Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT01081912
First received: March 4, 2010
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.


Condition Intervention Phase
Back Pain Lower Back Chronic
Drug: Placebo
Drug: Hydrocodone bitartrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • Mean Change in 24-hour Pain Intensity Ratings Scale (NRS). [ Time Frame: Baseline to Day 85 (Treatment Phase) ] [ Designated as safety issue: No ]
    Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.


Secondary Outcome Measures:
  • Mean Change of the Clinic NRS Pain Intensity [ Time Frame: Baseline to Day 85 visit ] [ Designated as safety issue: No ]
    The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)


Enrollment: 510
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydrocodone Bitartrate Capsules
Hydrocodone Bitartrate Controlled-Release Capsules
Drug: Hydrocodone bitartrate

dosage form: capsule

Strengths 10mg, 20mg, 30mg, 40mg, 50mg

Placebo Comparator: Placebo comparator Drug: Placebo
Capsules, no active substance, shells identical to active comparator capsules
Other Name: Sugar pill

Detailed Description:

A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call

  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 clinical diagnosis of moderate to severe chronic lower back pain (CLBP)
  • Subjects must be classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after lower back pain (LBP) surgery
  • Subjects must in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their chronic lower back pain (CLBP).
  • Subjects must have been taking opioids for at least 5 days/week for the past 4weeks
  • Subjects must have an average Clinic Pain Score of ≥ 4 on the 11-point (0-10) numeric rating scale (NRS) as an average for the last 24 hours of Screening
  • Subjects, in the opinion of the Investigator, must be considered to be in generally good health other then CLBP at Screening
  • Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
  • 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 and other symptoms of CLBP or increase the risk of opioid-related adverse events
  • A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug
  • A surgical procedure for back pain within 6 months
  • A nerve or plexus block, including epidural steroid injections or facet blocks
  • A history of chemotherapy or confirmed malignancy within past 2 years
  • Any other chronic pain condition other than CLBP that, in the Investigator's opinion, would interfere with the assessment of LBP e.g. fibromyalgia, osteoarthritis, rheumatoid arthritis, migraine headaches requiring opioid treatment
  • Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure >180 mmHg or <90 mmHg, and/or a sitting diastolic blood pressure >120 mmHg or <50 mmHg at Screening
  • A Body Mass Index (BMI) >45 kg/m2
  • A Hospital Anxiety and Depression Scale (HADS) Index score of >12 in either depression or anxiety subscales or an established history of major depressive disorder that is poorly controlled with medication
  • A clinically significant abnormality in clinical chemistry, hematology or urinalysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081912

  Hide Study Locations
Locations
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, Arkansas
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Neuro-Pain Medical Center, Inc.
Fresno, California, United States, 93710
Pacific Coast Pain Management Center
Laguna Hills, California, United States, 92637
United States, Colorado
Clinicos, LLC
Colorado Springs, Colorado, United States, 80904
Interwest Rehabilitation, LLC
Littleton, Colorado, United States, 80122
United States, Connecticut
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
United States, Florida
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32257
Peninsula Research, Inc.
Ormond Beach, Florida, United States, 32174
Gold Coast Research
Plantation, Florida, United States, 33317
Clinical Research of West Florida, Inc.
Tampa, Florida, United States, 33603
United States, Georgia
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, United States, 30338
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States, 30513
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States, 30060
Georgia Clinical Research
Snellville, Georgia, United States, 30078
United States, Illinois
Suburban Clinical Research
Chicago, Illinois, United States, 60490
United States, Indiana
Destiny Clinical Research, LLC
Evansville, Indiana, United States, 47714
United States, Iowa
Integrated Clinical Trials Services, Inc.
West Des Moines, Iowa, United States, 50265
United States, Kansas
International Clinical Research Institute
Leawood, Kansas, United States, 66211
Clinical Trials Technology, Inc
Prairie Village, Kansas, United States, 66206
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
United States, Louisiana
Clinical Trials Management
Metairie, Louisiana, United States, 70006
Best Clinical Trials, LLC
New Orleans, Louisiana, United States, 70115
River Cities Clinical Research Center
Shreveport, Louisiana, United States, 71105
United States, Massachusetts
NECCR Internal Medicine & Cardiology Associates, LLC
Fall River, Massachusetts, United States, 02720
United States, Mississippi
Center for Clinical Trials
Biloxi, Mississippi, United States, 39531
United States, Montana
Research West, LLC
Kalispell, Montana, United States, 59901
United States, Nevada
Office of Danka Michaels, MD
Las Vegas, Nevada, United States, 89128
United States, New Jersey
South Jersey Medical Associates
Blackwood, New Jersey, United States, 08012
CRI Worldwide, LLC
Willingboro, New Jersey, United States, 08046
United States, New York
Five Towns Neuroscience Research
Cedarhurst, New York, United States, 11516
Upstate Clinical Research Associates
Williamsville, New York, United States, 14221
United States, North Carolina
Center for Clinical Research LLC
Winston Salem, North Carolina, United States, 27103
United States, Ohio
IVA Research
Cincinnati, Ohio, United States, 45245
Prestige Clinical Research
Franklin, Ohio, United States, 45005
United States, Oklahoma
Neuropsychiatric Research Center
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Brandywine Clinical Research
Downingtown, Pennsylvania, United States, 19335
Feasterville Family Health Care Center
Feasterville, Pennsylvania, United States, 19053
United States, Rhode Island
New England Center for Clinical Research
Cranston, Rhode Island, United States, 02920
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Integrity Clinical Research, LLC
Milan, Tennessee, United States, 38358
United States, Texas
InSite Clinical Research
DeSoto, Texas, United States, 75115
Clinical Trial Network
Houston, Texas, United States, 77074
Invisions Consultants, LLC
San Antonio, Texas, United States, 78229
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Clinical Trial Network
Spring, Texas, United States, 77386
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
United States, Virginia
Hypothe Test, LLC
Roanoke, Virginia, United States, 24018
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Zogenix, Inc.
Investigators
Study Director: Kevin Romanko, DPM Zogenix, Inc.
  More Information

No publications provided

Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01081912     History of Changes
Other Study ID Numbers: ZX002-0801
Study First Received: March 4, 2010
Results First Received: February 4, 2014
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:
chronic pain
back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 July 24, 2014