Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

Chronic Pain Clinical Trial

Official title:

A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115569
• Other study ID #: ZX002-0802
• Status: Completed
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: January 2012

Study information

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

Clinical Trial Summary

This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Description:

Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain

• Subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone

• Subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months

• Females subjects of childbearing potential must have a negative urine pregnancy test at the Screen Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.

• Subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition

• 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 or increase the risk of opioid-related adverse events (AEs)

• A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete study drug

• A surgical procedure for pain within the last 3 months

• Uncontrolled blood pressure, i.e., a sitting systolic blood pressure >180 mm Hg or <90 mm Hg, and/or a sitting diastolic blood pressure >120 mm Hg or <50 mm Hg at Screening

• A body mass index (BMI) > 45 kg/m2

• A hospital anxiety and depression scale (HADS) score of >12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled

• A clinically significant abnormality in clinical chemistry, hematology or urinalysis

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Hydrocodone Bitartrate
Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks

Locations

Country	Name	City	State
United States	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico
United States	Blair Medical Associates	Altoona	Pennsylvania
United States	Pain Institute of California	Bakersfield	California
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Nautical Clinical Research, LLC	Boise	Idaho
United States	Suburban Clinical Research	Bolingbrook	Illinois
United States	Providence Clinical Research	Burbank	California
United States	Valley Medical Group, PC	Centerville	Ohio
United States	West Side Medical	Clinton	Utah
United States	New England Center for Clinical Research, Inc.	Cranston	Rhode Island
United States	Renaissance Clinical Research and Hypertension Clinic	Dallas	Texas
United States	Best Clinical Research	Decatur	Georgia
United States	New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC	Fall River	Massachusetts
United States	The Clinical Research Center, LLC	Fort Worth	Texas
United States	Prestige Clinical Research	Franklin	Ohio
United States	Mountain View Clinical Research, Inc.	Golden	Colorado
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	Clinical Trial Network	Houston	Texas
United States	Heights Doctors Clinic	Houston	Texas
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Research West, LLC	Kalispell	Montana
United States	South Orange County Surgical Medical Group	Laguna Hills	California
United States	International Clinical Research Institute, Inc.	Leawood	Kansas
United States	Ortho Research	Little Rock	Arkansas
United States	Clinical Trials Managements, LLC	Mandeville	Louisiana
United States	Georgia Institute for Clinical Research, LLC	Marietta	Georgia
United States	New York University Pain Management Center	New York	New York
United States	Better Health Clinical Research, Inc	Newnan	Georgia
United States	Infinity Medical Research, Inc.	North Dartmouth	Massachusetts
United States	Hillcrest Clinical Research, Inc.	Oklahoma City	Oklahoma
United States	Memorial Clinical Research DBA Angelique Barreto, MD	Oklahoma City	Oklahoma
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	HOPE Research Institute, LLC	Phoenix	Arizona
United States	Gold Coast Research, LLC	Plantation	Florida
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	Mercy Health Research	Saint Louis	Missouri
United States	Jean Brown Research	Salt Lake City	Utah
United States	Quality Research, Inc.	San Antonio	Texas
United States	Scripps Clinic, Clinical Research	San Diego	California
United States	Willis-Knighton Physician Network	Shreveport	Louisiana
United States	Cochise Clinical Research	Sierra Vista	Arizona
United States	Mid-South Anesthesia Consultants	Southaven	Mississippi
United States	Clinvest	Springfield	Missouri
United States	Hometown Urgent Care and Research	Springfield	Ohio
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Advanced Research Institute, Inc.	Trinity	Florida
United States	Advanced Pain Management	Virginia Beach	Virginia
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina
United States	National Pain Research Institute, Inc.	Winter Park	Florida

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 Average Daily Pain	Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.	1 year
Secondary	Maintenance of Efficacy	Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication	1 year