se of a Capsaicine 8% plaster for the treatment of low back pai

Phase 1

• Conditions: chronic low back pain with neuropathic pain component or unclear neuropathic pain; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001420-35-AT
• Lead Sponsor: Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects are eligible for the study if all the following apply:
1.Men or women > 18 years.
2.Low back pain of all types with or without irradiation for 3 months or more.
3.Pain intensity: Mean Numerical Rating Scale (NRS) during the 24 h before inclusion > 3/10.
4.Pain Detect Score > 13.
5.No pain treatment at inclusion or stable pain treatment for 1 week prior to inclusion and study day.
6.Intact skin surface at the potential patch application site.
7.Females of child-bearing potential must agree to use effective methods of birth control during the study and for 30 days following study termination.
8.The participant has given written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Subjects are eligible for the study if all the following apply:
1.Men or women > 18 years.
2.Low back pain of all types with or without irradiation for 3 months or more.
3.Pain intensity: Mean Numerical Rating Scale (NRS) during the 24 h before inclusion > 3/10.
4.Pain Detect Score > 13.
5.No pain treatment at inclusion or stable pain treatment for 1 week prior to inclusion and study day.
6.Intact skin surface at the potential patch application site.
7.Females of child-bearing potential must agree to use effective methods of birth control during the study and for 30 days following study termination.
8.The participant has given written informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified