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 -

NCT02153086 | Completed Results

• 1 other identifier: 293-011
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 2

Brief 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 participants with difficulty falling asleep associated with insomnia in daily medical practice.

Conditions

Insomnia

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting One or More Adverse Drug Reactions

  Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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.

  Baseline up to 12 months

Secondary Outcomes (10)

• Sleep Status: Sleep Onset Latency

  Baseline, Week 4 and Month 12

• Sleep Status: Total Sleep Time

  Baseline, Week 4 and Month 12

• Sleep Status: Number of Awakenings

  Baseline, Week 4 and Month 12

• Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset

  At Week 4, 52, and final assessment (up to 12 months)

• Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration

  At Week 4, 52, and final assessment (up to 12 months)

Study Arms (1)

Ramelteon 8 mg Tablets

Drug: Ramelteon

Interventions

Ramelteon DRUG

Ramelteon tablets 8 mg

Also known as: Rozerem 8 mg Tablets

Ramelteon 8 mg Tablets

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Insomnia

You may qualify if:

• Participants 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

You may not qualify if:

• Participants with contraindications to Rozerem Tablets.
• Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets.
• Participants with severe liver dysfunction.
• Participants taking fluvoxamine maleate

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: March 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 13, 2016
• Results First Posted: October 13, 2016

Record last verified: 2016-08

Locations

JP (2)