Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

Completed · Phase 3

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT01115569

Run by

Zogenix, Inc.

People needed

424

Starts

2010-05-01

Expected to finish

2012-01-01

Last updated by the study team

2022-11-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• HOPE Research Institute, LLC — Phoenix, Arizona, United States
• Cochise Clinical Research — Sierra Vista, Arizona, United States
• Ortho Research — Little Rock, Arkansas, United States
• Pain Institute of California — Bakersfield, California, United States
• Providence Clinical Research — Burbank, California, United States
• South Orange County Surgical Medical Group — Laguna Hills, California, United States
• Scripps Clinic, Clinical Research — San Diego, California, United States
• Mountain View Clinical Research, Inc. — Golden, Colorado, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Gold Coast Research, LLC — Plantation, Florida, United States
• Advanced Research Institute, Inc. — Trinity, Florida, United States
• National Pain Research Institute, Inc. — Winter Park, Florida, United States
• Best Clinical Research — Decatur, Georgia, United States
• Georgia Institute for Clinical Research, LLC — Marietta, Georgia, United States
• Better Health Clinical Research, Inc — Newnan, Georgia, United States
• Nautical Clinical Research, LLC — Boise, Idaho, United States
• Suburban Clinical Research — Bolingbrook, Illinois, United States
• International Clinical Research Institute, Inc. — Leawood, Kansas, United States
• Clinical Trials Technology, Inc. — Prairie Village, Kansas, United States
• Clinical Trials Managements, LLC — Mandeville, Louisiana, United States
• Willis-Knighton Physician Network — Shreveport, Louisiana, United States
• New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC — Fall River, Massachusetts, United States
• Infinity Medical Research, Inc. — North Dartmouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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