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
1 other identifier
interventional
510
1 country
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2010
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
April 21, 2014
CompletedDecember 8, 2022
March 1, 2014
1.6 years
March 4, 2010
February 4, 2014
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mean Change of the Clinic NRS Pain Intensity
Baseline to Day 85 visit
Study Arms (2)
Hydrocodone Bitartrate Capsules
ACTIVE COMPARATORHydrocodone Bitartrate Controlled-Release Capsules
Placebo comparator
PLACEBO COMPARATORInterventions
Capsules, no active substance, shells identical to active comparator capsules
dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zogenix, Inc.lead
Study Sites (51)
Arizona Research Center
Phoenix, Arizona, 85023, United States
Clopton Clinic
Jonesboro, Arkansas, 72401, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Neuro-Pain Medical Center, Inc.
Fresno, California, 93710, United States
Pacific Coast Pain Management Center
Laguna Hills, California, 92637, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Interwest Rehabilitation, LLC
Littleton, Colorado, 80122, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Gold Coast Research
Plantation, Florida, 33317, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, 30338, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Georgia Clinical Research
Snellville, Georgia, 30078, United States
Suburban Clinical Research
Chicago, Illinois, 60490, United States
Destiny Clinical Research, LLC
Evansville, Indiana, 47714, United States
Integrated Clinical Trials Services, Inc.
West Des Moines, Iowa, 50265, United States
International Clinical Research Institute
Leawood, Kansas, 66211, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Clinical Trials Management
Metairie, Louisiana, 70006, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
River Cities Clinical Research Center
Shreveport, Louisiana, 71105, United States
NECCR Internal Medicine & Cardiology Associates, LLC
Fall River, Massachusetts, 02720, United States
Center for Clinical Trials
Biloxi, Mississippi, 39531, United States
Research West, LLC
Kalispell, Montana, 59901, United States
Office of Danka Michaels, MD
Las Vegas, Nevada, 89128, United States
South Jersey Medical Associates
Blackwood, New Jersey, 08012, United States
CRI Worldwide, LLC
Willingboro, New Jersey, 08046, United States
Five Towns Neuroscience Research
Cedarhurst, New York, 11516, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Center for Clinical Research LLC
Winston-Salem, North Carolina, 27103, United States
IVA Research
Cincinnati, Ohio, 45245, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Neuropsychiatric Research Center
Oklahoma City, Oklahoma, 73109, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335, United States
Feasterville Family Health Care Center
Feasterville, Pennsylvania, 19053, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Integrity Clinical Research, LLC
Milan, Tennessee, 38358, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Invisions Consultants, LLC
San Antonio, Texas, 78229, United States
Clinical Trial Network
Spring, Texas, 77386, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Hypothe Test, LLC
Roanoke, Virginia, 24018, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Romanko
- Organization
- Zogenix
Study Officials
- STUDY DIRECTOR
Kevin Romanko, DPM
Zogenix, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
December 8, 2022
Results First Posted
April 21, 2014
Record last verified: 2014-03