Pain Clinical Trial
Official title:
A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multiple-Dose, Active and Placebo-Controlled Efficacy Study of Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars
This is a single centre, randomised, double-blind, double-dummy, parallel group, multiple-dose, active and placebo-controlled efficacy study to evaluate the efficacy and safety of 2×300mg ibuprofen Prolonged Release (PR) tablets in subjects with postoperative dental pain.
This is a single centre, randomised, double blind, double-dummy, parallel group ,
multiple-dose, active and placebo controlled efficacy study to evaluate the efficacy and
safety of ibuprofen 2×300 mg ibuprofen PR tablets in subjects with postoperative dental pain.
Eligible subjects will complete all screening procedures within 28 days before the surgery
and randomisation.
At Screening, subjects will provide written informed consent to participate in the study
before any protocol specified procedures or assessments are completed. On Day 1, subjects who
continue to be eligible for study participation after completing screening procedures and
assessments will undergo extraction of 2 or more third molars. At least 1 of the third molars
must be a fully or partially bone impacted mandibular molar. If only 2 molars are removed,
then they must be ipsilateral.
All subjects will receive local anaesthesia (2% lidocaine with 1:100,000 epinephrine).
Nitrous oxide will be allowed at the discretion of the investigator. Subjects who experience
moderate to severe pain intensity (a score of ≥ 5 on a numeric rating scale [NRS] from 0-10
where 0 = no pain, 10 = worst pain ever) within 6 hours after surgery and who continue to
meet all study entry criteria will be randomised in a 3:3:1 ratio to receive 2×300 mg
ibuprofen PR tablets every 12 hours (Q12h), 2×200 mg ibuprofen IR tablets every 8 hours
(Q8h), or placebo. The randomisation will be stratified by baseline pain category (moderate
or severe) using a categorical scale that includes the categories of none (0), mild (1-4),
moderate (5-7), and severe (8-10).
Subjects will re-assess their baseline pain intensity using the NRS immediately before
receiving study drug (pre-dose, Time 0) and their pain intensity (NRS) and pain relief (5
point categorical scale) at the following time points (pre-dose, if at one of the dosing
timepoints of 0, 8, 12 and/or 16 hours): 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6,
7, 8, 10, 12, 16, and 24 hours after Time 0; and immediately before each dose of rescue
medication, if any. For assessments less than 1 hour apart a window of +/-2 min is allowable
whilst for assessments at least 1 hour apart a +/-5 min window is allowable.
The double stopwatch method will be used to record the time to perceptible pain relief and
time to meaningful pain relief during the 8 hours following the first dose or until subject
takes rescue medication. Subjects will complete a global evaluation of study drug 24 hours
(+/- 5 minutes) after Time 0 or immediately before the first dose of rescue medication
(whichever occurs first). Vital signs will be recorded after the subject has been in a
sitting position for 3 minutes at the following times: before surgery, within 30 minutes
before Time 0, 12 and 24 hours after Time 0, and/or immediately before the first dose of
rescue medication. Adverse events (AEs) will be monitored and recorded from the time of
signing of the informed consent form (ICF) until the Follow up Visit (or Early Termination
Visit). During the 24 hours following Time 0, subjects will complete efficacy and safety
assessments. Subjects will remain at the study site overnight and will be discharged on Day
2.
Paracetamol / acetaminophen (1000 mg) will be permitted as the initial rescue medication.
Subjects will be encouraged to wait at least 60 minutes after receiving study drug before
taking rescue medication. If acetaminophen rescue medication is not effective in relieving
the subject's pain, 5 mg oxycodone rescue medication may be administered at the discretion of
the investigator.
Subjects are not permitted to take any concomitant medications that might confound
assessments of pain relief, 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 (other than those used at the surgery). Selective
serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors
(SNRIs) are permitted if the subject has been on a stable dose for at least four weeks prior
to Visit 1 (screening).
Other restrictions include the following: alcohol use is prohibited from 24 hours before
surgery until discharge on Day 2; nothing by mouth from midnight before surgery until 1 hour
after surgery; clear liquids only are allowed starting 1 hour after surgery until 1 hour
after dosing; 1 hour after dosing, the subject's diet may be advanced according to standard
practice.
Upon discharge from the study site, subjects may be prescribed pain medication for use at
home according to the standard practice of the study site. On Day 8 (± 2 days), subjects will
return to the study site for an abbreviated confirmatory physical assessment and AE
assessments.
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