ACTRN12611000450910
Completed
Phase 2
Maxi-Analgesic Dose Response Study: A double-blind, placebo-controlled, randomized, parallel group comparison of the effects of diferent paracetamol + ibuprofen combination doses and placebo in participants with pain from removal of 2-4 third molars.
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AFT Pharmaceuticals Ltd.
- Enrollment
- 159
Overview
Brief Summary
All the doses (full dose, half dose and quarter dose) of this fixed dose combination (paracetamol 1000mg + ibuprofen 300mg) provide safe and superior pain relief to placebo in adults for post-operative dental surgery pain relief.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 16 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •1\)Provide written informed consent before initiation of any study\-related procedures (including the willingness to stay at the hospital up to 6 hours after the surgery).
- •2\)Males and females aged at least 16 years and not more than 60 years old on the day of consent.
- •3\)Undergoing oral surgery for the extraction of 2\-4 impacted 3rd molar teeth, one of which must be mandibular and require bone removal. The molars removed, are either bilateral or ipsilateral.
- •4\)A resting VAS pain intensity score at baseline (within 6 hours following completion of surgery) of greater than or equal to 50mm on a 100mm VAS scale with 0 ( no pain) and 100 (worst pain imaginable).
Exclusion Criteria
- •Study contra\-indications
- •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 anesthetics from midnight the night prior to surgery, except for lidocaine with epinephrine, nitrous oxide, diazepam (Valium \[Registered Trademark]), methohexitol (Brevital\[Registered Trademark]).
- •3\)Hypersensitivity to opioids
- •4\)Known to be pregnant or possibly pregnant.
- •5\)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.
- •6\)Women of childbearing potential who are unwilling to undergo a urine pregnancy test
- •7\)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.
- •8\)In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
- •9\)Currently or in the last 30 days, has been in a clinical trial involving another study drug.
Investigators
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