IDEA-033 Open Label Study (NCT00372333) | Clinical Trial Compass
CompletedPhase 3
IDEA-033 Open Label Study
Germany491 participantsStarted 2004-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.