Clinical trial NCT05036174: Diphenhydramine Ointment for Knee Osteoarthritis
Official title: Diphenhydramine 5% Ointment for Pain in Knee Osteoarthritis: a Randomised Double-blind Placebo-controlled Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
knee
pain
antihistamines
Lead sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rates
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Refusal rate
timeFrame: through study completion, an average of 1 year
measure: Adherence
timeFrame: through study completion, an average of 1 year
measure: Visual Analogue Scale for Pain
timeFrame: Baseline to week 1
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
timeFrame: Baseline to week 1
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
timeFrame: Baseline to week 1
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
timeFrame: Baseline to week 1
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of function in sports and recreation (Sport/Rec)
timeFrame: Baseline to week 1
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL)
timeFrame: Baseline to week 1
measure: Visual Analogue Scale for patient global assessment
timeFrame: Baseline to week 1
measure: Global evaluation of treatment by patient
timeFrame: Baseline to week 1
measure: Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain
timeFrame: Week 1
measure: Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment
timeFrame: Week 1
measure: Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living
timeFrame: Week 1
measure: Adverse events
timeFrame: Baseline to Week 1
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Laboratory of Clinical Immunopharmacology
Study officials:
References: