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Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults

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ClinicalTrials.gov Identifier: NCT00914862
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : April 4, 2012
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Insomnia
Intervention Drug: Ramelteon
Enrollment 56

Recruitment Details Participants took part in the study at one investigative site in the United States from 02 November 2009 to 03 April 2011.
Pre-assignment Details Participants were enrolled into one of five treatment groups by age and assigned to either 4 mg or 8 mg ramelteon.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description Children 6 to 11 years of age who had insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) received a single 4 mg oral dose of ramelteon. Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon. Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon. Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Period Title: Overall Study
Started 6 6 8 8 28
Completed 6 6 8 8 28
Not Completed 0 0 0 0 0
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg Total
Hide Arm/Group Description Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon. Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon. Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon. Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon. Total of all reporting groups
Overall Number of Baseline Participants 6 6 8 8 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
7.8  (1.72) 9.2  (1.47) 15.8  (1.67) 15.5  (1.93) 30.9  (10.17) 21.7  (12.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
Female
3
  50.0%
1
  16.7%
5
  62.5%
4
  50.0%
13
  46.4%
26
  46.4%
Male
3
  50.0%
5
  83.3%
3
  37.5%
4
  50.0%
15
  53.6%
30
  53.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
Hispanic or Latino
0
   0.0%
1
  16.7%
1
  12.5%
0
   0.0%
0
   0.0%
2
   3.6%
Not Hispanic or Latino
6
 100.0%
5
  83.3%
7
  87.5%
8
 100.0%
28
 100.0%
54
  96.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
Black or African American 3 1 0 0 5 9
White 1 5 8 8 23 45
Multiracial 2 0 0 0 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
6 6 8 8 28 56
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
28.1  (7.40) 36.6  (12.24) 61.4  (11.14) 66.4  (12.99) 76.8  (13.85) 63.6  (21.40)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
128  (11.8) 141  (11.9) 168  (11.2) 170  (12.8) 174  (11.7) 164  (19.5)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 6 participants 8 participants 8 participants 28 participants 56 participants
16.5  (2.19) 17.6  (3.75) 21.7  (2.53) 22.9  (2.94) 25.1  (3.05) 22.6  (4.29)
1.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax)
Hide Description Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.
Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) set, which consisted of all patients who received study drug and had sufficient concentration data to calculate at least 1 PK parameter.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
Ramelteon (n=6, n=6, n=8, n=8, n=28) 0.702  (0.8145) 0.998  (1.0106) 0.413  (0.4310) 0.759  (0.5112) 1.681  (2.3822)
M-II (n=6, n=6, n=8, n=8, n=28) 52.5  (21.83) 79.0  (56.94) 21.5  (6.54) 39.6  (7.63) 40.8  (14.53)
2.Primary Outcome
Title Time to Reach Maximum Serum Concentration (Tmax)
Hide Description Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.
Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set where valid PK parameter estimates were available.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Median (Full Range)
Unit of Measure: hours
Ramelteon (n=6, n=6, n=7, n=8, n=28)
0.50
(0.50 to 2.00)
0.50
(0.50 to 2.00)
2.00
(0.50 to 3.00)
1.00
(0.50 to 2.00)
1.00
(0.50 to 3.00)
M-II (n=6, n=6, n=8, n=8, n=28)
0.75
(0.50 to 2.00)
1.00
(0.50 to 2.00)
2.00
(1.00 to 8.00)
2.00
(0.50 to 2.00)
2.00
(0.50 to 4.00)
3.Primary Outcome
Title Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])
Hide Description Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.
Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set where valid PK parameter estimates were available.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Ramelteon (n=6, n=6, n=8, n=8, n=28) 0.703  (0.7098) 1.353  (1.0621) 1.022  (0.9553) 1.564  (1.0591) 3.636  (3.9104)
M-II (n=6, n=6, n=8, n=8, n=28) 127.2  (57.81) 223.4  (61.84) 88.8  (41.43) 175.4  (43.39) 190.6  (62.95)
4.Primary Outcome
Title Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC[0-inf])
Hide Description Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).
Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set where valid PK parameter estimates were available.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 7 8 28
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Ramelteon (n=4, n=5, n=4, n=8, n=25) 1.03  (0.740) 1.65  (1.104) 1.75  (0.812) 1.69  (1.051) 4.22  (3.986)
M-II (n=6, n=6, n=8, n=8, n=28) 131.0  (59.67) 227.6  (62.57) 92.4  (43.68) 179.2  (43.81) 195.4  (65.06)
5.Primary Outcome
Title Apparent Clearance After Oral Administration (CL/F)
Hide Description

Apparent oral clearance of drug from the serum calculated as:

CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]).

Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set where valid PK parameter estimates were available.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 4 5 4 8 25
Mean (Standard Deviation)
Unit of Measure: L/hr
5374  (3117.6) 6883  (4112.3) 2605  (931.5) 7319  (5426.6) 4086  (3793.6)
6.Primary Outcome
Title Terminal Elimination Rate Constant (λz)
Hide Description The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set where valid PK parameter estimates were available.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Mean (Standard Deviation)
Unit of Measure: 1/hour
Ramelteon (n=4, n=5, n=4, n=8, n=25) 0.743  (0.2181) 0.659  (0.07205) 0.550  (0.1358) 0.541  (0.1651) 0.483  (0.1234)
M-II (n=6, n=6, n=8, n=8, n=28) 0.436  (0.1109) 0.363  (0.0771) 0.377  (0.1217) 0.331  (0.0936) 0.278  (0.0400)
7.Primary Outcome
Title Terminal Elimination Half-life (T1/2)
Hide Description Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln[2]) / Terminal elimination rate constant (λz).
Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set where valid PK parameter estimates were available.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Mean (Standard Deviation)
Unit of Measure: hours
Ramelteon (n=4, n=5, n=4, n=8, n=25) 1.02  (0.399) 1.06  (0.117) 1.32  (0.343) 1.41  (0.490) 1.52  (0.341)
M-II (n=6, n=6, n=8, n=8, n=28) 1.72  (0.635) 1.98  (0.383) 1.99  (0.536) 2.21  (0.454) 2.55  (0.385)
8.Primary Outcome
Title Apparent Volume of Distribution (Vz/F)
Hide Description Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).
Time Frame Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set where valid PK parameter estimates were available.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 4 5 4 8 25
Mean (Standard Deviation)
Unit of Measure: Liters
9136  (8703.1) 10912  (6923.3) 5016  (2462.4) 14294  (10591.2) 8606  (8417.1)
9.Secondary Outcome
Title Number of Participants With Adverse Events (AE)
Hide Description

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows:

Mild: The event was transient and easily tolerated by the participant.

Moderate: The event causes the participant discomfort and interrupted usual activities.

Severe: The event causes considerable interference with the participant’s usual activities.

Time Frame Day 1 to Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety set includes all participants who received at least 1 dose of study drug.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Measure Type: Number
Unit of Measure: participants
Any AE 0 1 1 0 3
Mild AE 0 1 1 0 2
Moderate AE 0 0 0 0 1
Severe AE 0 0 0 0 0
Leading to discontinuation 0 0 0 0 0
10.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Findings
Hide Description Laboratory samples were collected at Screening, Check-in (Day 1), and Day 2 or Early Termination for assessment of hematology, chemistry, and urinalysis.
Time Frame Screening, Day 1, Day 2 and Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
11.Secondary Outcome
Title Number of Participants With Clinically Significant Vital Signs
Hide Description Vital signs included oral body temperature, pulse and blood pressure (taken after 5 minutes in the sitting position). Vital signs measurements were determined to be clinically significant according to predefined criteria.
Time Frame Screening, Day 1, Day 2 and Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
12.Secondary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram Findings
Hide Description A standard 12-lead electrocardiogram (ECG) was recorded at Screening, Day 2, and at Final Visit (Day 4). The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Time Frame Screening, Day 2 and Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
13.Secondary Outcome
Title Number of Participants With Clinically Significant Physical Examination Results
Hide Description A complete physical examination was performed for each participant at Screening, Check-in (Day 1), Day 2, and Final Visit (Day 4) or Early Termination. The examination consisted of a review of the following body systems: eyes; ears, nose, and throat; respiratory; gastrointestinal; extremities; musculoskeletal; cardiovascular; nervous; and dermatological.
Time Frame Screening, Day 1, Day 2 and Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set.
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description:
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Overall Number of Participants Analyzed 6 6 8 8 28
Measure Type: Number
Unit of Measure: participants
0 0 0 1 1
Time Frame Day 1 to Day 15.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Hide Arm/Group Description Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon. Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon. Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon. Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
All-Cause Mortality
Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Children Ramelteon 4 mg Children Ramelteon 8 mg Adolescents Ramelteon 4 mg Adolescents Ramelteon 8 mg Healthy Adult Ramelteon 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/6 (16.67%)   1/8 (12.50%)   0/8 (0.00%)   0/28 (0.00%) 
Gastrointestinal disorders           
Dyspepsia  1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/28 (0.00%) 
General disorders           
Fatigue  1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/28 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00914862     History of Changes
Other Study ID Numbers: TAK-375_110
U1111-1112-5188 ( Registry Identifier: WHO )
First Submitted: June 3, 2009
First Posted: June 5, 2009
Results First Submitted: March 7, 2012
Results First Posted: April 4, 2012
Last Update Posted: April 4, 2012