IDEA-033 Open Label Study

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372333
• Other study ID #: CL-033-III-01
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2006
• Last updated: March 19, 2009
• Start date: August 2004
• Est. completion date: April 2008

Study information

• Verified date: March 2009
• Source: IDEA AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• IDEA-033

Locations

Country	Name	City	State
Germany	X-pert med GmbH / Ilka Rother	Gräfelfing	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
IDEA AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	description of AE profile
Primary	changes in laboratory values
Primary	IDEA-033 plasma levels
Primary	visual assessment of skin at target area(s)
Primary	physical exam
Primary	vital signs
Secondary	evaluation of efficacy by real time feedback