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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
The purpose of this study to determine the long-term efficacy and safety of ramelteon, once
daily (QD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00247390
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00247390