OsteoarthritisNCT05036174
Diphenhydramine Ointment for Knee Osteoarthritis
A study testing Diphenhydramine 5% in people with Osteoarthritis, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diphenhydramine 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Osteoarthritis
- Being tested
- Diphenhydramine 5%, Placebo
- Keywords
- osteoarthritis, knee, pain, antihistamines
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphenhydramine 5%Drug
Diphenhydramine 5% ointment
PlaceboDrug
Placebo matched to diphenhydramine 5% ointment
| Study group | Role | What they receive |
|---|---|---|
| Diphenhydramine | Experimental | Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days Receives: Drug: Diphenhydramine 5% |
| Placebo | Placebo comparator | Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Ability to recruit 8 patients per month
Measured: through study completion, an average of 1 year
Secondary outcomes (14)
Refusal rate
Number of eligible patients who refuse to participate
Measured: through study completion, an average of 1 year
Adherence
Number of patients adhering to 80% of allocated treatment
Measured: through study completion, an average of 1 year
Visual Analogue Scale for Pain
The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
Measured: Baseline to week 1
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..
Measured: Baseline to week 1
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.
Measured: Baseline to week 1
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.
Measured: Baseline to week 1
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.
Measured: Baseline to week 1
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.
Measured: Baseline to week 1
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.
Measured: Baseline to week 1
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.
Measured: Baseline to week 1
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
Measured: Week 1
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
Measured: Week 1
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
Measured: Week 1
Adverse events
Any adverse event occurred during the study
Measured: Baseline to Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Shirinsky, MD, PhD, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036174
- Sponsor's protocol ID
- 415-5.13.04.2021-1
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diphenhydramine 5% Ointment for Pain in Knee Osteoarthritis: a Randomised Double-blind Placebo-controlled Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05036174
- Acronym / sponsor ID
- 415-5.13.04.2021-1
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee, pain, antihistamines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical ImmunologyUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diphenhydramine | Experimental | Drug: Diphenhydramine 5%Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboVehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphenhydramine 5%Diphenhydramine 5% ointment | Drug | Diphenhydramine |
| PlaceboPlacebo matched to diphenhydramine 5% ointment | Drug | Placebo |
Primary outcome
Recruitment rates
Time frame: through study completion, an average of 1 year
Ability to recruit 8 patients per month
14 secondary outcomes
Refusal rate
Time frame: through study completion, an average of 1 year
Adherence
Time frame: through study completion, an average of 1 year
Visual Analogue Scale for Pain
Time frame: Baseline to week 1
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
Time frame: Baseline to week 1
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
Time frame: Baseline to week 1
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
Time frame: 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
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL)
Time frame: Baseline to week 1
Visual Analogue Scale for patient global assessment
Time frame: Baseline to week 1
Global evaluation of treatment by patient
Time frame: 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 minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment
Time frame: 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
Adverse events
Time frame: Baseline to Week 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Related trials for Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diphenhydramine 5% in people with Osteoarthritis, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Shirinsky, MD, Doctor of Science (+73832282547, ivan.shirinsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.