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Clinical trial of hybrid thermosensitive hydrogel based on hyaluronic acid containing celecoxib for knee osteoarthritis patients

Protocol summary

Study aim
The aim of this study is to develop a new group of temperature-sensitive hydrogels for intra-articular injection that show very stable and excellent drug release.
Design
A randomized clinical trial, with two intervention groups, phase 1, single-blind, sample size 84 people, blinding using sealed envelopes, randomization method using permuted block randomization
Settings and conduct
The samples will be selected from patients with mild to moderate arthritis in Shahid Kamyab Hospital and Seyedi Clinic in Mashhad. At this stage, first, the patient's medical history is taken to enter the demographic information of the person and to check the signs of entering and exiting the study, as well as the signs and symptoms related to the disease. If the person meets the criteria for entering the study and does not meet the criteria for exit, the final approval is based on the relevant expert's diagnosis.
Participants/Inclusion and exclusion criteria
Age 45 to 80 years, primary one-side knee osteoarthritis that has been symptomatic (painful) for at least six months.
Intervention groups
Patients with primary OA of the knee are randomly subjected to the injection of temperature-dependent hydrogel containing celecoxib or commercial Hyalgan gel.
Main outcome variables
The detailed range of motion and the sit-and-stand test (at three time points, months 2, 4 and 6) Evaluation of parameters related to the immune system IL-10, TNF-a, IL- 6, TGF-beta1 and ALT and AST and BUN and creatinine will be performed.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221101056363N1
Registration date: 2022-11-22, 1401/09/01
Registration timing: prospective

Last update: 2022-11-22, 1401/09/01
Update count: 0
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
Mona Alibolandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1535
Email address
alibolandim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of hybrid thermosensitive hydrogel based on hyaluronic acid containing celecoxib for knee osteoarthritis patients
Public title
The effect of injectable and sustained-release pharmaceutical form of celecoxib in the treatment of knee osteoarthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary one-sided osteoarthritis of the knee that has been at least 6 months since it became symptomatic (painful) and aggravated by weight bearing and has not responded properly to conservative treatment. Radiographic arthrosis stage 1, 2 and 3 of Kellgren Lawrence classification (KLS) Signing the consent form and complete and voluntary willingness to participate in the study
Exclusion criteria:
Any history of trauma (fracture), surgery and tumor in the knee and lower limb of the same side Clinically obvious alignment disorder Any history of invasive procedure, injection or infection in the desired knee during the last 6 months Any blood disorder History or history of autoimmune disease or being treated with immunosuppressors and non-removable corticosteroids Patients with secondary osteoarthritis Proven liver and kidney disorders Irrevocable consumption of oral or topical painkillers Cognitive impairments and the inability to walk without a walker or the help of others CVA and similar problemsInsulin-dependent diabetic patients Patients with spine disorders and radicular pain to the lower limbs
Age
From 45 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization method is the “permuted block randomization” method. with the following steps: 1- First, we fill the paper for the two treatments A and B with the number of sample size (84 patients) So that we assign 42 patients to A and another 42 patients to B. 2- We put the papers into the lottery bottle and mix thoroughly. We place each one randomly in an envelope. 3- Then patients will be randomly assigned to A and B groups through sealed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakyl Abad Boulevard, Mashhad University of Medical Sciences, School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Approval date
2022-08-13, 1401/05/22
Ethics committee reference number
IR.MUMS.REC.1401.185

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
Evaluation of the parameters related to the immune system including the level of IL-10, TNF-a, IL-6, TGF-beta1)
Timepoint
It will be performed at the beginning, second week and fourth weeks.
Method of measurement
Commercial lab kits

2

Description
liver tests including the serum level of ALT and AST
Timepoint
It will be performed at the beginning, second week and fourth weeks.
Method of measurement
Commercial kits

3

Description
BUN and creatinine
Timepoint
It will be performed at the beginning, second week and fourth weeks.
Method of measurement
Commercial kits

4

Description
Range of motion of the joint (goniometer and degree)
Timepoint
It will be performed at the beginning, second week and fourth weeks.
Method of measurement
goniometer and degree

5

Description
The sitting and standing test (number)
Timepoint
It will be performed at the beginning, second week and fourth weeks.
Method of measurement
Physical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with primary OA of the knee, who after checking the entry and exit criteria and signing the consent form, were randomly injected with temperature-dependent hydrogel containing celecoxib.The surgeon will repeat the injection at week 0, 2 and 4, 2 cc each time for each patient (6 cc in total).
Category
Treatment - Drugs

2

Description
Control group: Patients with primary OA of the knee, who after checking the entry and exit criteria and signing the consent form, were randomly injected with Hyalgan gel. The surgeon will repeat the injection at week 0, 2 and 4, 2 cc each time for each patient (6 cc in total).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamyab and Seyed Hospitals
Full name of responsible person
Mona Alibolandi
Street address
Vakyl Abad Boulevard, Pardis complex, Pharmacy School
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 912 317 6810
Email
alibolandim@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mona Alibolandi
Street address
Vakyl Abad Boulevard, Pardis Complex, School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 912 317 6810
Email
alibolandim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mona Alibolandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil Abad Boulevard, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
009851 3801205
Email
alibolandim@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mona Alibolandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil Abad Boulevard, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
009851 3801205
Email
alibolandim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mona Alibolandi
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakyl Abad Boulevard, Ferdowsi University, Pharmacy School
City
Mashhad
Province
Razavi Khorasan
Postal code
91775365
Phone
+98 51 3180 1535
Fax
Email
alibolandim@mums.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 including range of motion tests and blood tests will be shared.
When the data will become available and for how long
The access starts 2 months after the publication of the article and the patent.برای
To whom data/document is available
All academic and scientific researchers as well as industry are allowed access.
Under which criteria data/document could be used
All the analyzes will be done by us and will be provided to the researchers just to clarify the data.
From where data/document is obtainable
Refer to the person in charge of the project and Mashhad University of Medical Sciences.
What processes are involved for a request to access data/document
An email will be sent to the university and the project manager.
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