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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081912
• Other study ID #: ZX002-0801
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2014
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

Intervention

Drug:
• Placebo
Capsules, no active substance, shells identical to active comparator capsules
• Hydrocodone bitartrate
dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zogenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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