Diphenhydramine Ointment for Knee Osteoarthritis

August 30, 2021 updated by: Ivan Shirinsky, MD, PhD, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630047
        • Laboratory of Clinical Immunopharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rates
Time Frame: through study completion, an average of 1 year
Ability to recruit 8 patients per month
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Refusal rate
Time Frame: through study completion, an average of 1 year
Number of eligible patients who refuse to participate
through study completion, an average of 1 year
Adherence
Time Frame: through study completion, an average of 1 year
Number of patients adhering to 80% of allocated treatment
through study completion, an average of 1 year
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.
Baseline to week 1
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..
Baseline to week 1
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.
Baseline to week 1
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.
Baseline to week 1
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.
Baseline to week 1
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.
Baseline to week 1
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.
Baseline to week 1
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.
Baseline to week 1
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
Week 1
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
Week 1
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
Week 1
Adverse events
Time Frame: Baseline to Week 1
Any adverse event occurred during the study
Baseline to Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 415-5.13.04.2021-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings