Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Condition(s) targeted: Pain

Intervention: Hydrocodone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cephalon

Official(s) and/or principal investigator(s):
Sponsor's Medical Expert, MD, Study Director, Affiliation: Cephalon

Overall contact:
Cephalon Contact, Phone: 1-877-237-4879

The primary objective of this study is to evaluate efficacy of hydrocodone extended-release tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in the weekly Average Pain Intensity (API)

Secondary outcome:

Percentage of patients who withdraw from the study

Time from baseline to patient withdrawal from the study

Weekly average of daily API scores

Weekly average of daily Worst Pain Intensity (WPI)

Weekly API increase from baseline exceeding 33% and 50%

Rescue medication usage

Rescue medication usage

Clinician Assessment of Patient Function (CAPF) ratings

Patient Assessment of Function (PAF) ratings

Clinician Global Impression of Severity of Illness (CGI-S) ratings in regard to pain

Brief Pain Inventory-Short Form (BPI-SF) scores

36-Item Short Form Health Survey (SF-36) scores

Evaluate the safety and tolerability of hydrocodone extended-release tablets

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The patient is able to speak English and is willing to provide written informed

consent, including a written opioid agreement, to participate in this study.

- The patient must be willing and able to successfully self-administer the study drug,

comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol.

- 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.

- The patient has pain of at least 3 months' duration associated with osteoarthritis or

low back pain.

- The patient reports an average pain intensity score, over the prior 24 hours, of 5 or

more on the NRS-11.

- If the patient is receiving physical therapy, biofeedback therapy, acupuncture

therapy, or herbal remedies, these therapies must remain unchanged during the study.

- The patient must not participate in other study involving an investigational agent

while enrolled into the present study.

Exclusion Criteria:

- The patient has known or suspected hypersensitivities, allergies, or other

contraindications to any ingredient in the study drug.

- The patient has a recent history (within 5 years) or current evidence of alcohol or

other substance abuse with the exception of nicotine or caffeine.

- The patient has medical or psychiatric disease that, in the opinion of the

investigator, would compromise collected data.

- The patient is taking a total (ie, around-the-clock plus rescue medication) of more

than 135 mg/day of oxycodone, or equivalent, during the 14 days prior to screening.

- The patient has a history of suicidality.

- The patient is expected to have surgery during the study.

- The patient's primary painful condition under study is related to any source of

chronic pain other than osteoarthritis or low back 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 opioids.

- The patient has participated in a study involving an investigational drug in the

previous 30 days.

- 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 pain currently being

treated.

- The patient has a positive urine drug screen (UDS) that is not medically explainable.

- The investigator feels that the patient is not suitable for the study for any reason.

Cephalon Contact, Phone: 1-877-237-4879

Radiant Research, Inc., Chandler, Arizona 85225, United States; Recruiting
Central Contact

Radiant Research, Inc., Scottsdale, Arizona 85251, United States; Recruiting
Central Contact

Radiant Research Inc., Tucson, Arizona 85710, United States; Recruiting
Central Contact

Physician Alliance Research Center, Anaheim, California 92804, United States; Recruiting
Central Contact

Associated Pharmaceutical Research Center, Inc., Buena Park, California 90620, United States; Recruiting
Central Contact

Providence Clinical Research, Burbank, California 91505, United States; Recruiting
Central Contact

Synergy Clinical Research, Escondido, California 92025, United States; Recruiting
Central Contact

Research Center of Fresno, Inc., Fresno, California 93726, United States; Recruiting
Central Contact

Pacific Coast Pain Management Center, Laguna Hills, California 92637, United States; Recruiting
Central Contact

South Orange County Surgical Medical Group, Laguna Hills, California 92653, United States; Recruiting
Central Contact

Robert M. Karns, MD A Medical Corporation, Los Angeles, California 90036, United States; Recruiting
Central Contact

Accelovance, Inc., San Diego, California 92108, United States; Recruiting
Central Contact

Radiant Research, Inc., Santa Rosa, California 95405, United States; Recruiting
Central Contact

Bayview Research Group, LLC, Valley Village, California 91607, United States; Recruiting
Central Contact

Radiant Research, Inc, Denver, Colorado 80239, United States; Recruiting
Central Contact

Clinical Research of West Florida, Inc., Clearwater, Florida 33765, United States; Recruiting
Central Contact

Avail Clinical Research, LLC, DeLand, Florida 32720, United States; Recruiting
Central Contact

International Research Associates, LLC, Miami, Florida 33183, United States; Recruiting
Central Contact

Compass Research, Orlando, Florida 32806, United States; Recruiting
Central Contact

Radiant Research, Inc., Pinellas Park, Florida 33781, United States; Recruiting
Central Contact

Gold Coast Research LLC, Plantation, Florida 33317, United States; Recruiting
Central Contact

Sarasota Pain Medicine Research LLC, Sarasota, Florida 34238, United States; Recruiting
Central Contact

Clinical Research of West Florida, Inc., Tampa, Florida 33603, United States; Recruiting
Central Contact

Georgia Institute for Clinical Research, LLC, Marietta, Georgia 30060, United States; Recruiting
Central Contact

Drug Studies America, Marietta, Georgia 30060, United States; Recruiting
Central Contact

Better Health Clinical Research, Inc., Newnan, Georgia 30265, United States; Recruiting
Central Contact

Millennium Pain Center, Bloomington, Illinois 61701, United States; Recruiting
Central Contact

Medex Healthcare Research, Inc., Chicago, Illinois 60603, United States; Recruiting
Central Contact

Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States; Recruiting
Central Contact

International Clinical Research, Inc., Leawood, Kansas 66211, United States; Recruiting
Central Contact

Community Research, Crestview, Kentucky 41017, United States; Recruiting
Central Contact

The Pain Treatment Center of the Bluegrass, Lexington, Kentucky 40503, United States; Recruiting
Central Contact

Horizon Research Group, LLC, Baton Rouge, Louisiana 70809, United States; Recruiting
Central Contact

WK River Cities Clinical Research Center, Shreveport, Louisiana 71105, United States; Recruiting
Central Contact

MidAtlantic Pain Medicine Center, Pikesville, Maryland 21208, United States; Recruiting
Central Contact

Beacon Clinical Research, LLC, Brockton, Massachusetts 02301, United States; Recruiting
Central Contact

HealthCare Research, Florissant, Missouri 63031, United States; Recruiting
Central Contact

Sundance Clinical Research, LLC, St. Louis, Missouri 63141, United States; Recruiting
Central Contact

Meridian Clinical Research, Omaha, Nebraska 68134, United States; Recruiting
Central Contact

Clinical Research Center of Nevada, Las Vegas, Nevada 89104, United States; Recruiting
Central Contact

Advanced Pain Consultants, Voorhees, New Jersey 08043, United States; Recruiting
Central Contact

Upstate Clinical Research Associates, Williamsville, New York 14221, United States; Recruiting
Central Contact

Wake Research Associates, Raleigh, North Carolina 27612, United States; Recruiting
Central Contact

Radiant Research, Inc, Akron, Ohio 44311, United States; Recruiting
Central Contact

Community Research, Inc, Cincinnati, Ohio 45227, United States; Recruiting
Central Contact

Sterling Research Group, Ltd., Cincinnati, Ohio 45219, United States; Recruiting
Central Contact

Community Research, Inc, Cincinnati, Ohio 45245, United States; Recruiting
Central Contact

Rapid Medical Research, Cleveland, Ohio 44122, United States; Recruiting
Central Contact

Columbus Clinical Research, Columbus, Ohio 43213, United States; Recruiting
Central Contact

SP Research, Oklahoma City, Oklahoma 73112, United States; Recruiting
Central Contact

Pain Research of Oregon, Eugene, Oregon 97401, United States; Recruiting
Central Contact

Summit Research Network Inc., Portland, Oregon 97210, United States; Recruiting
Central Contact

Brandywine Clinical Research, Downingtown, Pennsylvania 19335, United States; Recruiting
Central Contact

Tipton Medical and Diagnostic Center, Tipton, Pennsylvania 16684, United States; Recruiting
Central Contact

AMH Feasterville Family Health Care Center, Trevose, Pennsylvania 19053, United States; Recruiting
Central Contact

Clinical Research Center of Reading, Wyomissing, Pennsylvania 19610, United States; Recruiting
Central Contact

Omega Medical Research, Warwick, Rhode Island 02886, United States; Recruiting
Central Contact

Radiant Research Inc., Anderson, South Carolina 29621, United States; Recruiting
Central Contact

Greenville Pharmaceutical Research, Greenville, South Carolina 29615, United States; Recruiting
Central Contact

Radiant Research, Inc, Greer, South Carolina 29651, United States; Recruiting
Central Contact

Trident Institute of Medical Research, LLC, North Charleston, South Carolina 29406, United States; Recruiting
Central Contact

South Carolina Pharmaceutical Research, Spartanburg, South Carolina 29303, United States; Recruiting
Central Contact

KRK Medical Research, Dallas, Texas 75230, United States; Recruiting
Central Contact

Radiant Research Dallas, Dallas, Texas 75231, United States; Recruiting
Central Contact

Renaissance Clinical Research & Hypertension of Texas, PLLC, Dallas, Texas 75235, United States; Recruiting
Central Contact

Medstar Clinical Research, Houston, Texas 77083, United States; Recruiting
Central Contact

Benchmark Research, San Angelo, Texas 76904, United States; Recruiting
Central Contact

DCT-Sugarland, LLC, Sugar Land, Texas 77478, United States; Recruiting
Central Contact

Hillcrest Family Health Centers, Waco, Texas 76710, United States; Recruiting
Central Contact

Aspen Clinical Research, LLC, Orem, Utah 84058, United States; Recruiting
Central Contact

Lifetree Clinical Research, Salt Lake City, Utah 84106, United States; Recruiting
Central Contact

Starting date: November 2010
Last updated: July 8, 2011