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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05036174
Other study ID # 415-5.13.04.2021-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date April 2022

Study information

Verified date August 2021
Source Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Contact Ivan Shirinsky, MD, Doctor of Science
Phone +73832282547
Email ivan.shirinsky@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate whether recruitment rates are adequate to power a future RCT. The secondary aims are to obtain preliminary information about safety and efficacy of topical diphenhydramine 5% ointment in patients with knee OA.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: 1. ACR clinical criteria of knee OA 2. Radiographic knee OA (Kellgren-Lawrence grade >1) 3. Age = 50 years 4. VAS pain >= 40/100 mm at baseline 5. Non-use of NSAIDs one week before the baseline 6. Symptoms present on most days for at least 3 months Exclusion Criteria: 1. Any form of inflammatory arthritis 2. Use of another topical product at the application site 3. Treatment with intraarticular hyaluronic acid within 6 months 4. Treatment with intraarticular glucocorticoid within 2 months 5. Knee injury/surgery or diagnostic arthroscopy within 3 months 6. Allergic reaction to diphenhydramine or any component of the formulation 7. Participant has clinical signs and symptoms suggestive of COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Diphenhydramine 5%
Diphenhydramine 5% ointment
Placebo
Placebo matched to diphenhydramine 5% ointment

Locations

Country Name City State
Russian Federation Laboratory of Clinical Immunopharmacology Novosibirsk

Sponsors (1)

Lead Sponsor Collaborator
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment rates Ability to recruit 8 patients per month through study completion, an average of 1 year
Secondary Refusal rate Number of eligible patients who refuse to participate through study completion, an average of 1 year
Secondary Adherence Number of patients adhering to 80% of allocated treatment through study completion, an average of 1 year
Secondary Visual Analogue Scale for Pain The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes. Baseline to week 1
Secondary Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain KOOS Pain consists of 9 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.. Baseline to week 1
Secondary Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms KOOS Symptoms consists of 7 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. Baseline to week 1
Secondary Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL) KOOS ADL consists of 17 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. Baseline to week 1
Secondary Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of function in sports and recreation (Sport/Rec) KOOS Sport/Rec consists of 5 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. Baseline to week 1
Secondary Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL) KOOS QOL subscale of quality of life consists of 4 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. Baseline to week 1
Secondary Visual Analogue Scale for patient global assessment The Visual Analogue Scale for patient global assessment varies from 0 to 10 cm. Higher values represent worse outcomes. Baseline to week 1
Secondary Global evaluation of treatment by patient Global evaluation of treatment by patient on 5 point Likert scale. The Global Evaluation of treatment varies from 0 to 5. Higher values represent worse outcomes. Baseline to week 1
Secondary Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain Percentage of patients achieving MCII of VAS pain. The cut-off for MCII changes will be 15 of 100 for absolute improvement and 20% for relative improvement Week 1
Secondary Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment Percentage of patients achieving MCII of VAS patient's global assessment The cut-offs for MCII changes will be 15 of 100 for absolute improvement and 20% for relative improvement for patient's global assessment Week 1
Secondary Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living Percentage of patients achieving MCII of Knee injury and Osteoarthritis Outcome Score (KOOS) subscale of function of daily living.
The cut-offs for MCII changes will be 8 of 100 for absolute improvement for KOOS function in daily living subscale score
Week 1
Secondary Adverse events Any adverse event occurred during the study Baseline to Week 1
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