Joint PainPhase 3NCT00372333
IDEA-033 Open Label Study
A Phase 3 study testing IDEA-033 in people with Joint Pain and Musculoskeletal Pain, run by IDEA AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Pain, Musculoskeletal Pain, Stiffness
- What is being tested?
- IDEA-033
- How many people
- 491 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Joint Pain, Musculoskeletal Pain, Stiffness, Soft Tissue Inflammation in Designated Target Area(s)
- Being tested
- IDEA-033
- Keywords
- musculoskeletal pain; soft tissue inflammation; IDEA-033
- Medical subject headings
- Arthralgia, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEA-033Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
evaluation of efficacy by real time feedback
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startAug 2004
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDEA AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ilka Rother, Principal investigator, X-pert-med GmbH Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372333
- Sponsor's protocol ID
- CL-033-III-01
- Status last verified
- Mar 2009
- First submitted
- 4 Sep 2006
- Last updated
- 20 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00372333
- Acronym / sponsor ID
- CL-033-III-01
- Conditions
- Joint Pain, Musculoskeletal Pain, Stiffness, Soft Tissue Inflammation in Designated Target Area(s)
- Keywords
- musculoskeletal pain; soft tissue inflammation; IDEA-033
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- IDEA AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDEA-033 | Drug | – |
Primary outcome
description of AE profile
changes in laboratory values
IDEA-033 plasma levels
visual assessment of skin at target area(s)
physical exam
vital signs
1 secondary outcome
evaluation of efficacy by real time feedback
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilka Rother principal investigator
X-pert-med GmbH Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDEA-033 in people with Joint Pain and Musculoskeletal Pain, run by IDEA AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of AE profile. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2009.