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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01223365
First received: October 15, 2010
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: Hydrocodone bitartrate extended-release tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Evaluate the safety of hydrocodone extended-release tablets [ Time Frame: over a 12-month treatment period ] [ Designated as safety issue: Yes ]
    - as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.


Secondary Outcome Measures:
  • Patient Global Assessment (PGA) of the method of pain control [ Time Frame: at each titration visit and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ] [ Designated as safety issue: No ]
  • Clinician Assessment of Patient Function (CAPF) [ Time Frame: at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ] [ Designated as safety issue: No ]
  • Patient Assessment of Function (PAF) [ Time Frame: at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ] [ Designated as safety issue: No ]
  • Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: at each titration visit and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ] [ Designated as safety issue: No ]
  • 36-Item Short Form Health Survey (SF-36) [ Time Frame: at treatment weeks 12, 24, 36, and 52 ] [ Designated as safety issue: No ]
  • World Health Organization Health and Work Performance Questionnaire (HPQ) [ Time Frame: at last titration visit and at treatment weeks 4,12, 24, 36, and 52 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale Score [ Time Frame: at last titration visit and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ] [ Designated as safety issue: No ]
  • Pure Tone Audiometry [ Time Frame: at the second and third titration visits, and at treatment weeks 24 and 52 ] [ Designated as safety issue: Yes ]
  • Screener and Opioid Assessment for Patients With Pain-Revised (SOAPP-R) [ Time Frame: at first titration visit and at first treatment visit ] [ Designated as safety issue: Yes ]
  • Addiction Behavior Checklist (ABC) [ Time Frame: at first and last titration visits, and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ] [ Designated as safety issue: Yes ]
  • Current Opioid Misuse Measure (COMM) [ Time Frame: at first and last titration visits, and at treatment weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ] [ Designated as safety issue: Yes ]

Enrollment: 294
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocodone bitartrate extended-release tablets (CEP-33237) 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223365

  Show 54 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert, MD Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01223365     History of Changes
Other Study ID Numbers: C33237/3080
Study First Received: October 15, 2010
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Chronic Pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hydrocodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 27, 2014