Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
491 participants
INTERVENTIONAL
2004-08-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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IDEA-033
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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IDEA AG
INDUSTRY
Principal Investigators
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Ilka Rother
Role: PRINCIPAL_INVESTIGATOR
X-pert-med GmbH Munich
Locations
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X-pert med GmbH / Ilka Rother
Gräfelfing, Bavaria, Germany
Countries
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Other Identifiers
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CL-033-III-01
Identifier Type: -
Identifier Source: org_study_id
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