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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01043263

Acronym

CLBP

Enrollment

236

Registered

2010-01-06

Start date

2009-12-31

Completion date

2011-06-30

Last updated

2015-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Brief 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

Detailed 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

Interventions

DRUGEN3324 (axomadol)

twice daily dosing

DRUGPlacebo

twice daily dosing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.	Change from baseline [Day 0] to final visit [Day 112]

Secondary

Measure	Time frame
To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.	Change from baseline [Day 0] to final visit [Day 112]
To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.	Change from baseline [Day 0] to final visit [Day 112]

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026