CLINICAL TRIALS PROFILE FOR ROZEREM

505(b)(2) Clinical Trials for rozerem

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02840591 ↗	Ramelteon and Citicoline for Delirium	Withdrawn	University of Texas Southwestern Medical Center	Phase 4	2016-07-01	Primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at Clements University Hospital in Dallas, Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or an over-the-counter supplement called Citicoline are safe and beneficial in delirium.

All Clinical Trials for rozerem

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00237497 ↗	Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia	Completed	Takeda	Phase 3	2005-07-01	The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia
NCT00247390 ↗	Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.	Completed	Takeda	Phase 3	2005-07-01	The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
NCT00316992 ↗	Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease	Completed	Takeda	Phase 4	2006-04-01	The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.

Clinical Trial Conditions for rozerem

Condition Name

Condition Name for rozerem
Intervention	Trials
Insomnia	13
Chronic Insomnia	7
Delirium	4

Condition MeSH

Condition MeSH for rozerem
Intervention	Trials
Sleep Initiation and Maintenance Disorders	24
Disease	10
Delirium	5

Clinical Trial Locations for rozerem

Trials by Country

Trials by Country for rozerem
Location	Trials
United States	193
Russian Federation	5
Japan	4
United Kingdom	3
Germany	3

Trials by US State

Trials by US State for rozerem
Location	Trials
California	13
Ohio	11
Florida	10
New York	9
Texas	8

Clinical Trial Progress for rozerem

Clinical Trial Phase

Clinical Trial Phase for rozerem
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	12
Phase 2	7

Clinical Trial Status

Clinical Trial Status for rozerem
Clinical Trial Phase	Trials
Completed	29
Terminated	9
Unknown status	4

Clinical Trial Sponsors for rozerem

Sponsor Name

Sponsor Name for rozerem
Sponsor	Trials
Takeda	29
Takeda Pharmaceuticals North America, Inc.	4
Brigham and Women's Hospital	2

Sponsor Type

Sponsor Type for rozerem
Sponsor	Trials
Industry	33
Other	29
U.S. Fed	4