NCT03062644

Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2.

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,138 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	MR308	two times daily; Mode of Administration:oral
DRUG	MR308	four times daily; Mode of Administration:oral
DRUG	MR308	two times daily; Mode of Administration:oral
DRUG	MR308	given four times daily to maintain the blind; Mode of Administration:oral

Timeline

• Start date: 2017-04-05
• Primary completion: 2018-06-29
• Completion: 2018-06-29
• First posted: 2017-02-23
• Last updated: 2018-09-20

Locations

8 sites across 8 countries: Belarus, Bulgaria, Canada, Hungary, Latvia, Poland, Russia, Spain