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Trial registered on ANZCTR


Registration number
ACTRN12618000522213
Ethics application status
Approved
Date submitted
21/12/2017
Date registered
9/04/2018
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Melatonin on the Daytime Sleepiness side-effect of Gabapentin in Patients With Neuropathic Pain
Scientific title
Effect of Melatonin on the Daytime Sleepiness side-effect of Gabapentin in Adult Patients With Neuropathic Pain
Secondary ID [1] 293661 0
None
Universal Trial Number (UTN)
U1111-1206-8950
Trial acronym
MGT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic pain 305951 0
drug side effect 305952 0
Sleepiness 305959 0
Condition category
Condition code
Anaesthesiology 305145 305145 0 0
Pain management
Neurological 305685 305685 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients suffering from “neuropathic pain” and planed to receive gabapentin therapy will be included in the study. The patients will be randomly divided into two groups based on a software program; group 1 (melatonin +/receive melatonin) and group 2 (melatonin -/receive placebo). All patients will receive oral gabapentin therapy (Neurontin®, Pfizer, Turkey) as day 1, 300 mg; day 2, 600 mg (300 mg two times per day); day 3, 900 mg (300 mg, three times per day) and 900 mg (300 mg, three times per day) thereafter.
Patients in group 1 (melatonin +) will receive 3 mg melatonin (Melatonina®, Interpharm, Turkey) orally 60 minutes before bedtime starting from the first day of gabapentin therapy While patients in group 2 (placebo) will receive matching placebo capsules 60 min before bedtime. Melatonin therapy will continue for 30 days while gabapentin therapy will last for 3 months. A calendar with two boxes for each study drug under each day, will be given to all of the patients. The patients will be asked to fill in the related boxes if they remember to take their drugs on that day. The calendars will be checked on 10th and 30th days to monitor adherence to the therapy.
Intervention code [1] 299921 0
Treatment: Drugs
Comparator / control treatment
The patients in the control group will receive the same ramp-up oral gabapentin therapy (Neurontin®, Pfizer, Turkey) as day 1, 300 mg; day 2, 600 mg (300 mg two times per day); day 3, 900 mg (300 mg, three times per day) and 900 mg (300 mg, three times per day) thereafter. Starting from the first day of gabapentin therapy, they will receive a microcellulose placebo capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 304300 0
To determine the effect of melatonin on daytime sleepiness caused by gabapentin as assessed by Epworth sleepiness scale (ESS)
Timepoint [1] 304300 0
Baseline, 10th (primary timepoint) and 30th days of treatment
Primary outcome [2] 304301 0
To assess the effect of melatonin on sleep quality assessed by Pittsburgh sleep quality index for assessment of sleep quality (PSQI)
Timepoint [2] 304301 0
Baseline, 10th (primary timepoint) and 30th days of treatment
Secondary outcome [1] 341521 0
To assess the effect of melatonin on neuropathic pain as assessed using a Verbal Rating Scale (VRS)
Timepoint [1] 341521 0
Baseline, 10th and 30th days of treatment
Secondary outcome [2] 341522 0
To determine the drug-related side-effects, we will ask the patients fill in a simple questionnaire (not a validated, specific one) at different timepoints. The questionnaire will include eight different complaints (headache, dizziness, nausea, vomiting, aggression, fatique, drawsiness and paresthesia) and there will be boxes near each of the complaint. We will ask the patients check the related boxes if they have that complaint.
Timepoint [2] 341522 0
Baseline, 10th and 30th day of the treatment

Eligibility
Key inclusion criteria
Patients suffering from “neuropathic pain” and planed to receive gabapentin therapy will be consecutively included in the study
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with sleep apnea syndrome, liver disease, chronic kidney disease, abnormal thyroid hormone levels, anemia, preexisting gabapentin consumption and patients under insomnia therapy will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed by the SPSS System (version 15.0, SPSS Inc., Chicago, IL, USA). Values will be expressed as mean±standard deviation or as percentages. The groups will be compared in parametric parameters using independent samples T-test and in non-parametric parameters using Mann-Whitney U test. The percentage will be calculated in presence and absence group by Pearson's Chi-square test. p< 0.05 will be accepted statistically significant.
Sample size of the study was calculated based on a pilot study with 5 patients in each group. All patients received melatonin or placebo capsules for 10 days and with a 2-sided significance level of .05, power of 0.80, 36 participants were needed per treatment group. Considering drop-out ratio as 10%, 40 participants per group were included in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2018
Actual
23/04/2018
Date of last participant enrolment
Anticipated
11/05/2018
Actual
16/05/2018
Date of last data collection
Anticipated
11/06/2018
Actual
16/06/2018
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 9459 0
Turkey
State/province [1] 9459 0
Ankara

Funding & Sponsors
Funding source category [1] 298277 0
Hospital
Name [1] 298277 0
Hacettepe University Hospital
Country [1] 298277 0
Turkey
Primary sponsor type
Individual
Name
Basak Altiparmak
Address
Work Organisation adress: Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA
Country
Turkey
Secondary sponsor category [1] 297397 0
None
Name [1] 297397 0
Address [1] 297397 0
Country [1] 297397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299281 0
Hacettepe University Clinical Research Ethics Board
Ethics committee address [1] 299281 0
Hacettepe Üniversitesi Rektörlügü Sihhiye/ANKARA, 06100
Ethics committee country [1] 299281 0
Turkey
Date submitted for ethics approval [1] 299281 0
30/06/2009
Approval date [1] 299281 0
06/10/2009
Ethics approval number [1] 299281 0
HEK 09/175-105

Summary
Brief summary
In this study, our primary hypothesis is: “Melatonin may decrease daytime sleepiness, the most frequent adverse effect of gabapentin, and improve the quality of sleep in patients with neuropathic pain”. Our secondary hypothesis is: “Melatonin may help in the attenuation of neuropathic pain of gabapentin and sleep quality in patients with neuropathic pain”.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79894 0
Dr Basak ALTIPARMAK
Address 79894 0
Working organisation address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA.
Country 79894 0
Turkey
Phone 79894 0
+90 532 6726533
Fax 79894 0
Email 79894 0
[email protected]
Contact person for public queries
Name 79895 0
Basak Altiparmak
Address 79895 0
Working organisation address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA.
Country 79895 0
Turkey
Phone 79895 0
+905326726533
Fax 79895 0
Email 79895 0
[email protected]
Contact person for scientific queries
Name 79896 0
Basak Altiparmak
Address 79896 0
Working organisation address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA.
Country 79896 0
Turkey
Phone 79896 0
+905326726533
Fax 79896 0
Email 79896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Between November 2018 (online publication date of the article) and November 2019
Available to whom?
only researchers who provide a methodologically sound proposal,
Available for what types of analyses?
only to achieve the aims in the approved proposal,
How or where can data be obtained?
ccess subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEffect of melatonin on the daytime sleepiness side-effect of gabapentin in adults patients with neuropathic pain2018https://doi.org/10.1016/j.bjane.2018.08.002
Dimensions AIEfeito da melatonina sobre o efeito colateral de sonolência diurna da gabapentina em pacientes adultos com dor neuropática2019https://doi.org/10.1016/j.bjan.2018.08.003
N.B. These documents automatically identified may not have been verified by the study sponsor.