Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Feb 8, 2013

Keywords

ClinConnect Summary

The study consisted of a screening period of approximately 7 to 14 days, an open label titration period of up to 6 weeks, and a double blind treatment period of 12 weeks.

The objective of the open label titration period was to find the successful dose of hydrocodone extended release (ER) tablets that produced stable pain relief without unacceptable adverse events (AEs). Stable pain relief was defined as an average pain intensity (API) score over the previous 24 hours of 4 or less and a worst pain intensity (WPI) score of 6 or less on the 11-point numerical rating scale (NRS-11) (0=no pain ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient has had moderate to severe chronic low back pain for at least 3 months duration before screening.
• • 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 is willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the study center for scheduled study visits, as specified in the protocol.
• • The patient is 18 through 80 years of age at the time of screening.
• • Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception, 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. - Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. NOTE: A woman will be considered surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy.
• • Other criteria apply.
• Exclusion Criteria:
• • The patient is taking a total of more than 135 mg/day of oxycodone, or equivalent, during the 14 days before screening.
• • The patient's primary painful condition under study is related to any source of chronic pain other than low back pain.
• • The patient has radicular (nerve compression) pain or another type of purely neuropathic pain.
• • 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.
• • The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
• • Other criteria apply.