IDEA-033 Open Label Study

IDEA AG

Status and phase

Completed

Phase 3

Conditions

Musculoskeletal Pain

Joint Pain

Stiffness

Soft Tissue Inflammation in Designated Target Area(s)

Treatments

Drug: IDEA-033

Study type

Interventional

Funder types

Industry

Identifiers

NCT00372333

CL-033-III-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

491 patients

Sex

All

Ages

18+ years old

Volunteers

No 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