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Clinical Management of Neuropathic Pain With Ramelteon

This study has been terminated.
(Recruitment did not accrue as expected.)
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00753623
First received: September 15, 2008
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Neuropathic Pain
Interventions: Drug: Ramelteon
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited in person at the MGH Center for Pain or by advertisement throughout MGH and the local community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Placebo-ramelteon

In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.

Ramelteon : ramelteon (8 mg)

Ramelton-placebo

In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.

Ramelteon : ramelteon (8 mg)


Participant Flow for 3 periods

Period 1:   First Intervention (14 Days)
    Placebo-ramelteon     Ramelton-placebo  
STARTED     11     12  
COMPLETED     9     8  
NOT COMPLETED     2     4  
Withdrawal by Subject                 1                 1  
Physician Decision                 1                 2  
Adverse Event                 0                 1  

Period 2:   Washout (7 Days)
    Placebo-ramelteon     Ramelton-placebo  
STARTED     9     8  
COMPLETED     8     8  
NOT COMPLETED     1     0  
Physician Decision                 1                 0  

Period 3:   Second Intervention (14 Days)
    Placebo-ramelteon     Ramelton-placebo  
STARTED     8     8  
COMPLETED     8     7  
NOT COMPLETED     0     1  
Physician Decision                 0                 1  



  Baseline Characteristics
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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.
N/A

Reporting Groups
  Description
Placebo

In a crossover design, a subject was first assigned to the placebo or ramelteon and then switched over to the opposite arm.

Ramelteon : ramelteon (8 mg)

Ramelteon

In a crossover design, a subject was first assigned to the placebo or ramelteon and then switched over to the opposite arm.

Ramelteon : ramelteon (8 mg)

Placebo and Ramelteon

In a crossover design, a subject was first assigned to the placebo or ramelteon and then switched over to the opposite arm.

Ramelteon : ramelteon (8 mg)

Total Total of all reporting groups

Baseline Measures
    Placebo     Ramelteon     Placebo and Ramelteon     Total  
Number of Participants  
[units: participants]
  3     4     16     23  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     4     16     23  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 6.9     55.2  ± 7.2     47.4  ± 12.4     48.5  ± 11.3  
Gender  
[units: participants]
       
Female     2     2     8     12  
Male     1     2     8     11  
Region of Enrollment  
[units: participants]
       
United States     3     4     16     23  



  Outcome Measures

1.  Primary:   Visual Analog Scale for Pain (0-10)   [ Time Frame: Participants were followed for up to 5 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Problems with recruitment and termination of the study consequently resulted in uninterpretable data.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Jianren Mao
Organization: MGH Center for Translational Pain Research
phone: 617-724-6102
e-mail: mghpainresearch@partners.org


No publications provided


Responsible Party: Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00753623     History of Changes
Other Study ID Numbers: 2008P-000988
Study First Received: September 15, 2008
Results First Received: November 1, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board