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IDEA-033 Open Label Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372333
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : March 20, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Joint Pain Musculoskeletal Pain Stiffness Soft Tissue Inflammation in Designated Target Area(s) Drug: IDEA-033 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation
Study Start Date : August 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2008

Primary Outcome Measures :
  1. description of AE profile
  2. changes in laboratory values
  3. IDEA-033 plasma levels
  4. visual assessment of skin at target area(s)
  5. physical exam
  6. vital signs

Secondary Outcome Measures :
  1. evaluation of efficacy by real time feedback

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372333

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X-pert med GmbH / Ilka Rother
Gräfelfing, Bavaria, Germany, 82166
Sponsors and Collaborators
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Principal Investigator: Ilka Rother X-pert-med GmbH Munich

Layout table for additonal information Identifier: NCT00372333    
Other Study ID Numbers: CL-033-III-01
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009
Keywords provided by IDEA AG:
musculoskeletal pain; soft tissue inflammation; IDEA-033
Additional relevant MeSH terms:
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Musculoskeletal Pain
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms
Joint Diseases