Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opioid-Naïve Patients With Chronic Low Back Pain
Brief Summary: The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in non-cancer patients with chronic low back pain.


Options:
A: 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.
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:

* Males or females 18 years of age or older
* opioid naïve
* Have an initial pain intensity score of at least 50 mm VAS
* In good health as determined by the investigator on the basis of medical history and physical examination
* Have moderate to severe chronic non-neuropathic LBP that has been present daily for at least several hours per day for a minimum of three months prior to the Screening
* Any adjunct therapy for back pain such as physical therapy, biofeedback therapy, acupuncture therapy or herbal remedies, based on the patient's current status should remain unchanged during the period of participation of the patient
* Written informed consent

Exclusion Criteria:

* Pregnant and/or lactating
* Radiculopathy, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, severe lower extremity weakness or numbness, bowel or bladder dysfunction secondary to cauda equina compression, diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection or tumor
* Cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, or inhalation analgesia). The patient must not have a nerve/plexus block within 4 weeks of screening
* Intend to alter physical therapy regimen during the study.
* Surgical procedures directed towards the source of back pain within 6 months of screening
* Pain which is secondary to confirmed or suspected neoplasm
* Dysphagia or difficulty swallowing tablets or capsules, or an inability to take oral medication
* Significant prior history of substance abuse or alcohol abuse
* Use of any investigational medication within 30 days prior to the first dose of study medication
* Previous exposure to oxymorphone
* History of clinically significant intolerance to oxymorphone or a known hypersensitivity to opioid analgesics
* History of seizure
* Ileostomy or colostomy
* Use of MAO inhibitor within 14 days prior to the start of study medication
* Other clinically significant conditions as judged by the investigator
D: 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

Answer: C