IDEA-033 Open Label Study

Study Overview
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Brief Summary
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The main aim of the study is to evaluate safety, efficacy, compliance, and usage of epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.

Detailed Description
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Multi-centre, one arm, multiple dose, open-label, at home usage study. Adult volunteers experiencing joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation will be screened for study participation.

Official Title
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A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation

Conditions
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Joint Pain, Musculoskeletal Pain, Stiffness, Soft Tissue Inflammation in Designated Target Area(s)

Intervention / Treatment
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* Drug: IDEA-033


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years or older agree to refrain from chronic usage of NSAIDs or any other analgesics or anti-inflammatory drugs other than those provided during the course of the study or documented sporadic concomitant analgesics joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation in designated target area(s) that are appropriate for self-treatment with a topical analgesic or where availability of a second person can be guaranteed in case self-treatment is not possible healthy skin in the target area(s) Exclusion Criteria: known hypersensitivity to IDEA-033 or other NSAIDs history of coagulation disorders history of peptic ulcers or gastric intolerance with NSAIDs urinary tract infection clinically significant renal, hepatic, or gastric disease acute or chronic coexisting illness qualifying for exclusion according to clinical judgement of the investigator clinical laboratory values outside normal range deemed clinically significant by the investigator Narcotics-containing products within 7 days of administering IMP Malignancy within the past 2 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IDEA-033|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of AE profile |  |  | 
| changes in laboratory values |  |  | 
| IDEA-033 plasma levels |  |  | 
| visual assessment of skin at target area(s) |  |  | 
| physical exam |  |  | 
| vital signs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of efficacy by real time feedback |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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musculoskeletal pain; soft tissue inflammation; IDEA-033