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IDEA-033 Open Label Study

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ClinicalTrials.gov Identifier: NCT00372333
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : March 20, 2009
Sponsor:
Information provided by:

Study Description
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.

Study Design

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
Primary Completion Date : December 2007
Study Completion Date : April 2008
Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00372333


Locations
Germany
X-pert med GmbH / Ilka Rother
Gräfelfing, Bavaria, Germany, 82166
Sponsors and Collaborators
IDEA AG
Investigators
Principal Investigator: Ilka Rother X-pert-med GmbH Munich
More Information

ClinicalTrials.gov Identifier: NCT00372333     History of Changes
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:
Inflammation
Musculoskeletal Pain
Arthralgia
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Joint Diseases