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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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by IDEA AG:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • evaluation of efficacy by real time feedback

Enrollment: 491
Study Start Date: August 2004
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00372333     History of Changes
Other Study ID Numbers: CL-033-III-01
Study First Received: September 4, 2006
Last Updated: March 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IDEA AG:
musculoskeletal pain; soft tissue inflammation; IDEA-033

Additional relevant MeSH terms:
Arthralgia
Inflammation
Joint Diseases
Musculoskeletal Diseases
 Pain
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013