Status:
COMPLETED
IDEA-033 Open Label Study
Lead Sponsor:
IDEA AG
Conditions:
Joint Pain
Musculoskeletal Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT00372333
Start Date
August 1 2004
End Date
April 1 2008
Last Update
March 20 2009
Active Locations (1)
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1
X-pert med GmbH / Ilka Rother
Gräfelfing, Bavaria, Germany, 82166