Clinical Trial: Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Randomized, Open-label Clinical Study With a Concurrent Control Group to Assess the Effectiveness and Safety of Combined Therapy With Isobide Solution and Meniace Tablets Compared to Mo
Brief Summary: A multicenter, randomized, open-label clinical study with a concurrent control group to assess the effectiveness and safety of combined therapy with Isobide solution and Meniace tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease
Detailed Summary:
Sponsor: Alvogen Korea
Current Primary Outcome: the number of vertigo episodes [ Time Frame: The difference between the number of vertigo episodes experienced during the 4 weeks before the screening and the number of vertigo episodes during the 4 weeks after administration of the study drug ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Alvogen Korea
Dates:
Date Received: March 21, 2016
Date Started: February 2013
Date Completion:
Last Updated: March 23, 2016
Last Verified: March 2016