Diphenhydramine Ointment for Knee Osteoarthritis

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

Status: Unknown

Conditions: Osteoarthritis

Treatments: Drug: Placebo; Drug: Diphenhydramine 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT05036174

415-5.13.04.2021-1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Diphenhydramine

Experimental group

Description:

Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days

Treatment:

Drug: Diphenhydramine 5%

Placebo

Placebo Comparator group

Description:

Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days

Treatment:

Drug: Placebo