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:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01115569
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain
* Subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
* Subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months
* Females subjects of childbearing potential must have a negative urine pregnancy test at the Screen Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
* Subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
* Subjects must voluntarily provide written informed consent
Exclusion Criteria:
* Any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain or increase the risk of opioid-related adverse events (AEs)
* A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete study drug
* A surgical procedure for pain within the last 3 months
* Uncontrolled blood pressure, i.e., a sitting systolic blood pressure \>180 mm Hg or \<90 mm Hg, and/or a sitting diastolic blood pressure \>120 mm Hg or \<50 mm Hg at Screening
* A body mass index (BMI) \> 45 kg/m2
* A hospital anxiety and depression scale (HADS) score of \>12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled
* A clinically significant abnormality in clinical chemistry, hematology or urinalysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01115569
Study Brief:
Protocol Section:
NCT01115569