Clinical trial to compare the effectiveness of nanoemulsion and commercial formulations of ibuprofen
Design
This study is designed to evaluate the efficacy and short-term safety of topical use of 5% Ibuprofen-nanoemulsion and 5% commercial gel in 124 patients with knee osteoarthritis. This is a Phase III, randomized, double-blind, parallel-group, two-arm, 4-week study. Excel software rand function is used for randomization.
Settings and conduct
It will be performed in the clinic of the orthopedic center of Shafaiehian Hospital. Commercial ibuprofen gel will be included in similar packages of nanoemulsion gel containing ibuprofen. The randomized code will be written on the medicine package. The patient, researcher, physician, and data analyst are unaware of the type of drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The diagnosis of knee osteoarthritis via clinical and radiological examinations, Having mild to moderate knee osteoarthritis, Written informed consent.
Non inclusion criteria: Severe knee pain, history of disease-related surgery such as joint replacement and repair, inflammatory atropathy, metabolic bone disease, knee fracture, history of open wound in the affected knee.
Intervention groups
Intervention group 1: Treatment group with 5% ibuprofen-nanoemulsion gel. Intervention group 2: 5% commercial ibuprofen gel.
For 4 weeks, patients are recommended to use their prescribed drug three times per day as a fingertip unit.
Main outcome variables
Pain; Skin irritation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150902023864N3
Registration date:2021-02-28, 1399/12/10
Registration timing:registered_while_recruiting
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
Amir Amani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 218899111824
Email address
aamani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of 5% ibuprofen nanoemulsion gel and commercial ibuprofen gel on knee osteoarthritis pain
Public title
Effect of Ibuprofen Nanoemulsion Gel on Knee Osteoporosis pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral or bilateral knee osteoarthritis with radiographic evidence according to American College of Rheumatology criteria and the International Osteoarthritis Research Society which is diagnosed through physical examination by the physician
Having mild to moderate knee osteoarthritis pain
Written informed consent to participate in the study
Exclusion criteria:
Very severe knee pain
Recent lower limb injury or surgery such as repair and joint replacement
Inflammatory arthritis
Metabolic bone disease
Fracture and/or dislocation of knee
History of an open wound in the affected knee
History of adverse reactions to NSAIDs
Diabetes and Lupus disease
Corticosteroid injection into the knee within 30 days of intervention
Multiple sclerosis (MS)
The dermatologic disorder which affected the surrounding skin of the knees
Uncontrolled heart failure
High blood pressure
Chronic renal failure
Respiratory diseases
Cancer
History of alcohol or drug abuse
History of neurological disorders affecting sensory, motor or cognitive function
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
124
More than 1 sample in each individual
Number of samples in each individual:
2
Both knees with osteoarthritis are considered as two examples
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by means of a computer randomization system based on fragmented, balanced randomization. In this method to increase the probability of equal numbers of people in both groups, blocks in the form of: AABB-ABAB-ABBA-BBAA-BABA-BAAB are defined as A containing commercial ibuprofen gel and B nanoemulsion gel containing ibuprofen.From 0 to 5 randomizations will be done using digitally randomized codes.
The sequence is constructed in such a way that, with 31 sample volumes, 124 (4⨉31 ) codes will be selected for participants using Excel.
Group A: Commercial ibuprofen gel, Group B: Ibuprofen nanoemulsion gel
Block sizes: 4
Actual list length: 124
In order to concealment the randomization, the container containing the formulation will be the same in terms of shape, only a code will be written on each package so that the prescriber or the patient will be completely unaware of the contents of the container.
Blinding (investigator's opinion)
Double blinded
Blinding description
Commercial ibuprofen gel will be included in similar packages of nanoemulsion gel containing ibuprofen. The randomized code will be written on the medicine package. However, due to the difference in the smell of these two drugs, we try to prevent patients from being able to compare drugs by conducting separate patient interviews. Based on the random number written on the prescription of the patient, pharmacy officials are asked to deliver the medicine to the patients. The researcher will not know which patient was taking which medication. Also, the treating physician will not be aware of the patient's medication. The patient is requested to deliver the used medicine container to the hospital pharmacy at the next visit and to receive the same number from the pharmacy at the next visit. During the second visit of patients, empty containers of medicines will be collected from the pharmacy every day and stored in a special comedy. The statistical data analyzer will not be able to distinguish between the information obtained from the patients of both groups and the information will be completely blinded to their service.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.TUMS.TIPS.REC.1399.118
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain score based on visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index questionnaire
Timepoint
Patients are assessed prior to enrollment and, then, 2 and 4 weeks subsequent to the intervention for knee pain.
Method of measurement
Visual analogue scale on a 10 cm scale and Western Ontario and McMaster Universities Osteoarthritis Index questionnaire
Secondary outcomes
1
Description
skin irritation
Timepoint
24-48 hours in initial use, then two-and four-week visits.
Method of measurement
Questions are asked by phone during the first 24-48 hours, so any skin problems are requested and checked by the doctor during each visit.
Intervention groups
1
Description
Intervention group 1: Nanoemulsion gel containing 5% ibuprofen; Patients are treated with this formulation for 4 weeks and three times a day in the size of a fingertip (equivalent to 100 mg), which has already been prepared and animal studies have been performed.
Category
Treatment - Drugs
2
Description
Intervention group 2: commercial ibuprofen 5% gel; Patients are treated with a commercial gel available in the pharmacy in the size of a fingertip three times a day, for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian hospital
Full name of responsible person
Amir Amani
Street address
Mojahedin-e-Islam street, Baharestan square
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3848 7000
Fax
+98 21 3354 2020
Email
fesmaeili2010@gmail.com
Web page address
https://shafa.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Qods street; Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
amani76@gmail.com
Web page address
https://www.tums.ac.ir/
Grant name
8 articles Grant
Grant code / Reference number
99-2-229-47907
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fariba Esmaeili
Position
post doc
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Fax
+98 21 8899 1117
Email
fesmaeili2010@gmail.com
Web page address
https://satim.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Esmaeili
Position
post doc
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Fax
+98 21 8899 1117
Email
fesmaeili2010@gmail.com
Web page address
https://satim.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Esmaeili
Position
post doc
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Fax
+98 21 8899 1117
Email
fesmaeili2010@gmail.com
Web page address
https://satim.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data potentially can be shared after making participants unidentifiable
When the data will become available and for how long
Nearly in a year
To whom data/document is available
All people
Under which criteria data/document could be used
There is no condition
From where data/document is obtainable
They can email to the researcher
What processes are involved for a request to access data/document