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Trial record 1 of 1 for:    293-101
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Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02058992
First Posted: February 11, 2014
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

Condition Intervention
Insomnia Drug: Ramelteon

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants Reporting One or More Adverse Drug Reactions [ Time Frame: Baseline up to 6 weeks ]
    Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

  • Number of Participants Reporting One or More Serious Adverse Drug Reactions [ Time Frame: Baseline up to 6 weeks ]
    Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Secondary Outcome Measures:
  • Sleep Status: Sleep Onset Latency [ Time Frame: Baseline and Week 4 ]
    Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.

  • Sleep Status: Total Sleep Time [ Time Frame: Baseline and Week 4 ]
    Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.

  • Sleep Status: Number of Awakenings [ Time Frame: Baseline and Week 4 ]
    Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.

  • Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 [ Time Frame: Week 4 ]
    PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition.


Enrollment: 3339
Study Start Date: July 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ramelteon 8 mg administered orally once daily Drug: Ramelteon
Ramelteon 8 mg tablets
Other Name: Rozerem

Detailed Description:

This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)

The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Insomnia
Criteria

Inclusion Criteria:

1. Sleep-onset difficulty associated with insomnia

Exclusion Criteria:

  1. Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
  2. Patients with severe liver dysfunction
  3. Patients taking fluvoxamine maleate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058992


Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02058992     History of Changes
Other Study ID Numbers: 293-101
JapicCTI-132358 ( Registry Identifier: JapicCTI )
JapicCTI-R150751 ( Registry Identifier: JapicCTI )
First Submitted: February 7, 2014
First Posted: February 11, 2014
Results First Submitted: December 7, 2015
Results First Posted: July 14, 2016
Last Update Posted: July 14, 2016
Last Verified: June 2016

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders