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

Phase 3

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Hydrocodone Bitartrate

• Registration Number: NCT01115569
• Lead Sponsor: Zogenix, Inc.

Brief Summary

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.

Detailed Description

Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Study Timeline

• Study First Submitted: 2010-04-30
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Disposition First Submitted: 2012-07-18
• Disposition First Submitted QC: 2012-08-06
• Disposition First Posted: 2012-08-15
• Results First Submitted: 2014-02-04
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-25
• Results First Posted: 2014-04-25
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrocodone Bitartrate	Hydrocodone Bitartrate	Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.

Primary Outcome Measures

Name	Time	Method
Mean Change in Average Daily Pain	1 year	Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.

Secondary Outcome Measures

Name	Time	Method
Maintenance of Efficacy	1 year	Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication

Trial Locations

Locations (50)

Stamford Therapeutics Consortium; 🇺🇸 Stamford, Connecticut, United States

Pain Institute of California; 🇺🇸 Bakersfield, California, United States

Georgia Institute for Clinical Research, LLC; 🇺🇸 Marietta, Georgia, United States

New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC; 🇺🇸 Fall River, Massachusetts, United States

CRI Worldwide, LLC; 🇺🇸 Philadelphia, Pennsylvania, United States

Research West, LLC; 🇺🇸 Kalispell, Montana, United States

Heights Doctors Clinic; 🇺🇸 Houston, Texas, United States

Renaissance Clinical Research and Hypertension Clinic; 🇺🇸 Dallas, Texas, United States

Scripps Clinic, Clinical Research; 🇺🇸 San Diego, California, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

HOPE Research Institute, LLC; 🇺🇸 Phoenix, Arizona, United States

Hillcrest Clinical Research, Inc.; 🇺🇸 Oklahoma City, Oklahoma, United States

Memorial Clinical Research DBA Angelique Barreto, MD; 🇺🇸 Oklahoma City, Oklahoma, United States

Cochise Clinical Research; 🇺🇸 Sierra Vista, Arizona, United States

Ortho Research; 🇺🇸 Little Rock, Arkansas, United States

Providence Clinical Research; 🇺🇸 Burbank, California, United States

South Orange County Surgical Medical Group; 🇺🇸 Laguna Hills, California, United States

Mountain View Clinical Research, Inc.; 🇺🇸 Golden, Colorado, 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

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

Infinity Medical Research, Inc.; 🇺🇸 North Dartmouth, Massachusetts, United States

Mid-South Anesthesia Consultants; 🇺🇸 Southaven, Mississippi, United States

Mercy Health Research; 🇺🇸 Saint Louis, Missouri, United States

Clinvest; 🇺🇸 Springfield, Missouri, United States

Lovelace Scientific Resources, Inc.; 🇺🇸 Albuquerque, New Mexico, United States

Long Island Gastrointestinal Research Group; 🇺🇸 Great Neck, New York, United States

New York University Pain Management Center; 🇺🇸 New York, New York, United States

The Center for Clinical Research, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

Valley Medical Group, PC; 🇺🇸 Centerville, Ohio, United States

Prestige Clinical Research; 🇺🇸 Franklin, Ohio, United States

Hometown Urgent Care and Research; 🇺🇸 Springfield, Ohio, United States

Blair Medical Associates; 🇺🇸 Altoona, Pennsylvania, United States

New England Center for Clinical Research, Inc.; 🇺🇸 Cranston, Rhode Island, United States

The Clinical Research Center, LLC; 🇺🇸 Fort Worth, Texas, United States

Clinical Trial Network; 🇺🇸 Houston, Texas, United States

Quality Research, Inc.; 🇺🇸 San Antonio, Texas, United States

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States

Advanced Pain Management; 🇺🇸 Virginia Beach, Virginia, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Best Clinical Research; 🇺🇸 Decatur, Georgia, United States

Florida Institute of Medical Research; 🇺🇸 Jacksonville, Florida, United States

Willis-Knighton Physician Network; 🇺🇸 Shreveport, Louisiana, United States

West Side Medical; 🇺🇸 Clinton, Utah, United States