A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain

ZX002-0802

This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

2010-05-01

2012-01-01

2012-01-01

Completed

Early phase I

424

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 424, 'type': 'ACTUAL'}}

2022-11-09