Diphenhydramine Ointment for Knee Osteoarthritis

• Sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05036174
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Diphenhydramine 5%; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Diphenhydramine 5% Ointment for Pain in Knee Osteoarthritis: a Randomised Double-blind Placebo-controlled Pilot Feasibility Study
• Anticipated Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diphenhydramine Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days	Drug: Diphenhydramine 5%; Diphenhydramine 5% ointment
Placebo Comparator: Placebo Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days	Drug: Placebo; Placebo matched to diphenhydramine 5% ointment

Outcome Measures

Primary Outcome Measures

1. Recruitment rates [through study completion, an average of 1 year]

   Ability to recruit 8 patients per month

Secondary Outcome Measures

1. Refusal rate [through study completion, an average of 1 year]

   Number of eligible patients who refuse to participate

2. Adherence [through study completion, an average of 1 year]

   Number of patients adhering to 80% of allocated treatment

3. Visual Analogue Scale for Pain [Baseline to week 1]

   The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.

4. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain [Baseline to week 1]

   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..

5. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms [Baseline to week 1]

   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.

6. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL) [Baseline to week 1]

   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.

7. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of function in sports and recreation (Sport/Rec) [Baseline to week 1]

   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.

8. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL) [Baseline to week 1]

   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.

9. Visual Analogue Scale for patient global assessment [Baseline to week 1]

   The Visual Analogue Scale for patient global assessment varies from 0 to 10 cm. Higher values represent worse outcomes.

10. Global evaluation of treatment by patient [Baseline to week 1]

    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.

11. Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain [Week 1]

    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

12. Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment [Week 1]

    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

13. Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living [Week 1]

    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

14. Adverse events [Baseline to Week 1]

    Any adverse event occurred during the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Clinical Immunopharmacology	Novosibirsk		Russian Federation	630047

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ivan Shirinsky, MD, PhD, Head of the laboratory of immunopharmacology, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
• ClinicalTrials.gov Identifier: NCT05036174
• Other Study ID Numbers: 415-5.13.04.2021-1
• First Posted: Sep 5, 2021
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ivan Shirinsky, MD, PhD, Head of the laboratory of immunopharmacology, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology: osteoarthritis; knee; pain; antihistamines
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Diphenhydramine; Promethazine

Study Results

No Results Posted as of Sep 5, 2021