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Trial record 14 of 854 for:    tablet | Japan

Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> − Transitional Survey From the Preceding Drug-use Survey −

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ClinicalTrials.gov Identifier: NCT02153086
Recruitment Status : Completed
First Posted : June 2, 2014
Results First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Insomnia
Intervention: Drug: Ramelteon

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 2 investigative sites in Japan from 01 March 2011 to 30 June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of insomnia which was associated with difficulty in falling asleep in daily clinical practice were enrolled in a single treatment group to receive ramelteon 8 milligram (mg).

Reporting Groups
  Description
Ramelteon 8 mg Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.

Participant Flow:   Overall Study
    Ramelteon 8 mg
STARTED   236 
COMPLETED   232 
NOT COMPLETED   4 
Not enrolled >=28 days and <=56 days                2 
Other                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis set was defined as all participants who were enrolled and completed the study.

Reporting Groups
  Description
Ramelteon 8 mg Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.

Baseline Measures
   Ramelteon 8 mg 
Overall Participants Analyzed 
[Units: Participants]
 232 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.1  (18.6) 
Gender 
[Units: Participants]
 
Female   139 
Male   93 
Type of sleep disorders (Major symptoms) [1] 
[Units: Participants]
 
Difficulty falling asleep   127 
Difficulty getting sound sleep   16 
Difficulty staying asleep   44 
Early morning awakening   2 
Unknown   43 
[1] Type of sleep disorders were classified on the basis of major symptoms as difficulty falling asleep, difficulty getting sound sleep, difficulty staying asleep, early morning awakening, and unknown.
Degree of sleep disorders [1] 
[Units: Participants]
 
Mild   72 
Moderate   130 
Severe   30 
[1] Degree of sleep disorders were categorized on the basis of severity, as mild, moderate or severe.
Duration of insomnia 
[Units: Participants]
 
Less than (<) 1 year   102 
Greater than equal to (>=) 1 year to <3 years   15 
>=3 to <5 years   14 
>=5 years   11 
Unknown   90 
Presence of complications 
[Units: Participants]
 
Had Complications   193 
Had No Complications   39 
Breakdown of complications [1] 
[Units: Participants]
 
Hypertension   86 
Dyslipidaemia   57 
Mental disease   32 
Allergic disease   23 
Diabetes mellitus   22 
Heart or cerebrovascular disease   22 
Renal and urinary disorders   17 
[1] Complications were categorized as hypertension, dyslipidaemia, mental disease, allergic disease, diabetes mellitus, heart or cerebrovascular disease, and renal and urinary disorders. Participants may be represented in more than 1 category.


  Outcome Measures

1.  Primary:   Number of Participants Reporting One or More Adverse Drug Reactions   [ Time Frame: Baseline up to 12 months ]

2.  Secondary:   Sleep Status: Sleep Onset Latency   [ Time Frame: Baseline, Week 4 and Month 12 ]

3.  Secondary:   Sleep Status: Total Sleep Time   [ Time Frame: Baseline, Week 4 and Month 12 ]

4.  Secondary:   Sleep Status: Number of Awakenings   [ Time Frame: Baseline, Week 4 and Month 12 ]

5.  Secondary:   Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset   [ Time Frame: At Week 4, 52, and final assessment (up to 12 months) ]

6.  Secondary:   Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration   [ Time Frame: At Week 4, 52, and final assessment (up to 12 months) ]

7.  Secondary:   Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality   [ Time Frame: At Week 4, 52, and final assessment (up to 12 months) ]

8.  Secondary:   Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening   [ Time Frame: At Week 4, 52, and final assessment (up to 12 months) ]

9.  Secondary:   Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning   [ Time Frame: At Week 4, 52, and final assessment (up to 12 months) ]

10.  Secondary:   Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence   [ Time Frame: At Week 4, 52, and final assessment (up to 12 months) ]

11.  Secondary:   Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function   [ Time Frame: At Week 4, 52, and final assessment (up to 12 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02153086     History of Changes
Other Study ID Numbers: 293-011
First Submitted: May 29, 2014
First Posted: June 2, 2014
Results First Submitted: August 17, 2016
Results First Posted: October 13, 2016
Last Update Posted: October 13, 2016