NCT02982161

Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib).

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 818 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	MR308	Over-encapsulated tablet, Dosing frequency: two times daily, Mode of administration: oral
DRUG	Tramadol	Over-encapsulated capsule, Dosing frequency: four times daily, Mode of administration: oral
DRUG	Placebo	Capsule, Dosing frequency: four times daily, Mode of administration: oral

Timeline

• Start date: 2016-12-28
• Primary completion: 2018-01-04
• Completion: 2018-01-04
• First posted: 2016-12-05
• Last updated: 2018-05-29

Locations

7 sites across 6 countries: Canada, Germany, Hungary, Italy, Poland, Spain