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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: EN3324 (axomadol)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EN3324 (axomadol)<br> | Drug: EN3324 (axomadol)<br>* twice daily dosing<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* twice daily dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 
| 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] |