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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Thir

Brief 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 Summary:

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.


Sponsor: Mundipharma Research GmbH & Co KG

Current Primary Outcome: Efficacy of MR308 doses in the treatment of moderate to severe acute pain, based on the Sum of Pain Intensity Differences (SPID). [ Time Frame: 0-4 hours ]

The primary efficacy endpoint is the Sum of Pain Intensity Differences over 0-4 hours (SPID4). SPID4 is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mundipharma Research GmbH & Co KG

Dates:
Date Received: November 25, 2016
Date Started: December 2016
Date Completion: February 2018
Last Updated: May 18, 2017
Last Verified: November 2016