A study comparing the effects of different paracetamol and ibuprofen combination doses and placebo

Phase 2

Completed

• Conditions: Post-operative pain from removal of 2-4 third molars; Anaesthesiology - Anaesthetics; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12611000450910
• Lead Sponsor: AFT Pharmaceuticals Ltd.

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-03
• Study Completion: 2012-10-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 159

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.
10)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.
11)Participant weight < 50kg.
12)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
13)Hypersensitivity to aspirin or other NSAID.
14)Hypersensitivity to paracetamol.
15)Severe known haemopoetic, renal or hepatic disease, or immunosuppressed.
16)History of gastric ulceration 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.).
17)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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified