Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Variable-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release OROS® Hydromorphone HCl (NMED-1077) Compared to Placebo in Patients With Chronic Low Back Pain
Brief 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.


Options:
A: 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.
B: Inclusion Criteria:

* Patients who have chronic non-malignant pain, including pain associated with AIDS, who are currently receiving strong oral or transdermal opioid analgesics, or patients who are currently receiving opioids plus non-opioid combination analgesics, and have persisting pain
* patients who require at least 45 mg of oral morphine or opioid equivalent every 24 hours for the management of chronic non-malignant pain
* patients who can reasonably be expected to have stable opioid requirements for the duration of the study.

Exclusion Criteria:

* Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
* patients who have dysphagia or are unable to swallow tablets
* patients who are pregnant or breast-feeding
* patients with severe respiratory compromise or severely depressed ventilatory function
* patients with any gastrointestinal disorder, including pre-existing severe GI narrowing(pathologic or iatrogenic), that may affect the absorption or transit of orally administered drugs or have an acute abdominal condition that may be obscured by opioids
* patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
* patients who are known active drug abusers or alcoholics
* patients with any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
C: Inclusion Criteria:

* A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months
* require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder
* post-washout baseline pain intensity score \>4 on an 11-point numerical rating scale

Exclusion Criteria:

* History of seizure disorder or epilepsy
* uncontrolled hypertension
* currently treated with monoamine oxidase inhibitors
* systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening
* history of malignancy within the past 2 years, with the exception of basal cell carcinoma
D: Inclusion Criteria:

* Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
* Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \<5 mg oxycodone (or equivalent) per day,
* Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy

Exclusion Criteria:

* Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
* Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
* Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion criteria may apply.

Answer: A