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

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 Abdo

Brief 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 Summary:

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.


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) from 0-4 hours. [ 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: February 20, 2017
Date Started: April 5, 2017
Date Completion: August 2018
Last Updated: April 6, 2017
Last Verified: February 2017