Trial Outcomes & Findings for Ramelteon for Insomnia Comorbid With Asthma (NCT NCT00869167)
NCT ID: NCT00869167
Last Updated: 2013-05-01
Results Overview
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
TERMINATED
PHASE3
2 participants
baseline and post-treatment (at end of 5 weeks)
2013-05-01
Participant Flow
Participant milestones
| Measure |
Ramelteon
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
Placebo
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ramelteon for Insomnia Comorbid With Asthma
Baseline characteristics by cohort
| Measure |
Ramelteon
n=2 Participants
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
Placebo
n=1 Participants
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
34.5 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
38 years
n=107 Participants
|
35.6 years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and post-treatment (at end of 5 weeks)Population: The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Outcome measures
| Measure |
Ramelteon
n=2 Participants
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
Placebo
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
|
2 units on a scale
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Outcome measures
| Measure |
Ramelteon
n=2 Participants
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
Placebo
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
|---|---|---|
|
Insomnia Severity Index
|
-6.5 units on a scale
Standard Deviation 6.36
|
—
|
SECONDARY outcome
Timeframe: baseline and post-treatment (at end of 5 weeks)Population: The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.
Score of 0-24, with 24 being the most sleepy
Outcome measures
| Measure |
Ramelteon
n=2 Participants
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
Placebo
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
|---|---|---|
|
Daytime Sleepiness (Epworth Sleepiness Scale)
|
3.5 units on a scale
Standard Deviation 0.7
|
—
|
SECONDARY outcome
Timeframe: baseline and post-treatment (at end of 5 weeks)Population: The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.
DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters. DSST score can range from 0-125, with 125 being the most number correct during the allotted time period.
Outcome measures
| Measure |
Ramelteon
n=2 Participants
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
Placebo
Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
|
|---|---|---|
|
Daytime Performance (Digit Symbol Substitution Test)
|
8 Number correct
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: baseline and during treatment period (during 5th week)Population: This measure was added during the study and no subjects completed the measure.
Outcome measures
Outcome data not reported
Adverse Events
Ramelteon
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brandon Lu, M.D., M.S.
California Pacific Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place