptake inhibitors and tricyclic antidepressants. o Lithium. o Metotrexate. o Sulphonamides. 11. Patients using and not suitable for withdrawing other prescription or non prescription drugs which are expected to interfere with the study treatment and procedures or compromise patient safety as described in the product labelling of study treatments/rescue medication, within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery and for 24 hours post-dosing. 12. Patients receiving concomitant treatment with other investigational drugs or who have participated in other clinical trial within 4 weeks before the study enrolment. 13. Pregnant or breastfeeding women. A pregnancy test will be performed to all women of childbearing potential at the Screening and Randomisation Visits and a negative result must be obtained to enroll the patient into the study. 14. Patients who are not able to understand the study nature for any reason (cultural level, language comprehension…) or that the investigator suspects that they are not going to collaborate with the study procedures (e.g. patients with excessive anxiety related to previous negative dental experiences). 15. 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 results of the study (e.g. patients with acute pain of any other origin or localization at the time of surgery).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method