Acute Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Multicenter, Placebo- and Active Comparator-Controlled Study to Evaluate Efficacy and Safety of MR308 in the Treatment of Acute Pain After Third Molar Tooth Extraction (STARDOM1).
The MR308-3501 study is a multicenter, randomised, double-blind, parallel-group study in male and female adult subjects to demonstrate the efficacy of MR308 in the treatment of acute moderate to severe pain after the extraction of at least two third molars requiring bone removal.
This is a multicenter double-blind, randomised, phase III study in male and female subjects
with acute pain after third molar tooth extraction. The dental procedure must have involved
extraction of at least two impacted third molars requiring bone removal. If only two impacted
third molars are extracted, they must be ipsilateral and both require bone removal under
local anaesthesia.
The Screening Visit (Visit 1) can take place up to 28 days before the planned third molar
extractions. The randomisation visit (Visit 2) consists of three different sections, a part
before the surgery, the part with the surgery and before randomisation, and a part with the
randomisation and post-randomisation assessments. The visits 3 and 4, one respectively two
days after the randomisation can be performed by telephone if the subject does not
participate in the pharmacokinetic sampling.
The last dose of IMP should be taken by the subject about 72h after the initial dose and
before the Completion/Discontinuation Visit (Visit 5) is performed.
The Adverse Event (AE) Follow-up Visit (Visit 6) is the last study visit and should not be
done earlier than seven days after the subject's last dose of IMP. It can be performed by
telephone.
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