IDEA-033 Open Label Study

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IDEA AG

Criteria

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