Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

NCT ID: NCT01223365

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-09-30

Brief Summary

The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.

Detailed Description

This was a Phase 3, open-label, nonrandomized study that consisted of a screening period, an open label titration period, and a 52 week, long term, open-label treatment period in patients with chronic pain. Patients were eligible to participate in this study if they had completed study C33237/3079 (NCT01240863) (these patients are hereafter referred to as rollover patients) or if they had not participated in study 3079 (these patients are hereafter referred to as either new opioid naïve or new opioid experienced patients).

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrocodone ER

Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg orally every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.

Group Type: EXPERIMENTAL

Hydrocodone ER

Intervention Type: DRUG

Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.

Interventions

Hydrocodone ER

Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.

Intervention Type: DRUG

Other Intervention Names

CEP-33237; Hydrocodone bitartrate extended-release

Eligibility Criteria

Inclusion Criteria

• The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, and return to the clinic for scheduled study visits as specified in this protocol.
• The patient has either completed Cephalon study 3079 or has chronic pain of at least 3 months duration prior to entering this study associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, osteoarthritis, or rheumatoid arthritis. Patients with other painful conditions may qualify for the study with permission from the Cephalon medical monitor or designee.
• Those patients who completed the 12-week, double-blind, placebo-controlled, randomized study (study 3079) and are willing to re-titrate study drug to an effective dose of hydrocodone extended-release tablets are eligible to enter this study.
• The patient is able to speak English, willing to provide written informed consent, and sign a written opioid agreement, to participate in this study.
• The patient is 18 through 80 years of age (inclusive) at the time of entering this or the previous study (study 3079).
• Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening.

Exclusion Criteria

• Patients who were enrolled in study 3079 but did not complete the 12-week, double-blind, placebo-controlled, randomized study may not be enrolled into this study.
• The patient has known or suspected hypersensitivities, allergies, or other contraindications to the study drug or its excipients.
• The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
• The patient has a medical or psychiatric condition/disease that, in the opinion of the investigator, would compromise collected data.
• The patient is taking a total (i.e., including around-the clock [ATC] and rescue medications) of more than 135 mg/day of oxycodone or equivalent for 14 days prior to screening.
• The patient has a history of suicidality.
• The patient has a diagnosis of chronic headache or migraine as the primary painful condition under study.
• The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain.
• The patient is pregnant or lactating.
• The patient has active malignancy.
• The patient has human immunodeficiency virus (HIV).
• In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination and/or clinical laboratory test values.
• The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids.
• The patient has participated in a study involving an investigational drug in the previous 30 days (excluding those who participated in study 3079).
• The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
• The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
• The patient is involved in active litigation in regard to the chronic pain currently being treated.
• The patient has a positive urine drug screen (UDS) for an illicit substance or medication not prescribed by the physician currently treating the chronic pain.
• The investigator feels that the patient is not suitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert, MD

Role: STUDY_DIRECTOR

Cephalon

Locations

Horizon Research Group, LLC

Mobile, Alabama, United States

Physician Alliance Research Center

Anaheim, California, United States

Adam D. Karns, MD

Beverly Hills, California, United States

Associated Pharmaceutical Research Center, Inc.

Buena Park, California, United States

Providence Clinical Research

Burbank, California, United States

Research Center of Fresno, Inc.

Fresno, California, United States

Pacific Coast Pain Management Center

Laguna Hills, California, United States

South Orange County Surgical Medical Group

Laguna Hills, California, United States

Accelovance, Inc.

San Diego, California, United States

Bayview Research Group, LLC

Valley Village, California, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Compass Research, LLC

Orlando, Florida, United States

Sarasota Pain Medicine Research LLC

Sarasota, Florida, United States

Gold Coast Research LLC

Weston, Florida, United States

Drug Studies America

Marietta, Georgia, United States

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, United States

Taylor Research, LLC

Marietta, Georgia, United States

Better Health Clinical Research, Inc.

Newnan, Georgia, United States

Millennium Pain Center

Bloomington, Illinois, United States

Rehabilitation Associates of Indiana

Indianapolis, Indiana, United States

International Clinical Research, Inc.

Overland Park, Kansas, United States

Community Research

Crestview Hills, Kentucky, United States

Willis Knighton River Cities Clinical Research Center

Shreveport, Louisiana, United States

MidAtlantic Pain Medicine Center

Pikesville, Maryland, United States

Beacon Clinical Research, LLC

Brockton, Massachusetts, United States

HealthCare Research

Florissant, Missouri, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Meridian Clinical Research

Omaha, Nebraska, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

Advanced Pain Consultants

Voorhees Township, New Jersey, United States

Upstate Clinical Research Associates

Williamsville, New York, United States

Wake Research Associates

Raleigh, North Carolina, United States

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Columbus Clinical Research

Columbus, Ohio, United States

SP Research

Oklahoma City, Oklahoma, United States

Pain Research of Oregon

Eugene, Oregon, United States

Summit Research Network Inc.

Portland, Oregon, United States

Brandywine Clinical Research

Downingtown, Pennsylvania, United States

AMH Feasterville Family Health Care Center

Feasterville-Trevose, Pennsylvania, United States

Tipton Medical and Diagnostic Center

Tipton, Pennsylvania, United States

Clinical Research Center of Reading, LLP

West Reading, Pennsylvania, United States

Omega Medical Research

Warwick, Rhode Island, United States

Greenville Pharmaceutical Research

Greenville, South Carolina, United States

Trident Institute of Medical Research, LLC

North Charleston, South Carolina, United States

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, United States

KRK Medical Research

Dallas, Texas, United States

Radiant Research

Dallas, Texas, United States

Renaissance Clinical Research & Hypertension of Texas, PLLC

Dallas, Texas, United States

Medstar Clinical Research

Houston, Texas, United States

Benchmark Research

San Angelo, Texas, United States

DCT-Sugarland, LLC dba Discovery Clinical Trials

Sugar Land, Texas, United States

Hillcrest Family Health Centers

Waco, Texas, United States

Aspen Clinical Research, LLC

Orem, Utah, United States

Countries

United States

Other Identifiers

C33237/3080

Identifier Type: -

Identifier Source: org_study_id