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
CompletedPhase 3NCT01223365
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Start date
- 2010-10
- Primary completion
- 2012-09
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 54
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 an…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01223365