Overview

Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GrĂ¼nenthal GmbH
Criteria
Inclusion Criteria:

- 18 years of age or older

- Are females who are participating abstinence or using a medically acceptable form of
contraception or have been post-menopausal, biologically sterile, or surgically
sterile for more than 1 year.

- Have been on an unchanged regimen of analgesic medication for chronic low back pain on
a daily basis for at least 3 months prior to screening; subjects taking opioids must
not exceed total daily doses of 90mg oral morphine equivalent

- Have a history of moderate to severe CLBP

Exclusion Criteria:

- Have evidence of or a history of alcohol and/or drug abuse

- Have pain secondary to a confirmed or suspected neoplasm

- Intend to alter their physical therapy regimen during the study. Subjects who begin or
end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior
to screening or during the study period will be excluded from the study

- Have a history or physical examination finding, which may confound pain-related data
(e.g., fibromyalgia, radiculopathy)