Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioDelivery Sciences International
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
Stable health, as determined by the Principal Investigator
Subject is willing and able to comply with all protocol required visits and assessments
Rollover subject who has completed the 12-week Double-blind Treatment Phase in the EN3409-307/308 clinical study
You may not be if
A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
Females who are pregnant, breastfeeding, or plan to become pregnant during the study
Current cancer-related pain or received chemotherapy within 6 months of screening
Subjects receiving opioid analgesic medication \< 60 mg MSE per day within 28 days of screening
De novo subjects receiving opioid analgesic medication at doses of \> 160 mg MSE per day within 28 days of screening
Subjects with a history of other chronic painful conditions, other than the index CP condition, which require frequent analgesic medication
