None listed
Conditions
Brief summary
A Phase 3 study in dental pain has demonstrated efficacy for the fixed-dose combination compared with the individual components(Merry et al. 2010). However an additional model of acute pain is required to demonstrate consistent efficacy in acute pain as per EMEA guidelines required (EMEA/CPMP/EWP/612/00 21 November, 2002). The fixed dose combination has already been approved in New Zealand and is on the market for OTC use. Periodic Safety Update data from the NZ market and also the open –label phase of the Phase II Osteoarthritis study 12 month continuation phase data are available.
Interventions
A combination of Paracetamol 500mg + Ibuprofen 150mg per tablet, 2 tablets orally every 6 hours for 24 hours.
Sponsors
AFT Pharmaceuticals Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1)Provide written informed consent before initiation of any study-related procedures (including the willingness of staying at the hospital up to 6 hours after the surgery). 2)Males and females aged at least 16 years and not more than 80 years old on the day of consent. 3)Undergoing arthroscopy for removal of meniscus around the knee under standardized general anaesthesia (see section 5.7). 4)A resting VAS pain intensity score at baseline (within 6 hours following completion of surgery) of = 40mm on a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable.
Exclusion criteria
1)Has taken any NSAID or paracetamol within 12 hours prior to the start of surgery other than aspirin less than or equal to 150mg/day. 2)Subjects who have received any anaesthetics within 24 hours prior to surgery 3)Hypersensitivity to oxycodone 4)Administration of any intra-articular drug during the surgery including morphine, bupivacain, lidocaine or tramadol etc. 5)Known hypersensitivity to oxycodone 6)Known history of drug or alcohol abuse 7)Known to be pregnant or possibly pregnant. 8)Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence (should the subject become sexually active, she must agree to use a double-barrier method of contraception). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g., bilateral tubal ligation, bilateral oophorectomy. 9)Women of childbearing potential who are unwilling to undergo a urine pregnancy test 10)Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the investigator, makes the subject unsuitable from an efficacy or safety perspective. 11)In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements. 12)Currently or in the last 30 days, has been in a clinical trial involving another study drug. 13)Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids or topical steroids with the approval of the investigator), cyclosporin, tacrolimus or methotrexate, or any other medication felt by the investigator to interfere with safety or efficacy evaluations. 14)Participant weight < 50kg or > 120 Kg. 15)Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant’s best interests to participate in this study. NSAID and/or paracetamol contra-indications 16)Hypersensitivity to aspirin or other NSAID. 17)Hypersensitivity to paracetamol. 18)Severe known haemopoetic, renal or hepatic disease, or immunosuppressed. 19)History of gastric ulceration and bleeding or other GI disorders that, in the opinion of the investigator make the subject unsuitable (e.g., frequent treatment of GERD, inflammatory bowel disease, etc.). 20)History of severe asthma defined as asthma requiring frequent or ongoing treatment to control symptoms. Exercise-induced asthma or mild asthma not requiring ongoing treatment may not be exclusionary at the discretion of the investigator.
Outcome results
None listed