Osteoarthritis Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Laboratory of Clinical Immunopharmacology | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rates | Ability to recruit 8 patients per month | through study completion, an average of 1 year | |
Secondary | Refusal rate | Number of eligible patients who refuse to participate | through study completion, an average of 1 year | |
Secondary | Adherence | Number of patients adhering to 80% of allocated treatment | through study completion, an average of 1 year | |
Secondary | Visual Analogue Scale for Pain | The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes. | Baseline to week 1 | |
Secondary | 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.. | Baseline to week 1 | |
Secondary | 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. | Baseline to week 1 | |
Secondary | 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. | Baseline to week 1 | |
Secondary | 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. | Baseline to week 1 | |
Secondary | 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. | Baseline to week 1 | |
Secondary | 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. | Baseline to week 1 | |
Secondary | 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. | Baseline to week 1 | |
Secondary | 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 | Week 1 | |
Secondary | 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 | Week 1 | |
Secondary | 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 |
Week 1 | |
Secondary | Adverse events | Any adverse event occurred during the study | Baseline to Week 1 |
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