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

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain Lower Back Chronic
• Intervention / Treatment: Drug: Hydrocodone bitartrate; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo comparator	Drug: Placebo; Capsules, no active substance, shells identical to active comparator capsules; Other Names: Sugar pill
Active Comparator: Hydrocodone Bitartrate Capsules; Hydrocodone Bitartrate Controlled-Release Capsules	Drug: Hydrocodone bitartrate; dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).	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.	Baseline to Day 85 (Treatment Phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change of the Clinic NRS Pain Intensity	The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)	Baseline to Day 85 visit

Collaborators and Investigators

• Sponsor: Zogenix, Inc.
• Investigators: Study Director: Kevin Romanko, DPM, Zogenix, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 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; back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back 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: ZX002-0801