Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Hydrocodone ER; Placebo
Intervention description: Participants were instructed to take hydrocodone ER tablets orally with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.; During the double-blind titration period used in the original protocol, placebo tablets matching each dose of hydrocodone bitartrate ER tablets (active drug) were used to maintain the blind but not for purposes of comparison.
Intervention MeSH terms: Hydrocodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: low back pain; hydrocodone bitartrate; opioids

Summary:

      This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety
      of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe
      chronic low back pain who require continuous opioid treatment for an extended period of time.

      To be eligible for Study 3104, patients were required to have completed the entire double
      blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets)
      through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study
      3104.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have participated in and completed the entire double-blind treatment
             period on study drug through the final study visit (week 12) of study 3103.

             NOTE: Patients who had a final on-treatment visit (i.e. prior to week 12) are not
             permitted to participate in study 3104.

          2. The patient is able to speak English and is willing to provide written informed
             consent for study 3104, including re-signing a written opioid agreement, to
             participate in this study.

          3. 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.

          4. The patient must be willing and able to successfully self-administer the study drug,
             comply with study restrictions, and return to the study center for scheduled study
             visits, as specified in the protocol.

          5. The patient must not participate in any other study involving an investigational agent
             (excluding those who participated in study 3103) while enrolled in the present study.

        Exclusion Criteria:

          1. The patient's current source of pain is different from the low back pain the patient
             was experiencing at entry into study 3103. NOTE: Any additional source of pain for a
             patient must be discussed with the medical monitor.

          2. The patient has current evidence of alcohol or other substance abuse with the
             exception of nicotine or caffeine.

          3. The patient has developed, during study 3103, a medical or psychiatric disease
             (including suicidality) that, in the opinion of the investigator, would compromise
             collected data.

          4. The patient is expected to have surgery during the study.

          5. The patient is pregnant or lactating.

          6. The patient has developed an active malignancy (excluding basal cell carcinoma) during
             study 3103.

          7. The patient has known human immunodeficiency virus (HIV).

          8. 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.

          9. The patient has developed cardiopulmonary disease that would, in the opinion of the
             investigator, significantly increase the risk of treatment with opioids.

         10. The patient is receiving a monoamine oxidase inhibitor (MAOI).

               -  Other exclusion criteria apply.