NCT00372333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

Enrollment Period

3.3 years

First QC Date

September 4, 2006

Last Update Submit

March 19, 2009

Conditions

Joint PainMusculoskeletal PainStiffnessSoft Tissue Inflammation in Designated Target Area(s)

Keywords

musculoskeletal pain; soft tissue inflammation; IDEA-033

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • evaluation of efficacy by real time feedback

Interventions

IDEA-033DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

X-pert med GmbH / Ilka Rother

Gräfelfing, Bavaria, 82166, Germany

Location

MeSH Terms

Conditions

ArthralgiaMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular Diseases

Study Officials

  • Ilka Rother

    X-pert-med GmbH Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2006

First Posted

September 6, 2006

Study Start

August 1, 2004

Primary Completion

December 1, 2007

Study Completion

April 1, 2008

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations

DE(1)