Clinical trial NCT01115569: Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: chronic pain
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Average Daily Pain
timeFrame: 1 year
Secondary outcomes:
measure: Maintenance of Efficacy
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute, LLC
state: Arizona
city: Sierra Vista
country: United States
facility: Cochise Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Ortho Research
state: Arkansas
city: Bakersfield
country: United States
facility: Pain Institute of California
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: San Diego
country: United States
facility: Scripps Clinic, Clinical Research
state: California
city: Golden
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Winter Park
country: United States
facility: National Pain Research Institute, Inc.
state: Florida
city: Decatur
country: United States
facility: Best Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc
state: Georgia
city: Boise
country: United States
facility: Nautical Clinical Research, LLC
state: Idaho
city: Bolingbrook
country: United States
facility: Suburban Clinical Research
state: Illinois
city: Leawood
country: United States
facility: International Clinical Research Institute, Inc.
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc.
state: Kansas
city: Mandeville
country: United States
facility: Clinical Trials Managements, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research, Inc.
state: Massachusetts
city: Southaven
country: United States
facility: Mid-South Anesthesia Consultants
state: Mississippi
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Kalispell
country: United States
facility: Research West, LLC
state: Montana
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: New York
country: United States
facility: New York University Pain Management Center
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Group, PC
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Springfield
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Oklahoma City
country: United States
facility: Hillcrest Clinical Research, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Memorial Clinical Research DBA Angelique Barreto, MD
state: Oklahoma
city: Altoona
country: United States
facility: Blair Medical Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research, Inc.
state: Rhode Island
city: Dallas
country: United States
facility: Renaissance Clinical Research and Hypertension Clinic
state: Texas
city: Fort Worth
country: United States
facility: The Clinical Research Center, LLC
state: Texas
city: Houston
country: United States
facility: Heights Doctors Clinic
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: Clinton
country: United States
facility: West Side Medical
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Virginia Beach
country: United States
facility: Advanced Pain Management
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Zogenix, Inc.
name: Vickie Gorgone
role: STUDY_DIRECTOR
References: