Back to resultsIDEA-033 Open Label Study
Primary Purpose
Joint Pain, Musculoskeletal Pain, Stiffness
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
IDEA-033
Sponsored by
About this trial
This is an interventional treatment trial for Joint Pain focused on measuring musculoskeletal pain; soft tissue inflammation; IDEA-033
Eligibility 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
Sites / Locations
- X-pert med GmbH / Ilka Rother
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372333
Brief Title
IDEA-033 Open Label Study
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IDEA AG
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Pain, Musculoskeletal Pain, Stiffness, Soft Tissue Inflammation in Designated Target Area(s)
Keywords
musculoskeletal pain; soft tissue inflammation; IDEA-033
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
491 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IDEA-033
Primary Outcome Measure Information:
Title
description of AE profile
Title
changes in laboratory values
Title
IDEA-033 plasma levels
Title
visual assessment of skin at target area(s)
Title
physical exam
Title
vital signs
Secondary Outcome Measure Information:
Title
evaluation of efficacy by real time feedback
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilka Rother
Organizational Affiliation
X-pert-med GmbH Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
X-pert med GmbH / Ilka Rother
City
Gräfelfing
State/Province
Bavaria
ZIP/Postal Code
82166
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
IDEA-033 Open Label Study
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