Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153086
Other study ID # 293-011
Secondary ID
Status Completed
Phase N/A
First received May 29, 2014
Last updated August 1, 2014
Start date March 2011
Est. completion date June 2014

Study information

Verified date August 2014
Source Takeda
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in patients with difficulty falling asleep associated with insomnia in daily medical practice.


Description:

This survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in patients with difficulty falling asleep associated with insomnia in daily medical practice.

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


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets

Exclusion Criteria:

- Patients with contraindications to Rozerem Tablets

1. Patients with previous history of hypersensitivity to ingredients in Rozerem Tablets

2. Patients with severe liver dysfunction

3. Patients taking fluvoxamine maleate

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Ramelteon
Ramelteon tablets 8 mg

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of adverse drug reactions The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of ramelteon whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with ramelteon are defined as adverse drug reactions. For 6 months (for 1 year in patients for whom follow-up can be performed) Yes
Secondary Sleep status (sleep latency, total sleep time, and number of awakenings) Changes from baseline in sleep status from the start of the surveillance will be tabulated and assessed. From baseline to 6 months of treatment (for 1 year in patients for whom follow-up can be performed) No
Secondary Change from baseline in patient global impression (PGI) score Results of surveys using the PGI questionnaire will be scored, and scores for 7 items (sleep onset, sleep duration, sleep quality, morning awakening, remaining tiredness in the morning, daytime somnolence, and daytime physical condition/function) will be tabulated and assessed. From baseline to 6 months of treatment (for 1 year in patients for whom follow-up can be performed) No
See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A