Trial | NCT00372333  Report issue

Title

IDEA-033 Open Label Study
A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    491
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.
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 Started
Aug 31
2004
Primary Completion
Dec 31
2007
Study Completion
Apr 30
2008
Last Update
Mar 20
2009
Estimate

Drug IDEA-033

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
No Results Posted