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

IDEA AG1 site in 1 country491 target enrollmentAugust 2004

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

DrugsIDEA-033

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Joint Pain
Sponsor: IDEA AG
Enrollment: 491
Locations: 1
Primary Endpoint: description of AE profile
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

April 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

IDEA AG

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