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.
Be male or non-pregnant, non-lactating female subjects, aged 18 to 75 years, inclusive.
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.
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).
Males must be willing to use reliable contraception, as must their partner.
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