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

Chronic Pain Clinical Trial

Official title:

A 12-Month, Open-Label Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours in Patients Who Require Opioid Treatment for an Extended Period of Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223365
• Other study ID #: C33237/3080
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2010
• Last updated: May 2, 2013
• Start date: October 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Hydrocodone bitartrate extended-release tablets
Hydrocodone bitartrate extended-release tablets (CEP-33237) will be administered at doses of 15, 30, 45, 60, and 90 mg every 12 hours. The tablets used in this study contain 15, 30, or 45 mg of hydrocodone bitartrate.

Locations

Country	Name	City	State
United States	Physician Alliance Research Center	Anaheim	California
United States	Adam D. Karns, MD	Beverly Hills	California
United States	Millennium Pain Center	Bloomington	Illinois
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Associated Pharmaceutical Research Center, Inc.	Buena Park	California
United States	Providence Clinical Research	Burbank	California
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Columbus Clinical Research	Columbus	Ohio
United States	Community Research	Crestview Hills	Kentucky
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	Avail Clinical Research, LLC	DeLand	Florida
United States	Brandywine Clinical Research	Downingtown	Pennsylvania
United States	Pain Research of Oregon	Eugene	Oregon
United States	AMH Feasterville Family Health Care Center	Feasterville Trevose	Pennsylvania
United States	HealthCare Research	Florissant	Missouri
United States	Research Center of Fresno, Inc.	Fresno	California
United States	Greenville Pharmaceutical Research	Greenville	South Carolina
United States	Medstar Clinical Research	Houston	Texas
United States	Rehabilitation Associates of Indiana	Indianapolis	Indiana
United States	Pacific Coast Pain Management Center	Laguna Hills	California
United States	South Orange County Surgical Medical Group	Laguna Hills	California
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
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	Horizon Research Group, LLC	Mobile	Alabama
United States	Better Health Clinical Research, Inc.	Newnan	Georgia
United States	Trident Institute of Medical Research, LLC	North Charleston	South Carolina
United States	SP Research	Oklahoma City	Oklahoma
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Aspen Clinical Research, LLC	Orem	Utah
United States	Compass Research, LLC	Orlando	Florida
United States	International Clinical Research, Inc.	Overland Park	Kansas
United States	MidAtlantic Pain Medicine Center	Pikesville	Maryland
United States	Summit Research Network Inc.	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Benchmark Research	San Angelo	Texas
United States	Accelovance, Inc.	San Diego	California
United States	Sarasota Pain Medicine Research LLC	Sarasota	Florida
United States	Willis Knighton River Cities Clinical Research Center	Shreveport	Louisiana
United States	S. Carolina Pharmaceutical Research	Spartanburg	South Carolina
United States	Sundance Clinical Research, LLC	St. Louis	Missouri
United States	DCT-Sugarland, LLC dba Discovery Clinical Trials	Sugar Land	Texas
United States	Tipton Medical and Diagnostic Center	Tipton	Pennsylvania
United States	Bayview Research Group, LLC	Valley Village	California
United States	Advanced Pain Consultants	Voorhees	New Jersey
United States	Hillcrest Family Health Centers	Waco	Texas
United States	Omega Medical Research	Warwick	Rhode Island
United States	Clinical Research Center of Reading, LLP	West Reading	Pennsylvania
United States	Gold Coast Research LLC	Weston	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety of hydrocodone extended-release tablets	- as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.	over a 12-month treatment period	Yes
Secondary	Patient Global Assessment (PGA) of the method of pain control		at each titration visit and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	No
Secondary	Clinician Assessment of Patient Function (CAPF)		at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	No
Secondary	Patient Assessment of Function (PAF)		at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	No
Secondary	Brief Pain Inventory-Short Form (BPI-SF)		at each titration visit and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	No
Secondary	36-Item Short Form Health Survey (SF-36)		at treatment weeks 12, 24, 36, and 52	No
Secondary	World Health Organization Health and Work Performance Questionnaire (HPQ)		at last titration visit and at treatment weeks 4,12, 24, 36, and 52	No
Secondary	Sheehan Disability Scale Score		at last titration visit and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	No
Secondary	Pure Tone Audiometry		at the second and third titration visits, and at treatment weeks 24 and 52	Yes
Secondary	Screener and Opioid Assessment for Patients With Pain-Revised (SOAPP-R)		at first titration visit and at first treatment visit	Yes
Secondary	Addiction Behavior Checklist (ABC)		at first and last titration visits, and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	Yes
Secondary	Current Opioid Misuse Measure (COMM)		at first and last titration visits, and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	Yes