Dental pain Oral Health Other disorders of teeth and supporting structures
Conditions
Interventions
This was a two part study, the objective of Part 1 was to assess the efficacy and tolerability of a fixed-dose combination tablet containing ibuprofen and acetaminophen as follow:
1. I
Sponsors
Reckitt Benckiser Healthcare (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: Subjects at least 16 years of age were eligible to participate 2. Sex: Both males and females were eligible for entry 3. Primary Diagnosis: At least three impacted third molars (two of which must have been mandibular impacted molars) indicated for removal. Both mandibular impactions must have required bone removal, and there must have been a total score of 9 or greater on the impaction grading scale for the three or four impacted third molar 4. Baseline pain intensity (PI): Subjects must have been experiencing moderate to severe postoperative pain based on the Pain Intensity Categorical Rating Scale and have a PI Visual Analogue Scale (VAS) score of 50mm or greater on the 100mm within 6 hours of completion of surgery, but more than 3 hours after the last administration of fentanyl 5. Subjects who gave written informed consent. Subjects who were 16 or 17 years of age also required their parents or legal guardian to provide written informed consent in addition to their written assent
Exclusion criteria
Exclusion criteria: 1. Those who had participated in a clinical trial in the previous 12 weeks. Twelve weeks calculated from the time of last dosing in the prior trial to time of anticipated first dosing in this trial. 2. A current history of significant disease deemed by the Investigator to render the subject unsuitable for inclusion 3. An ongoing painful condition other than that associated with the current third molar surgery 4. Any ongoing condition that may have interfered with the absorption, distribution, metabolism or excretion of the study medication 5. A history of allergy or intolerance (including angioedema, urticaria, bronchospasm and rhinitis) related to the treatment with ibuprofen, acetaminophen, aspirin, other NSAIDs or any other medication used in this study, including anaesthetics and antibiotics that may have been required on the day of the surgery (Day 1) or the formulation constituents of the study medications 6. A history of frequent peptic ulcers, duodenal ulcers or gastrointestinal (GI) bleeding 7. A history of frequent dyspepsia, heartburn or indigestion 8. A history of migraine headaches within the past year 9. A history of psychotic illness, attempted suicide or neurosis 10. Those unable to refrain from smoking during their stay in the research centre 11. A positive history of drug or alcohol abuse within the past six months 12. Those who were taking any concomitant medication that might have confounded assessments of pain relief (PAR), such as: psychotropic drugs, antidepressants, sedative-hypnotics (other than those permitted for conscious sedation), or other analgesics taken within five times of their elimination half lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs) were permitted if the subject had been on a stable dose for at least four weeks prior to visit 1 (screening). 13. Those previously randomised into this study 14. Subjects who had received ant analgesic, anti-inflammatory drug, sedative-hypnotic, or caffeine containing food or drink from midnight the night prior to surgery and during the entire 80 hours post-dose assessment period, except for the study medication, perioperative sedative, antibiotics or permitted anaesthetics. The following anaesthetics were permitted lidocaine with epinephrine, nitrous oxide, diazepam (Valium), methohexitol (Brevital) and fentanyl. The following antibiotics were permitted: penicillin, macrolide antibiotics, clindamycin and topical tetracycline gelfoam. 15. Those who were unable, in the opinion of the investigator, to comply fully with the study requirements. 16. Those with abnormal liver function tests at screening 17. A history of epileptic seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in Part 1 was SPRID0-8h and in Part 2 was the number of complete 24-hours periods (as 0, 1, 2, 3) with no more than one dose of rescue medication and with the subjects overall assessment always rated as at least good (i.e., 3, 4, 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The key secondary endpoint for Part 1: 1.2. The first recorded post-baseline assessment of the subjects overall assessment of the study medication as a treatment for pain on a 5-point Overall Assessment Categorical Rating Scale. This variable was assessed at 8 hours or just prior to administration of rescue medication if sooner 1.3. Duration of pain half gone. This was calculated in a analogous was to TOTPAR but using zero (pain not half gone) and one (pain half gone) 1.4. Time to meaningful PAR using the two-stopwatch technique 1.5. Duration of the effect measured as time to first administrate of rescue medication. Rescues medication taken after withdrawal was disregarded for analysis purposes 2. The key secondary endpoint part 2: 2.1. The time of treatment failure was taken as the time of withdrawal or the timing of the inadmissible dose of study/rescue medication, whichever was earlier 2.2. Median score for subjects overall assessment per 24-hours period 2.3. Mean number of dose taken per 24-hours (including rescue) 2.4. Mean duration between doses per 24-hour period and overall (including rescue) 2.5. Peak PAR score per 24-hour period | — |
Countries
United States of America
Outcome results
None listed