Diphenhydramine Ointment for Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Diphenhydramine 5% Ointment for Pain in Knee Osteoarthritis: a Randomised Double-blind Placebo-controlled Pilot Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05036174
• Other study ID #: 415-5.13.04.2021-1
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

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