Diphenhydramine Ointment for Knee Osteoarthritis

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2022

Interventions

  • Drug: Diphenhydramine 5%
    • Diphenhydramine 5% ointment
  • Drug: Placebo
    • Placebo matched to diphenhydramine 5% ointment

Arms, Groups and Cohorts

  • Experimental: Diphenhydramine
    • Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days
  • Placebo Comparator: Placebo
    • Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days

Clinical Trial Outcome Measures

Primary Measures

  • Recruitment rates
    • Time Frame: through study completion, an average of 1 year
    • Ability to recruit 8 patients per month

Secondary Measures

  • Refusal rate
    • Time Frame: through study completion, an average of 1 year
    • Number of eligible patients who refuse to participate
  • Adherence
    • Time Frame: through study completion, an average of 1 year
    • Number of patients adhering to 80% of allocated treatment
  • Visual Analogue Scale for Pain
    • Time Frame: Baseline to week 1
    • The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
  • Knee injury and Osteoarthritis Outcome Score (KOOS) – subscale Pain
    • Time Frame: 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..
  • Knee injury and Osteoarthritis Outcome Score (KOOS) – subscale Symptoms
    • Time Frame: 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.
  • Knee injury and Osteoarthritis Outcome Score (KOOS) – subscale Activities of daily living (ADL)
    • Time Frame: 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.
  • Knee injury and Osteoarthritis Outcome Score (KOOS) – subscale of function in sports and recreation (Sport/Rec)
    • Time Frame: 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.
  • Knee injury and Osteoarthritis Outcome Score (KOOS) – subscale of quality of life (QOL)
    • Time Frame: 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.
  • Visual Analogue Scale for patient global assessment
    • Time Frame: Baseline to week 1
    • The Visual Analogue Scale for patient global assessment varies from 0 to 10 cm. Higher values represent worse outcomes.
  • Global evaluation of treatment by patient
    • Time Frame: 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.
  • Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain
    • Time Frame: 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
  • Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient’s global assessment
    • Time Frame: 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
  • Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living
    • Time Frame: 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
  • Adverse events
    • Time Frame: Baseline to Week 1
    • Any adverse event occurred during the study

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ivan Shirinsky, MD, PhD, Head of the laboratory of immunopharmacology – Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
  • Overall Contact(s)
    • Ivan Shirinsky, MD, Doctor of Science, +73832282547, ivan.shirinsky@gmail.com

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