Clinical trial NCT01081912: Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain Lower Back Chronic
Keywords: chronic pain
back pain
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).
timeFrame: Baseline to Day 85 (Treatment Phase)
Secondary outcomes:
measure: Mean Change of the Clinic NRS Pain Intensity
timeFrame: Baseline to Day 85 visit
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Jonesboro
country: United States
facility: Clopton Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center, Inc.
state: California
city: Laguna Hills
country: United States
facility: Pacific Coast Pain Management Center
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Littleton
country: United States
facility: Interwest Rehabilitation, LLC
state: Colorado
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research, Inc.
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research, Inc.
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Snellville
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Suburban Clinical Research
state: Illinois
city: Evansville
country: United States
facility: Destiny Clinical Research, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trials Services, Inc.
state: Iowa
city: Leawood
country: United States
facility: International Clinical Research Institute
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Metairie
country: United States
facility: Clinical Trials Management
state: Louisiana
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: Shreveport
country: United States
facility: River Cities Clinical Research Center
state: Louisiana
city: Fall River
country: United States
facility: NECCR Internal Medicine & Cardiology Associates, LLC
state: Massachusetts
city: Biloxi
country: United States
facility: Center for Clinical Trials
state: Mississippi
city: Kalispell
country: United States
facility: Research West, LLC
state: Montana
city: Las Vegas
country: United States
facility: Office of Danka Michaels, MD
state: Nevada
city: Blackwood
country: United States
facility: South Jersey Medical Associates
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Cedarhurst
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Winston-Salem
country: United States
facility: Center for Clinical Research LLC
state: North Carolina
city: Cincinnati
country: United States
facility: IVA Research
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Neuropsychiatric Research Center
state: Oklahoma
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Feasterville
country: United States
facility: Feasterville Family Health Care Center
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Milan
country: United States
facility: Integrity Clinical Research, LLC
state: Tennessee
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Invisions Consultants, LLC
state: Texas
city: Spring
country: United States
facility: Clinical Trial Network
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Roanoke
country: United States
facility: Hypothe Test, LLC
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Zogenix, Inc.
name: Kevin Romanko, DPM
role: STUDY_DIRECTOR
References: