IDEA-033 Open Label Study

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

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.

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.

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