Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00247390




Registration number
NCT00247390
Ethics application status
Date submitted
28/10/2005
Date registered
1/11/2005
Date last updated
3/06/2010

Titles & IDs
Public title
Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
Scientific title
A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
Secondary ID [1] 0 0
2004-004351-20
Secondary ID [2] 0 0
TAK-375-EC302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Insomnia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ramelteon
Treatment: Drugs - Placebo

Experimental: Ramelteon 8 mg QD -

Placebo comparator: Placebo QD -


Treatment: Drugs: Ramelteon
Ramelteon 8 mg, tablets, orally, once daily for up to 42 weeks.

Treatment: Drugs: Placebo
Ramelteon placebo-matching tablets, orally, once daily for up to 42 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in Latency to Persistent Sleep of 2-night polysomnogram.
Timepoint [1] 0 0
Months 3 and 6 or Final Visit
Secondary outcome [1] 0 0
Mean change in Total Sleep Time from polysomnogram, on 2 nights over 6 months.
Timepoint [1] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [2] 0 0
Mean change in Subjective Sleep Latency by postsleep questionnaire on 2 nights over 6 months.
Timepoint [2] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [3] 0 0
Mean change in Subjective Total Sleep Time by postsleep questionnaire on 2 nights over 6 months.
Timepoint [3] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [4] 0 0
Mean change in Subjective Number of Awakenings by postsleep questionnaire.
Timepoint [4] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [5] 0 0
Mean change in Subjective Sleep Quality by postsleep questionnaire.
Timepoint [5] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [6] 0 0
Total Sleep Time in rapid eye movement (REM) sleep as determined by polysomnogram.
Timepoint [6] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [7] 0 0
Total Sleep Time in stage 1 non-rapid eye movement (NREM) sleep as determined by polysomnogram.
Timepoint [7] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [8] 0 0
Total Sleep Time in stage 2 non-rapid eye movement (NREM) sleep as determined by polysomnogram.
Timepoint [8] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [9] 0 0
Total Sleep Time in stage 3/4 non-rapid eye movement (NREM) sleep as determined by polysomnogram.
Timepoint [9] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [10] 0 0
Total Sleep Time in stage 1 sleep as determined by polysomnogram.
Timepoint [10] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit
Secondary outcome [11] 0 0
Latency to Rapid Eye Movement as determined by polysomnogram.
Timepoint [11] 0 0
Week 1 and Months 1, 3, 5 and 6 or Final Visit

Eligibility
Key inclusion criteria
Inclusion Criteria

* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Body mass index between 18 and 34, inclusive.
* Based on sleep history, has had chronic insomnia for at least 3 months.
* Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min and a subjective total sleep time less than or equal to 6.5 hours.
* Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
* Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
* Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
* Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
* Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
* Flown across greater than three time zones within 7 days prior to or during screening.
* Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication.
* Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia.
* History of psychiatric disorder within the past 6 months.
* History of alcohol abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of any polysomnogram visits.
* History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised.
* Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
* Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
* Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
* Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits.
* Positive breathalyzer test on any of the polysomnogram assessment visits.
* Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings.
* Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
* Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must report all prescription and over the counter medications taken in the three weeks prior to screening.
* Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

* Anxiolytics
* Sedatives
* Hypnotics
* CNS active drugs (including herbal)
* Antidepressants
* Narcotic analgesics
* Anticonvulsants
* Beta blockers
* Sedating H1 antihistamines
* St. John's Wort
* Systemic steroids
* Kava-kava
* Respiratory stimulants
* Ginkgo-biloba
* Decongestants
* Over-the-counter and prescription stimulants
* Antipsychotics
* Over-the-counter and prescription diet aids
* Muscle Relaxants
* Melatonin and all other drugs or supplements known to affect sleep/wake function
* Any additional condition(s) that in the Investigator's opinion would

* affect sleep/wake function
* prohibit the subject from completing the study
* indicate that continuation in the study would not be in the best interests of the subject.
* History of hepatitis B or hepatitis C.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
451
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Ceske Budejovice
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Ostrava-Poruba
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Praha 2
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Praha
Country [20] 0 0
Finland
State/province [20] 0 0
Espoo
Country [21] 0 0
Finland
State/province [21] 0 0
Helsinki
Country [22] 0 0
Finland
State/province [22] 0 0
Turku
Country [23] 0 0
France
State/province [23] 0 0
Bron
Country [24] 0 0
France
State/province [24] 0 0
Clamart Cedex
Country [25] 0 0
France
State/province [25] 0 0
Garches
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Rouffach
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Goettingen
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Munster
Country [32] 0 0
Germany
State/province [32] 0 0
Schwalmstadt
Country [33] 0 0
Germany
State/province [33] 0 0
Schwerin
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Irkutsk
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Moscow
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Saint Petersburg
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Samara
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Yekateringburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00247390