Formulation of Fast-Dissolving Sublingual Films of ondansetron Succinate by Electrospinning method and physicochemical and clinical evaluation in eye surgery patients
Formulation of Fast-Dissolving Sublingual Films of ondansetron Succinate by Electrospinning method and physicochemical and clinical evaluation in eye surgery patients
Design
A randomized, double-blind, Control and intervention groups clinical trial
Settings and conduct
In this study, first the ondansetron films were made in Kermanshah School of Pharmacy and then this formulation and marketed form are given to patients in Imam Khomeini Hospital Eye Surgery in Kermanshah. Patients are randomly divided into two groups, and the nurse and patient are blinded to this study as the patients are coded and donot know which medication they were taking.
Participants/Inclusion and exclusion criteria
The age range of patients is between 20 and 50 years. Excluded from the study in case of pregnancy and lactation. Patients should not have systemic diseases such as heart, kidney disease. Patients should not take anti-nausea medications until one day before surgery. Do not have a history of allergy to the drug and its components.
Intervention groups
In this study the efficacy and anti-nausea effect of ondansetron sublingual film is compared with the available forms in the market.
Main outcome variables
Nausea: An unpleasant feeling associated with awareness of the need for vomiting. Retching : Respiratory muscle contraction without gastric contents. Vomiting: Muscle contraction and gastric contents are told.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180120038450N2
Registration date:2019-08-17, 1398/05/26
Registration timing:prospective
Last update:2019-08-17, 1398/05/26
Update count:0
Registration date
2019-08-17, 1398/05/26
Registrant information
Name
Shahla Mirzaeei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3824 0526
Email address
shahlamirzaeei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation of Fast-Dissolving Sublingual Films of ondansetron Succinate by Electrospinning method and physicochemical and clinical evaluation in eye surgery patients
Public title
Evaluation of the Effect of Fast-Dissolving Sublingual Films of ondansetron on the Control of Nausea and Vomiting after Eye Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signature of written consent for participation in the study
Age between 20 and 50 years
From the point of view of classification of physical condition the American Society of Anesthesiologists was in the 1st and 2nd position
Exclusion criteria:
Pregnancy, breastfeeding
Taking drugs with anti-nausea effect in 24 hours before surgery
History of motion sickness
The history of systemic diseases: heart, kidney, liver, lung, psychosis, diabetes
Nausea and vomiting within 24 hours before of eye surgery
Use of steroids 24 hours before surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple and the unit is individual. The random number table is used as a randomization tool. Creating a random sequence is based on a single sequence of random assignments. The encryption is also done using a random-coded encoded box.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, both participants and evaluators of the outcome were unaware of the allocation of study groups. That is, the drugs in each group are similar in appearance.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences and Health Services
Street address
Shahid Beheshti Blvd.- Central Organization of Kermanshah University of Medical Sciences
City
kermanshah
Province
Kermanshah
Postal code
6714858743
Approval date
2019-04-23, 1398/02/03
Ethics committee reference number
IR.KUMS.REC.1398.109
Health conditions studied
1
Description of health condition studied
Patients candidate for eye surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of nausea and vomiting
Timepoint
Baseline (immediately after surgery and before drug administration) and 1, 2, 4, 6 hours after drug administration
Method of measurement
Questionnaire with visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, we use ondansetron, which is made as a sublingual film with polyvinyl alcohol and beta-cyclodextrin polymers. Films containing 4 mg ondansetron are given sublingually only once after surgery if nausea and vomiting occur.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group are given ondansetron sublingual tablets at a dose of 4 mg only once in case of nausea. The patient places the drug under his tongue. This form of medicine is produced by Pars Darou Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Farid daneshgar
Street address
Islamic Republic Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Fax
+98 83 3722 4516
Email
ihosp@kums.ac.ir
Web page address
https://imamkhomaini.kums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
mirzaeei
Street address
Kermanshah University of medical sciences, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
daftarriasat@kums.ac.ir
Web page address
https://www.kums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahla Mirzaeei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
14, 11 Abkaei,Bargh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3824 0526
Fax
Email
shahlamirzaeei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahla Mirzaeei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
14, 11 Abkaei,Bargh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3824 0526
Fax
Email
shahlamirzaeei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahla Mirzaeei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
14, 11 Abkaei,Bargh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3824 0526
Fax
Email
shahlamirzaeei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available