Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

NCT02058992 | Completed Results

• 3 other identifiers: 293-101JapicCTI-132358JapicCTI-R150751
• Study Type: observational
• Target: 3,339
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Insomnia

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting One or More Adverse Drug Reactions

  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.

  Baseline up to 6 weeks

• Number of Participants Reporting One or More Serious Adverse Drug Reactions

  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.

  Baseline up to 6 weeks

Secondary Outcomes (4)

• Sleep Status: Sleep Onset Latency

  Baseline and Week 4

• Sleep Status: Total Sleep Time

  Baseline and Week 4

• Sleep Status: Number of Awakenings

  Baseline and Week 4

• Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4

  Week 4

Study Arms (1)

Ramelteon 8 mg administered orally once daily

Drug: Ramelteon

Interventions

Ramelteon DRUG

Ramelteon 8 mg tablets

Also known as: Rozerem

Ramelteon 8 mg administered orally once daily

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:

• \. Sleep-onset difficulty associated with insomnia

You may not qualify if:

• Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
• Patients with severe liver dysfunction
• Patients taking fluvoxamine maleate

Sponsors & Collaborators

• Takeda: lead

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: February 7, 2014
• First Posted: February 11, 2014
• Study Start: July 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 14, 2016
• Results First Posted: July 14, 2016

Record last verified: 2016-06