Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02367820
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-nursing female aged 18 to 75 years old
* Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months
* Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
* Opioid analgesia is necessary
* Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry
* Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
* Willing and able to provide informed consent
Exclusion Criteria:
* History of hypersensitivity, intolerance, or allergy to opioids
* Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period
* Untreated moderate to severe sleep apnea
* Chronic migraines as the primary pain condition
* Cancer related pain
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02367820
Study Brief:
Protocol Section:
NCT02367820