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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Hydrocodone Bitartrate

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 Type: Interventional
• Enrollment (Actual): 424
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85050
      • HOPE Research Institute, LLC
    • Sierra Vista, Arizona, United States, 85635
      • Cochise Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Ortho Research
  • California
    • Bakersfield, California, United States, 93311
      • Pain Institute of California
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Laguna Hills, California, United States, 92653
      • South Orange County Surgical Medical Group
    • San Diego, California, United States, 92128
      • Scripps Clinic, Clinical Research
  • Colorado
    • Golden, Colorado, United States, 80401
      • Mountain View Clinical Research, Inc.
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Jacksonville, Florida, United States, 32257
      • Florida Institute of Medical Research
    • Plantation, Florida, United States, 33317
      • Gold Coast Research, LLC
    • Trinity, Florida, United States, 34655
      • Advanced Research Institute, Inc.
    • Winter Park, Florida, United States, 32789
      • National Pain Research Institute, Inc.
  • Georgia
    • Decatur, Georgia, United States, 30034
      • Best Clinical Research
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research, Inc
  • Idaho
    • Boise, Idaho, United States, 83702
      • Nautical Clinical Research, LLC
  • Illinois
    • Bolingbrook, Illinois, United States, 60490
      • Suburban Clinical Research
  • Kansas
    • Leawood, Kansas, United States, 66211
      • International Clinical Research Institute, Inc.
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology, Inc.
  • Louisiana
    • Mandeville, Louisiana, United States, 70471
      • Clinical Trials Managements, LLC
    • Shreveport, Louisiana, United States, 71101
      • Willis-Knighton Physician Network
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research, Inc.
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Mid-South Anesthesia Consultants
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Health Research
    • Springfield, Missouri, United States, 65807
      • Clinvest
  • Montana
    • Kalispell, Montana, United States, 59901
      • Research West, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources, Inc.
  • New York
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group
    • New York, New York, United States, 10016
      • New York University Pain Management Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Valley Medical Group, PC
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Springfield, Ohio, United States, 45504
      • Hometown Urgent Care and Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73119
      • Hillcrest Clinical Research, Inc.
    • Oklahoma City, Oklahoma, United States, 73134
      • Memorial Clinical Research DBA Angelique Barreto, MD
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Blair Medical Associates
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide, LLC
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • New England Center for Clinical Research, Inc.
  • Texas
    • Dallas, Texas, United States, 75235
      • Renaissance Clinical Research and Hypertension Clinic
    • Fort Worth, Texas, United States, 76104
      • The Clinical Research Center, LLC
    • Houston, Texas, United States, 77008
      • Heights Doctors Clinic
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • San Antonio, Texas, United States, 78209
      • Quality Research, Inc.
  • Utah
    • Clinton, Utah, United States, 84015
      • West Side Medical
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Advanced Pain Management
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocodone Bitartrate; Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.	Drug: Hydrocodone Bitartrate; Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks; Other Names: Hydrocodone Bitartrate Controlled Release (HC-CR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Average Daily Pain	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zogenix, Inc.
• Investigators: Study Director: Vickie Gorgone, Zogenix, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Hydrocodone
• Other Study ID Numbers: ZX002-0802