IDEA-033 Open Label Study

Phase 3

Completed

• Conditions: Joint Pain; Musculoskeletal Pain; Stiffness; Soft Tissue Inflammation in Designated Target Area(s)

• Registration Number: NCT00372333
• Lead Sponsor: IDEA AG

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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2006-09-04
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-06
• Primary Completion: 2007-12
• Study Completion: 2008-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-19
• Last Update Posted: 2009-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
evaluation of efficacy by real time feedback

Trial Locations

Locations (1)

X-pert med GmbH / Ilka Rother; 🇩🇪 Gräfelfing, Bavaria, Germany