Back Pain Lower Back Chronic Clinical Trial
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
NCT number | NCT01081912 |
Other study ID # | ZX002-0801 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2010 |
Est. completion date | October 2011 |
Verified date | March 2014 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 510 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Advanced Clinical Research Institute | Anaheim | California |
United States | Perimeter Institute for Clinical Research, Inc. | Atlanta | Georgia |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Center for Clinical Trials | Biloxi | Mississippi |
United States | South Jersey Medical Associates | Blackwood | New Jersey |
United States | River Birch Research Alliance, LLC | Blue Ridge | Georgia |
United States | Five Towns Neuroscience Research | Cedarhurst | New York |
United States | Suburban Clinical Research | Chicago | Illinois |
United States | IVA Research | Cincinnati | Ohio |
United States | Clinical Research of West Florida, Inc. | Clearwater | Florida |
United States | Clinicos, LLC | Colorado Springs | Colorado |
United States | New England Center for Clinical Research | Cranston | Rhode Island |
United States | InSite Clinical Research | DeSoto | Texas |
United States | Brandywine Clinical Research | Downingtown | Pennsylvania |
United States | Destiny Clinical Research, LLC | Evansville | Indiana |
United States | NECCR Internal Medicine & Cardiology Associates, LLC | Fall River | Massachusetts |
United States | Feasterville Family Health Care Center | Feasterville | Pennsylvania |
United States | Prestige Clinical Research | Franklin | Ohio |
United States | Neuro-Pain Medical Center, Inc. | Fresno | California |
United States | Clinical Trial Network | Houston | Texas |
United States | Florida Institute of Medical Research | Jacksonville | Florida |
United States | Clopton Clinic | Jonesboro | Arkansas |
United States | Research West, LLC | Kalispell | Montana |
United States | Pacific Coast Pain Management Center | Laguna Hills | California |
United States | Office of Danka Michaels, MD | Las Vegas | Nevada |
United States | International Clinical Research Institute | Leawood | Kansas |
United States | Interwest Rehabilitation, LLC | Littleton | Colorado |
United States | Georgia Institute for Clinical Research, LLC | Marietta | Georgia |
United States | Clinical Trials Management | Metairie | Louisiana |
United States | Integrity Clinical Research, LLC | Milan | Tennessee |
United States | Best Clinical Trials, LLC | New Orleans | Louisiana |
United States | Advanced Research Institute | Ogden | Utah |
United States | Neuropsychiatric Research Center | Oklahoma City | Oklahoma |
United States | Peninsula Research, Inc. | Ormond Beach | Florida |
United States | Arizona Research Center | Phoenix | Arizona |
United States | Gold Coast Research | Plantation | Florida |
United States | Clinical Trials Technology, Inc | Prairie Village | Kansas |
United States | Health Concepts | Rapid City | South Dakota |
United States | Hypothe Test, LLC | Roanoke | Virginia |
United States | Innovative Clinical Trials | San Antonio | Texas |
United States | Invisions Consultants, LLC | San Antonio | Texas |
United States | River Cities Clinical Research Center | Shreveport | Louisiana |
United States | Georgia Clinical Research | Snellville | Georgia |
United States | Clinical Trial Network | Spring | Texas |
United States | Stamford Therapeutics Consortium | Stamford | Connecticut |
United States | Clinical Research of West Florida, Inc. | Tampa | Florida |
United States | Cotton O'Neil Clinical Research Center | Topeka | Kansas |
United States | Integrated Clinical Trials Services, Inc. | West Des Moines | Iowa |
United States | Upstate Clinical Research Associates | Williamsville | New York |
United States | CRI Worldwide, LLC | Willingboro | New Jersey |
United States | Center for Clinical Research LLC | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Zogenix, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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