Clinical trial of a topical emulgel containing piroxicam-entrapped nanoniosomes in patients with osteoarthritis or rheumatoid arthritis complaining joint pain
Clinical trial of emulgel containing piroxicam nanoniosomes to control joint pain in osteoarthritis and rheumatoid arthritis patients
Evaluating the levels of pain before and after topical administration of piroxicam gel available in the market and comparing its effectiveness with emulgel containing piroxicam nanoniosomes
Evaluation of patients' activity, age and gender on the pain experience before and after topical administration of piroxicam in the control and test groups
Design
Clinical trial including parallel control and test groups, double-blinded, randomized by using random numbers table, phase 2-3 on 40 patients
Settings and conduct
This double-blinded trial will be conducted in collaboration with the Anesthesiology Department of Shiraz University of Medical Sciences on patients with rheumatoid arthritis or osteoarthritis who experience pain in one or more joints. All individuals involved in this study except the trial designer will be blinded to the content of the tubes. Blinding was done by repackaging the commercial gel form of piroxicam and packaging to tubes which are completely similar to the niosomal emulgel and assigning a specific code to each tube by the designer.
Participants/Inclusion and exclusion criteria
Including criteria:
Experiencing acute (less than three weeks), Sub-acute (three weeks to three months) or chronic (more than three months) joint pain
Age between 18 to 80 years old
Excluding criteria:
Consumption of oral, rectal, or parenteral pain killers or anti-inflammation drugs
Intervention groups
The control group uses standard topical treatment including the commercial piroxicam 0.5% gel available in the pharmaceutical market of Iran twice a day.
The test group consumes topical piroxicam 0.5% gel and emulgel containing piroxicam nanoniosomes twice a day.
Main outcome variables
Reduction of joint pain in rest and during movement;
General information
Reason for update
Acronym
PNNE
IRCT registration information
IRCT registration number:IRCT20180526039839N1
Registration date:2024-03-16, 1402/12/26
Registration timing:registered_while_recruiting
Last update:2024-03-16, 1402/12/26
Update count:0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
Moein Masjedi
Name of organization / entity
Daroo Sazan Sorena Exir Pharmaceutical Company
Country
Iran (Islamic Republic of)
Phone
+98 71 3634 2081
Email address
masjedi_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-03-17, 1402/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of a topical emulgel containing piroxicam-entrapped nanoniosomes in patients with osteoarthritis or rheumatoid arthritis complaining joint pain
Public title
Evaluation of the palliative effect of a topical emulgel containing piroxicam-entrapped nanoniosomes on patients suffering OA or RA with joint pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Experiencing pain in one or more joint
Having acute (less than three weeks), Sub-acute (three weeks to three months) or chronic (more than three months) joint pain
Age between 18 to 80 years old
Exclusion criteria:
Consumption of oral, rectal, or parenteral pain killers or anti-inflammation drugs including corticosteroids, NSAIDs, acetaminophen, narcotics, Herbal pain killers with scientifically-proven effect
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with simple method using random numbers table with equal samples in each group will be performed. According to the sample size, 40 numbers are required. In doing so, a randomized numbers table consisted of 8 rows and 5 columns will be exploited. The first number will be selected blindly by the trial designer and continue until 20 numbers will be selected (Control group). The remained number will be assigned for treatment (Test) group. Finally, each patient will be located in control or test groups based on the queue of referral.
Blinding (investigator's opinion)
Double blinded
Blinding description
The odd codes will be assigned to the control group and the even codes will be assigned to the treatment group. The designer of the study is aware of the codes assigned to each group. However, the study performers, collaborators, and other healthcare members associated to this clinical trial will remain blind until the end of the trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No.3, Pegah Building, Goldasht 3rd Entrance, Dr. Shariati (Maaliabad Blvd)
City
Shiraz
Province
Fars
Postal code
7188638517
Approval date
2024-01-08, 1402/10/18
Ethics committee reference number
IR.SUMS.REC.1402.458
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
2
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Joint pain in rest and during movement
Timepoint
The pain levels will be recorded daily from the first to the seventh day of initiating the clinical trial
Method of measurement
The pain level will be measured using numerical rating scale.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients receiving topical standard treatment including Razak Pharmaceutical Co. piroxicam 0.5% gel twice daily for one week
Category
Treatment - Drugs
2
Description
Intervention group: Patients receiving piroxicam nanoniosome emulgel and topical standard treatment including Razak Pharmaceutical Co. piroxicam 0.5% gel twice daily for one week