Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: OROS hydromorphone; Placebo
Intervention description: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets; Placebo
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Back Pain; Chronic Low Back Pain; Chronic Back Pain; Pain; Chronic Pain

Summary:

      This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl)
      (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical
      studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved
      in both the US and Europe to treat chronic pain.

      The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe
      and efficacious.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients must have been provided with written consent to participate in the study
             prior to any study procedures, and must understand that they are free to withdraw from
             the study at any time.

          2. Patients who can speak, read, write, and understand English, and must be able to read
             and understand the consent form, complete study-related procedures, and communicate
             with the study staff.

          3. Male and female patients aged 18-75 years, inclusive.

          4. Documented diagnosis of moderate to severe chronic low back pain that must have been
             present

          5. Patients who are classified as non-neuropathic (Class 1 and 2) or neuropathic (Class
             3, 4, 5 and 6) of lower back pain based on the Quebec Task Force Classification of
             Spinal Disorders will be enrolled for this study.

          6. Patients who require daily scheduled opioid analgesics for low back pain for at least
             2 months prior to the screening visit.

          7. Patients with a daily opioid requirement of ≥ 60 mg oral morphine equivalent (≥ 12 mg
             hydromorphone), but ≤ 320 mg morphine (≤ 64 mg hydromorphone) per day within the 2
             months prior to the screening visit.

          8. Patients who, in the Investigator's opinion, are on a stable dose (≥ 2 weeks) of all
             prior analgesics (both opioid and non-opioid) prior to the screening visit.

          9. Female subjects of childbearing potential including those who have had a tubal
             ligation surgery but excluding those who have not experienced a menstrual period for a
             minimum of 2 years, must have a negative serum pregnancy test at screening visit, and
             must consent to utilize a medically acceptable method of contraception throughout the
             entire study period including the washout period and for 1 week after the study is
             completed.

        Exclusion Criteria

          1. Patients with an active diagnosis of fibromyalgia, complex regional pain syndrome
             (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression,
             severe or progressive lower extremity weakness or numbness, bowel or bladder
             dysfunction as a result of cauda equina compression, diabetic amyotrophy, meningitis,
             diskitis, back pain because of secondary infection or tumor, or pain caused by a
             confirmed or suspected neoplasm.

          2. Patients who have undergone a surgical procedure for back pain within 6 months prior
             to the screening visit.

          3. Patients who have had nerve or plexus block, including epidural steroid injections or
             facet blocks, within 1 month prior to the screening visit.

          4. Patients with any other chronic pain condition that, in the investigator's opinion,
             would interfere with the assessment of low back pain (e.g., osteoarthritis, rheumatoid
             arthritis, postherpetic neuralgia, pain associated with diabetic neuropathy, migraine
             headaches requiring opioid therapy).

          5. Patients who are involved in an active workman's compensation or insurance claim or
             disability claim or litigation related to back pain.

          6. Patients who have by history used any illicit drugs of abuse, abused opioids or
             exhibited drug seeking behavior within 5 years prior to the screening visit.

          7. Patients who have abused prescription medication or alcohol within 5 years prior to
             the screening visit.

          8. Patients with a positive alcohol or drugs of abuse test

          9. Women who are pregnant (as indicated by a positive result in a serum pregnancy test
             administered at screening visit), or breast feeding, or planning to breast feed within
             30 days prior to the screening visit.

         10. Patients who have demonstrated allergic reactions or hypersensitivity to opioids.

         11. Patients who have had no bowel movement within three days, or bowel obstruction within
             60 days, prior to the screening visit.

         12. Patients with pre-existing severe narrowing of the gastrointestinal tract secondary
             to:

             prior gastrointestinal surgery (e.g., vagotomy, antrectomy, pyloroplasty,
             gastroplasty, gastrojejunostomy) or gastrointestinal disease resulting in impaired
             gastrointestinal function (e.g., paralytic ileus, gastroparesis, inflammatory bowel
             disease, "short gut" syndrome due to adhesions or decreased transit time, past history
             of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckel
             diverticulum)

         13. Patients who have a major psychiatric condition (e.g., schizophrenia, major
             depression) or who have clinically significant anxiety or depression as defined by a
             Hospital Anxiety and Depression Scale(HADS) score greater than 10.

         14. Patients who have received monoamine oxidase (MAO) inhibitors within 14 days prior to
             the screening visit.

         15. Patients with clinically significant abnormal laboratory results in clinical
             chemistry, hematology or urinalysis including serum glutamic-oxaloacetic
             transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic
             transaminase/alanine aminotransferase (ALT) ≥ 3.0 times the upper limit of the
             reference range or a serum creatinine ≥ 2.0 mg/dL at screening.

         16. Patients with a serious or unstable intercurrent illness.

         17. Patients with a history of uncontrolled seizure disorder.

         18. Patients with increased intracranial pressure, mental clouding of unknown etiology,
             coma, or hypotension.

         19. Patients who have severe asthma, severe chronic obstructive pulmonary disease, or any
             other disorder that predisposes the patient to carbon dioxide retention or respiratory
             depression.

         20. Patients who have taken any investigational drug within 30 days prior to the screening
             visit or are currently enrolled in another investigational drug study.