IDEA-033 Open Label Study

A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00372333

Enrollment

491

Registered

2006-09-06

Start date

2004-08-31

Completion date

2008-04-30

Last updated

2009-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Pain, Musculoskeletal Pain, Soft Tissue Inflammation in Designated Target Area(s), Stiffness

Keywords

musculoskeletal pain; soft tissue inflammation; IDEA-033

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.

Interventions

DRUGIDEA-033

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
IDEA-033 plasma levels	—
physical exam	—
vital signs	—
visual assessment of skin at target area(s)	—
description of AE profile	—
changes in laboratory values	—

Secondary

Measure	Time frame
evaluation of efficacy by real time feedback	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026