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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled into one of five treatment groups by age and assigned to either 4 mg or 8 mg ramelteon.

Reporting Groups
  Description
Children Ramelteon 4 mg 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 Ramelteon 8 mg Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents Ramelteon 4 mg Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents Ramelteon 8 mg Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy Adult Ramelteon 8 mg Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.

Participant Flow:   Overall Study
    Children Ramelteon 4 mg   Children Ramelteon 8 mg   Adolescents Ramelteon 4 mg   Adolescents Ramelteon 8 mg   Healthy Adult Ramelteon 8 mg
STARTED   6   6   8   8   28 
COMPLETED   6   6   8   8   28 
NOT COMPLETED   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Children Ramelteon 4 mg Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
Children Ramelteon 8 mg Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
Adolescents Ramelteon 4 mg Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
Adolescents Ramelteon 8 mg Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
Healthy Adult Ramelteon 8 mg Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Total Total of all reporting groups

Baseline Measures
   Children Ramelteon 4 mg   Children Ramelteon 8 mg   Adolescents Ramelteon 4 mg   Adolescents Ramelteon 8 mg   Healthy Adult Ramelteon 8 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   8   8   28   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.8  (1.72)   9.2  (1.47)   15.8  (1.67)   15.5  (1.93)   30.9  (10.17)   21.7  (12.00) 
Gender 
[Units: Participants]
           
Female   3   1   5   4   13   26 
Male   3   5   3   4   15   30 
Ethnicity (NIH/OMB) 
[Units: Participants]
           
Hispanic or Latino   0   1   1   0   0   2 
Not Hispanic or Latino   6   5   7   8   28   54 
Unknown or Not Reported   0   0   0   0   0   0 
Race/Ethnicity, Customized 
[Units: 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 
[Units: Participants]
           
United States   6   6   8   8   28   56 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 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 
[Units: Cm]
Mean (Standard Deviation)
 128  (11.8)   141  (11.9)   168  (11.2)   170  (12.8)   174  (11.7)   164  (19.5) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 16.5  (2.19)   17.6  (3.75)   21.7  (2.53)   22.9  (2.94)   25.1  (3.05)   22.6  (4.29) 


  Outcome Measures

1.  Primary:   Maximum Observed Serum Concentration (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. ]

2.  Primary:   Time to Reach Maximum Serum Concentration (Tmax)   [ 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. ]

3.  Primary:   Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])   [ 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. ]

4.  Primary:   Area Under the Serum Concentration-time Curve From Time 0 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. ]

5.  Primary:   Apparent Clearance After Oral Administration (CL/F)   [ 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. ]

6.  Primary:   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. ]

7.  Primary:   Terminal Elimination Half-life (T1/2)   [ 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. ]

8.  Primary:   Apparent Volume of Distribution (Vz/F)   [ 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. ]

9.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: Day 1 to Day 15 ]

10.  Secondary:   Number of Participants With Clinically Significant Laboratory Findings   [ Time Frame: Screening, Day 1, Day 2 and Day 4 ]

11.  Secondary:   Number of Participants With Clinically Significant Vital Signs   [ Time Frame: Screening, Day 1, Day 2 and Day 4 ]

12.  Secondary:   Number of Participants With Clinically Significant Electrocardiogram Findings   [ Time Frame: Screening, Day 2 and Day 4 ]

13.  Secondary:   Number of Participants With Clinically Significant Physical Examination Results   [ Time Frame: Screening, Day 1, Day 2 and Day 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



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