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

Completed · Phase 3 · Has a placebo group

Conditions studied: Low Back Pain

In brief

The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experienced.

Key facts

Study ID

NCT01789970

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

625

Starts

2013-03-01

Expected to finish

2014-02-01

Last updated by the study team

2017-06-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Teva Investigational Site 10382 — Birmingham, Alabama, United States
• Teva Investigational Site 10403 — Birmingham, Alabama, United States
• Teva Investigational Site 10412 — Birmingham, Alabama, United States
• Teva Investigational Site 10426 — Mobile, Alabama, United States
• Teva Investigational Site 10436 — Montgomery, Alabama, United States
• Teva Investigational Site 10363 — Phoenix, Arizona, United States
• Teva Investigational Site 10366 — Phoenix, Arizona, United States
• Teva Investigational Site 10437 — Tucson, Arizona, United States
• Teva Investigational Site 10358 — Anaheim, California, United States
• Teva Investigational Site 10408 — Bell Gardens, California, United States
• Teva Investigational Site 10425 — Carmichael, California, United States
• Teva Investigational Site 10390 — Cerritos, California, United States
• Teva Investigational Site 10429 — El Cajon, California, United States
• Teva Investigational Site 10423 — Escondido, California, United States
• Teva Investigational Site 10740 — Garden Grove, California, United States
• Teva Investigational Site 10391 — Huntington Park, California, United States
• Teva Investigational Site 10422 — La Jolla, California, United States
• Teva Investigational Site 10413 — Laguna Hills, California, United States
• Teva Investigational Site 10442 — Laguna Hills, California, United States
• Teva Investigational Site 10370 — Los Angeles, California, United States
• Teva Investigational Site 10392 — Sherman Oaks, California, United States
• Teva Investigational Site 10398 — Thousand Oaks, California, United States
• Teva Investigational Site 10428 — Torrance, California, United States
• Teva Investigational Site 10361 — Walnut Creek, California, United States
• Teva Investigational Site 10416 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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