NCT00372333CompletedPhase 3
A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation
IDEA AG2 sites in 1 country491 target enrollmentStarted: August 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 491
- Locations
- 2
- Primary Endpoint
- description of AE profile
Study Overview
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 participation.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
description of AE profile
changes in laboratory values
IDEA-033 plasma levels
visual assessment of skin at target area(s)
physical exam
vital signs
Secondary Outcomes
- evaluation of efficacy by real time feedback
Investigators
Study Sites (2)
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