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

About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring chronic low back pain, hydrocodone bitartrate, opioids
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.
Sites / Locations
- Teva Investigational Site 10416
- Teva Investigational Site 10382
- Teva Investigational Site 10403
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- Teva Investigational Site 10426
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- Teva Investigational Site 10740
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- Teva Investigational Site 12036
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- Teva Investigational Site 10435
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- Teva Investigational Site 10383
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- Teva Investigational Site 10439
- Teva Investigational Site 10394
- Teva Investigational Site 10407
- Teva Investigational Site 10410
- Teva Investigational Site 10443
- Teva Investigational Site 10414
- Teva Investigational Site 10446
- Teva Investigational Site 10415
- Teva Investigational Site 10430
- Teva Investigational Site 10386
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- Teva Investigational Site 10404
- Teva Investigational Site 10741
- Teva Investigational Site 10405
- Teva Investigational Site 10364
- Teva Investigational Site 10372
- Teva Investigational Site 10395
- Teva Investigational Site 10371
- Teva Investigational Site 12035
- Teva Investigational Site 10377
- Teva Investigational Site 10374
- Teva Investigational Site 10378
- Teva Investigational Site 10402
- Teva Investigational Site 10438
- Teva Investigational Site 10420
- Teva Investigational Site 10433
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Hydrocodone ER
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the treatment period, participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step-wise, double-blind schedule to tamper off active drug was implemented during the first 2 weeks of the 12-week, double-blind, placebo-controlled treatment period to reduce the risk of withdrawal effects in participants randomly assigned to placebo.
Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the 12-week, double-blind, placebo-controlled treatment period, participants randomly assigned to hydrocodone ER were administered tablets twice a day at the dosage deemed successful for managing their pain during the titration period.