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Diphenhydramine Ointment for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Diphenhydramine 5%
Placebo
Sponsored by
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, knee, pain, antihistamines

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Laboratory of Clinical Immunopharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diphenhydramine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recruitment rates
Ability to recruit 8 patients per month

Secondary Outcome Measures

Refusal rate
Number of eligible patients who refuse to participate
Adherence
Number of patients adhering to 80% of allocated treatment
Visual Analogue Scale for Pain
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
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
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)
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)
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)
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
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
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
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
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
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
Any adverse event occurred during the study

Full Information

First Posted
June 8, 2021
Last Updated
August 30, 2021
Sponsor
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT05036174
Brief Title
Diphenhydramine Ointment for Knee Osteoarthritis
Official Title
Diphenhydramine 5% Ointment for Pain in Knee Osteoarthritis: a Randomised Double-blind Placebo-controlled Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, knee, pain, antihistamines

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diphenhydramine
Arm Type
Experimental
Arm Description
Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine 5%
Intervention Description
Diphenhydramine 5% ointment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to diphenhydramine 5% ointment
Primary Outcome Measure Information:
Title
Recruitment rates
Description
Ability to recruit 8 patients per month
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Refusal rate
Description
Number of eligible patients who refuse to participate
Time Frame
through study completion, an average of 1 year
Title
Adherence
Description
Number of patients adhering to 80% of allocated treatment
Time Frame
through study completion, an average of 1 year
Title
Visual Analogue Scale for Pain
Description
The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
Time Frame
Baseline to week 1
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
Description
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..
Time Frame
Baseline to week 1
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
Description
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.
Time Frame
Baseline to week 1
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
Description
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.
Time Frame
Baseline to week 1
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of function in sports and recreation (Sport/Rec)
Description
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.
Time Frame
Baseline to week 1
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL)
Description
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.
Time Frame
Baseline to week 1
Title
Visual Analogue Scale for patient global assessment
Description
The Visual Analogue Scale for patient global assessment varies from 0 to 10 cm. Higher values represent worse outcomes.
Time Frame
Baseline to week 1
Title
Global evaluation of treatment by patient
Description
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.
Time Frame
Baseline to week 1
Title
Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain
Description
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
Time Frame
Week 1
Title
Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment
Description
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
Time Frame
Week 1
Title
Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living
Description
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
Time Frame
Week 1
Title
Adverse events
Description
Any adverse event occurred during the study
Time Frame
Baseline to Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ACR clinical criteria of knee OA Radiographic knee OA (Kellgren-Lawrence grade >1) Age ≥ 50 years VAS pain >= 40/100 mm at baseline Non-use of NSAIDs one week before the baseline Symptoms present on most days for at least 3 months Exclusion Criteria: Any form of inflammatory arthritis Use of another topical product at the application site Treatment with intraarticular hyaluronic acid within 6 months Treatment with intraarticular glucocorticoid within 2 months Knee injury/surgery or diagnostic arthroscopy within 3 months Allergic reaction to diphenhydramine or any component of the formulation 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Shirinsky, MD, Doctor of Science
Phone
+73832282547
Email
ivan.shirinsky@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Valery Shirinsky, Professor, MD
Phone
+73832282547
Email
valery.shirinsky@gmail.com
Facility Information:
Facility Name
Laboratory of Clinical Immunopharmacology
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation

12. IPD Sharing Statement

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Diphenhydramine Ointment for Knee Osteoarthritis

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