Trial Outcomes & Findings for Effects of Melatonin on Insomnia Symptoms in Older Adults (NCT NCT00230737)
NCT ID: NCT00230737
Last Updated: 2017-03-08
Results Overview
Pharmacokinetic analysis of maximum melatonin level
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
day 42
Results posted on
2017-03-08
Participant Flow
Participant milestones
| Measure |
A: Low Dose
Melatonin 0.4 mg
|
B: High Dose
Melatonin 4.0 mg
|
C: Control
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
8
|
|
Overall Study
COMPLETED
|
9
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Melatonin on Insomnia Symptoms in Older Adults
Baseline characteristics by cohort
| Measure |
A: Low Dose
n=9 Participants
Melatonin 0.4 mg
|
B: High Dose
n=10 Participants
Melatonin 4.0 mg
|
C: Control
n=8 Participants
Placebo
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
75.7 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
75.1 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
74.6 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 42Pharmacokinetic analysis of maximum melatonin level
Outcome measures
| Measure |
A: Low Dose
n=9 Participants
Melatonin 0.4 mg
|
B: High Dose
n=10 Participants
Melatonin 4.0 mg
|
C: Control
n=8 Participants
Placebo
|
|---|---|---|---|
|
Peak Melatonin Level
|
405 pg/ml
Standard Error 93
|
3999 pg/ml
Standard Error 700
|
52 pg/ml
Standard Error 8.1
|
Adverse Events
A: Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B: High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place