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 Abdominal Hysterectomy Surgery Under General Anaesthesia (STARDOM2).
The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).
This is a multicenter double-blind, randomised, placebo- and active comparator-controlled
study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after
total or subtotal abdominal hysterectomy (TAH or STAH).
The screening Visit (Visit 1) can take place up to 28 days before the planned TAH or STAH.
The surgery will be performed at Visit 2. Visit 2 consists of three different sections, a
part before the surgery, the surgery and post surgery. On the next Day (Visit 3) subjects
will qualify for further participation by regular measurements of their pain. Subjects
meeting all eligibility criteria, such as defined pain levels, will be randomised to one of
six treatment groups and be given IMPs for 120h. Subjects who will not be randomised are
screen failures and will be given standard care as per local practice.
Visits 4, 5, 6 ,7 and 8, one to five days after randomisation will be performed to record
efficacy and safety parameters.
The last dose of IMP should be taken by the subject about 120h after the initial dose and
before Visit 8 (Completion/Discontinuation Visit) is performed.
The Adverse Event (AE) Follow up Visit (Visit 9) 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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