IDEA-033 Open Label Study
IDEA-033 Open Label Study
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