Ramelteon for Treatment of Insomnia in Cirrhosis
Phase: PHASE4
Conditions: Cirrhosis
Sponsor: Virginia Commonwealth University

 
 
Title: Study of Sleep in Cirrhosis 
 
NCT #: NCT03091738 
 
Document date: 09/04/2013 
 
Document Type: Study Protocol and Statistical Analysis Plan 
 
 
 

 
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Employee V#
3. If "Other Unique Identifier" was selected above, describe the identifiers  
4. * Will participants be able to withdraw their data (paper, electronic, or specimens) from the study if they no
longer wish to participate  
  Yes
No
5. If yes above, describe how participants will be able to withdraw their data  
they can contact the PI in writing as indicated in the consent form for withdrawal of all their data including genetic data.
  

 
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Individuals with limited English proficiency
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Active military personnel
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Student populations in K-12 educational settings or other learning environments
7. * Does this study obtaining data in, or from, the European Economic Area? (see Help Text for list of countries
included in the EEA) 
  Yes No
8. Justify the inclusion and exclusion criteria if necessary. If you are either targeting, or excluding, a particular
segment of the population / community, provide a description of the group/organization/community and
provide a rationale  
The PI only sees adults in his practice, pregnancy can cause increase in reflux symptoms that can worsen sleep
regardless of cirrhosis, and we cannot ensure that prisoners can take the medications as needed for this study.
9. * Select the age range(s) of the participants who may be involved in this study  
 
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< 1 Year
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1 - 6 Years
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7 - 12 Years
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13 - 17 Years
18 - 20 Years
21 - 65 Years
> 65 Years
  

unnecessary treatments and can in turn worsen their quality of life. A study with treatment with an FDA-approved
medication, will be able to identify and possibly correct the underlying sleep disturbances both pathophysiologically as
well as therapeutically. 
The minor risk to confidentiality and privacy and adverse effects of ramelteon are low compared to the potential
benefits of elucidating the mechanism and treatment options for these patients and potentially improve their QOL.
13. * Describe the scientific benefit or importance of the knowledge to be gained  
Sleep quality is a major concern in patients with cirrhosis and this impacts their quality of life immensely. Patients with
sleep problems are not able to function normally and this is often mistaken for hepatic encephalopathy. This leads to
unnecessary treatments and can in turn worsen their quality of life. A study with treatment with an FDA-approved
medication, will be able to identify and possibly correct the underlying sleep disturbances both pathophysiologically as
well as therapeutically. 
The minor risk to confidentiality and privacy and adverse effects of ramelteon are low compared to the potential
benefits of elucidating the mechanism and treatment options for these patients and potentially improve their QOL.
14. If applicable, describe alternatives (research or non-research) that are available to potential participants if they
choose not to participate in this study  
15. * Indicate if this study will have a Data Safety Monitoring Board (DSMB) or a Data Safety Monitoring Plan
(DSMP)  [Required for all greater than minimal risk studies] 
 
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DSMB
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DSMP
No DSMB/DSMP [Note  This response is not applicable for greater than minimal risk studies]