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SLCTR Registration Number
SLCTR/2016/001
Date of Registration
The date of last modification
Jan 27, 2016
View original TRDS
Scientific Title of Trial
A study to determine the palatability of different dosage forms of oral N-Acetylcysteine and methionine among healthy volunteers
Public Title of Trial
A study to determine the palatability of different dosage forms of oral N-Acetylcysteine and methionine among healthy volunteers
Disease or Health Condition(s) Studied
Palatability of antidotes to paracetamol poisoning
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC Peradeniya 2014/EC/95
What is the research question being addressed?
What is the difference in palatability of different dosage forms of N-acetylcysteine and methionine among healthy volunteers?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Crossover
Purpose
Treatment
Study Phase
Intervention(s) planned
The study will be carried out at the South Asian Toxicology Research collaboration, Faculty of Medicine, University of Peradeniya. Undergraduates of the University of Peradeniya who are not enrolled in the medical faculty (i.e. non-medical students) will be invited to participate. Each participant will be randomized to follow the identified sequences in receiving each intervention.
Interventions
1. Single therapeutic dose of oral Nā acetylcysteine (NAC) tablets (70mg/kg *50kg = 3500mg)
2. Single therapeutic dose of oral Nā acetylcysteine (NAC) capsules (70mg/kg *50kg = 3500mg)
3. Single therapeutic dose of oral methionine tablets (2500mg)
4. Single therapeutic dose of oral methionine capsules (2500mg)
5. Single dose of folic acid (400 mcg)
Each participant will receive each of the five interventions in the sequence determined at randomization. A washout period of 1 week take place between each intervention.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Each of the following outcomes will be scored on a modified 100 mm visual analogue scale. |
[ Just after the administration up to one hour ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
60
Countries of recruitment
Sri Lanka
Anticipated start date
2016-01-24
Anticipated end date
2016-03-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
South Asian Clinical Toxicology Research Collaboration
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Prof. Indika Gawarammana
Professor in Medicine
SACTRC, Faculty of Medicine
University of Peradeniya
Peradeniya
0814479822
0714225081
0814479822
indikagaw@gmail.com
Contact Person for Public Queries
Ms. Vindya Pathiraja
Postgraduate Researcher
SACTRC, Faculty of Medicine
University of Peradeniya
Peradeniya
0814479822
0713774520
0814479822
vindyamytime@gmail.com
Primary study sponsor/organization
South Asian Clinical Toxicology Research Collaboration
None
SACTRC, Faculty of Medicine
University of Peradeniya
0814479822
0814479822
enquiry@sactrc.org
www.sactrc.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
