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

Grünenthal

Status and phase

Completed

Phase 2

Conditions

Chronic Low Back Pain

Treatments

Drug: EN3324 (axomadol)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01043263

EN3324-201

Details and patient eligibility

About

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

Full description

A phase IIB, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

Enrollment

236 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)