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
  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
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, see Learn About Clinical Studies.

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
Musculoskeletal Pain
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Pathologic Processes
Muscular Diseases
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014