Diphenhydramine Ointment for Knee Osteoarthritis

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
• Treatments: Diphenhydramine; Promethazine

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