Clinical Trial Results:
Double blind randomised controlled trial of exogenous administration of melatonin in chronic pain (DREAM-CP)
Summary
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EudraCT number |
2018-004048-50 |
Trial protocol |
GB |
Global end of trial date |
11 Sep 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Jan 2025
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First version publication date |
25 Jan 2025
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Other versions |
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Summary report(s) |
DREAM-CP data summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
3-062-18
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Additional study identifiers
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ISRCTN number |
ISRCTN12861060 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University of Aberdeen
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Sponsor organisation address |
Foresterhil, Aberdeen, United Kingdom, AB252ZD
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Public contact |
Professor /Co-investigator, University of Aberdeen, +44 07900603649, h.f.galley@abdn.ac.uk
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Scientific contact |
Professor /Co-investigator, University of Aberdeen, +44 07900603649, h.f.galley@abdn.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Sep 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Mar 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Sep 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Does melatonin treatment improve sleep disturbance in patients with chronic pain?
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Protection of trial subjects |
All staff working on the trial are GCP trained and have a thorough understanding of anticipated adverse events and the reporting process of these events.
The sponsor is notified of any serious adverse event within 24 hours as par protocol.
The Data Monitoring Committee (DMC) are assigned to review overall safety data to identify safety issues which may not be apparent on an individual case basis.
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Background therapy |
Melatonin will be administered as Circadin (2mg tablets, Flynn Pharmaceuticals Ltd.) which has EMA regulatory approval and is a slow release formulation with a blood concentration profile resembling that of endogenous melatonin | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
46
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From 65 to 84 years |
14
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants are recruited from the Pain clinical Aberdeen Royal Infirmary | |||||||||||||||
Pre-assignment
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Screening details |
- | |||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
60 | |||||||||||||||
Number of subjects completed |
60 | |||||||||||||||
Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group A | |||||||||||||||
Arm description |
Received Melatonin first then placebo after washout period | |||||||||||||||
Arm type |
melatonin first | |||||||||||||||
Investigational medicinal product name |
2mg oral Circadin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg Circadin taken 2 hours before planned bedtime
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Arm title
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Group B | |||||||||||||||
Arm description |
Received Placebo first then melatonin after washout period | |||||||||||||||
Arm type |
receive placebo before active drug | |||||||||||||||
Investigational medicinal product name |
2mg oral placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg placebo taken 2 hours before planned bedtime
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Period 2
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Period 2 title |
Period 1
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group A | |||||||||||||||
Arm description |
Received Melatonin first then placebo after washout period | |||||||||||||||
Arm type |
melatonin first | |||||||||||||||
Investigational medicinal product name |
2mg oral Circadin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg Circadin taken 2 hours before planned bedtime
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Arm title
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Group B | |||||||||||||||
Arm description |
Received Placebo first then melatonin after washout period | |||||||||||||||
Arm type |
receive placebo before active drug | |||||||||||||||
Investigational medicinal product name |
2mg oral placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg placebo taken 2 hours before planned bedtime
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Period 3
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Period 3 title |
Washout period
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Blinding implementation details |
DREAM-CP is a crossover randomised trial. The washout out period is the crossover period.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group A | |||||||||||||||
Arm description |
Received Melatonin first then placebo after washout period | |||||||||||||||
Arm type |
melatonin first | |||||||||||||||
Investigational medicinal product name |
2mg oral Circadin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg Circadin taken 2 hours before planned bedtime
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Arm title
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Group B | |||||||||||||||
Arm description |
Received Placebo first then melatonin after washout period | |||||||||||||||
Arm type |
receive placebo before active drug | |||||||||||||||
Investigational medicinal product name |
2mg oral placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg placebo taken 2 hours before planned bedtime
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Period 4
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Period 4 title |
Period 2
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group A | |||||||||||||||
Arm description |
Received Melatonin first then placebo after washout period | |||||||||||||||
Arm type |
melatonin first | |||||||||||||||
Investigational medicinal product name |
2mg oral Circadin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg Circadin taken 2 hours before planned bedtime
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Arm title
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Group B | |||||||||||||||
Arm description |
Received Placebo first then melatonin after washout period | |||||||||||||||
Arm type |
receive placebo before active drug | |||||||||||||||
Investigational medicinal product name |
2mg oral placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg placebo taken 2 hours before planned bedtime
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Baseline characteristics reporting groups
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Reporting group title |
Group A
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Reporting group description |
Received Melatonin first then placebo after washout period | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group B
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Reporting group description |
Received Placebo first then melatonin after washout period | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
DREAM Per Protocol
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
DREAM Per protocol
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Subject analysis set title |
DREAM Intention-to-treat
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
DREAM intention to treat
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End points reporting groups
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Reporting group title |
Group A
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Reporting group description |
Received Melatonin first then placebo after washout period | ||
Reporting group title |
Group B
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Reporting group description |
Received Placebo first then melatonin after washout period | ||
Reporting group title |
Group A
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Reporting group description |
Received Melatonin first then placebo after washout period | ||
Reporting group title |
Group B
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Reporting group description |
Received Placebo first then melatonin after washout period | ||
Reporting group title |
Group A
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Reporting group description |
Received Melatonin first then placebo after washout period | ||
Reporting group title |
Group B
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Reporting group description |
Received Placebo first then melatonin after washout period | ||
Reporting group title |
Group A
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Reporting group description |
Received Melatonin first then placebo after washout period | ||
Reporting group title |
Group B
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Reporting group description |
Received Placebo first then melatonin after washout period | ||
Subject analysis set title |
DREAM Per Protocol
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
DREAM Per protocol
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Subject analysis set title |
DREAM Intention-to-treat
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
DREAM intention to treat
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End point title |
Primary outcome | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The primary outcome measure was VSH sleep disturbance after 6 weeks of treatment.
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Statistical analysis title |
linear mixed model | ||||||||||||
Comparison groups |
Group A v Group B
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
24 Hours
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
No dictionary used | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
n/a
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Reporting groups
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Reporting group title |
Group A
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Reporting group description |
Received Melatonin first then placebo after washout period | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group B
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Reporting group description |
Received Placebo first then melatonin after washout period | |||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/38355388 |