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A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia

This study has been completed.
Sponsor:
Information provided by:
Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT00869128
First received: December 8, 2008
Last updated: March 30, 2009
Last verified: March 2009
Results First Received: December 8, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Insomnia
Interventions: Drug: Circadin
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
36 independently living patients who complained of insomnia and suffered from type 2 diabetes (16 treated with oral hypoglycemic agents and 20 on insulin) entered the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with liver or renal disease (serum creatinine 1.5 mg/dL or higher) were excluded. All 36 patients were randomized and all concluded the crossover randomized and extension parts of the study.

Reporting Groups
  Description
Placebo First Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
Circadin First Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.

Participant Flow:   Overall Study
    Placebo First     Circadin First  
STARTED     18     18  
COMPLETED     12     12  
NOT COMPLETED     6     6  
lack of Compliance                 6                 6  



  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.
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Reporting Groups
  Description
Entire Study Population Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     22  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 8  
Gender  
[units: participants]
 
Female     25  
Male     11  
Region of Enrollment  
[units: participants]
 
Israel     36  



  Outcome Measures

1.  Primary:   Sleep Efficiency   [ Time Frame: 3 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
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  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: D. Garfinkel , MD
Organization: Shoham Geriatric Medical Center, Pardes Hana, Israel
phone: Tel: 972-4-6375667
e-mail: dorong@shoham.health.gov.il


No publications provided


Responsible Party: Dr. Doron Garfinkel, Shoham Geriatric Medical Center,Pardes Hana 37000, Israel
ClinicalTrials.gov Identifier: NCT00869128     History of Changes
Other Study ID Numbers: Neu951005
Study First Received: December 8, 2008
Results First Received: December 8, 2008
Last Updated: March 30, 2009
Health Authority: Israel: Ministry of Health