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IDEA-033 Open Label Study

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00372333
First received: September 4, 2006
Last updated: March 19, 2009
Last verified: March 2009
History of Changes

September 4, 2006
March 19, 2009
August 2004
December 2007   (final data collection date for primary outcome measure)
  • description of AE profile
  • changes in laboratory values
  • IDEA-033 plasma levels
  • visual assessment of skin at target area(s)
  • physical exam
  • vital signs
Same as current
Complete list of historical versions of study NCT00372333 on ClinicalTrials.gov Archive Site
evaluation of efficacy by real time feedback
Same as current
Not Provided
Not Provided
 
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

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Joint Pain
  • Musculoskeletal Pain
  • Stiffness
  • Soft Tissue Inflammation in Designated Target Area(s)
Drug: IDEA-033
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
491
April 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00372333
CL-033-III-01
Not Provided
Not Provided
IDEA AG
Not Provided
Principal Investigator: Ilka Rother X-pert-med GmbH Munich
IDEA AG
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP