Summary:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of [Investigational Drug] in Subjects with a Recent History of Moderate to Severe Chronic Low Back Pain Currently Treated with
Opioids
Qualified Participants Must:
• Provide written informed consent prior to the conduct of any study-related procedures.
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Be male or non-pregnant, non-lactating female subjects, aged 18 to 75 years, inclusive.
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Have a clinical diagnosis of a recent history of moderate to severe CLBP for a minimum of 3 months prior to Screening. The pain must occur in an area with boundaries between the lowest rib and immediately above the knee with no radiculopathy.
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Female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire study (Screening Visit to final Follow-up Visit) (Section 10.1.5). To be considered not of childbearing potential, female subjects must be surgically sterile (hysterectomy or bilateral oophorectomy, or bilateral tubal ligation with surgery at least 6 weeks before study initiation).
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Males must be willing to use reliable contraception, as must their partner.
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Subject must be willing and able to comply with all study procedures and requirements.
Qualified Participants May Receive:
- Compensation for Time and Travel, If Qualified
- Study-related medication or placebo
- Physical exam by a licensed physician