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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT01115569
First received: April 30, 2010
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: Hydrocodone Bitartrate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • Evaluation of long-term safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Adverse events, withdrawals, physical examination, vital signs, clinical laboratories


Secondary Outcome Measures:
  • Maintenance of Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication


Enrollment: 424
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Hydrocodone Bitartrate Controlled Release (HC-CR)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115569

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

No publications provided

Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01115569     History of Changes
Other Study ID Numbers: ZX002-0802
Study First Received: April 30, 2010
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:
chronic pain

Additional relevant MeSH terms:
Hydrocodone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 14, 2014