Diphenhydramine Ointment for Knee Osteoarthritis
Diphenhydramine 5% Ointment for Pain in Knee Osteoarthritis: a Randomised Double-blind Placebo-controlled Pilot Feasibility Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedSeptember 5, 2021
August 1, 2021
7 months
June 8, 2021
August 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recruitment rates
Ability to recruit 8 patients per month
through study completion, an average of 1 year
Secondary Outcomes (14)
Refusal rate
through study completion, an average of 1 year
Adherence
through study completion, an average of 1 year
Visual Analogue Scale for Pain
Baseline to week 1
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
Baseline to week 1
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
Baseline to week 1
- +9 more secondary outcomes
Study Arms (2)
Diphenhydramine
EXPERIMENTALTopical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days
Placebo
PLACEBO COMPARATORVehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Clinical Immunopharmacology
Novosibirsk, 630047, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the laboratory of immunopharmacology
Study Record Dates
First Submitted
June 8, 2021
First Posted
September 5, 2021
Study Start
September 1, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
September 5, 2021
Record last verified: 2021-08