Trial Outcomes & Findings for Ramelteon for Treatment of Insomnia in Cirrhosis (NCT NCT03091738)

Last Updated: 2021-03-29

Results Overview

Pittsburgh Sleep Quality Index (PSQI) is a 19 item survey measuring 7 components of sleep. Component scores are summed to yield a global PSQI score. Scores range from 0 to 21 with higher scores indicate worse sleep quality.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

14 days

Results posted on

2021-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Ramelteon Pill Patients given ramelteon and re-evaluated after 15 days of therapy Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ramelteon Pill Patients given ramelteon and re-evaluated after 15 days of therapy Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Ramelteon for Treatment of Insomnia in Cirrhosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramelteon Pill n=10 Participants Patients given ramelteon and re-evaluated after 15 days of therapy Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	Ramelteon Pill n=8 Participants Patients given ramelteon and re-evaluated after 15 days of therapy Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon
Sleep Quality Evaluation Baseline	4.63 score on a scale Standard Deviation 2.97
Sleep Quality Evaluation Day 14	11.75 score on a scale Standard Deviation 4.68

SECONDARY outcome

Timeframe: 14 days

Epworth Sleepiness Scale asks participants to rate (on a scale of 0 to 3) their likelihood of falling asleep during 8 daily activities. Scores range from 0 to 24 with lower scores indicating less sleepiness.

Outcome measures

Outcome measures
Measure	Ramelteon Pill n=8 Participants Patients given ramelteon and re-evaluated after 15 days of therapy Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon
Daytime Sleepiness Evaluation Baseline	4.68 score on a scale Standard Deviation 2.63
Daytime Sleepiness Evaluation Day 14	5.8 score on a scale Standard Deviation 3.39

SECONDARY outcome

Timeframe: 14 days

Sickness Impact Profile is a 68 question assessment. Items are scored 0 (no) or 1 (yes). Scores range from 0 to 68 with higher numbers indicating worse quality of life.

Outcome measures

Outcome measures
Measure	Ramelteon Pill n=8 Participants Patients given ramelteon and re-evaluated after 15 days of therapy Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon
Sickness Impact Profile Baseline	4.9 score on a scale Standard Deviation 6.85
Sickness Impact Profile Day 14	3.96 score on a scale Standard Deviation 7.03

Adverse Events

Ramelteon Pill

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ramelteon Pill n=10 participants at risk Patients given ramelteon and re-evaluated after 15 days of therapy Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon
Product Issues Paradoxical reaction	10.0% 1/10 • Number of events 1 • 14 days

Additional Information

Jasmohan Bajaj, MD

Virginia Commonwealth University

Phone: 804-828-4060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place