Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Arm, Multicenter Study in Subjects With End-Stage Joint Disease to Compare the Frequency of Constipation Symptoms in SubjectsTreated With Tapentadol IR and Oxycodone IR Using a Bowel Function Patient Diary
Brief Summary: The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
* Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
* Have a pain intensity \>4 on Numerical Rating Scale

Exclusion Criteria:

* Life-long history of seizure disorder or epilepsy
* Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
* Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
* History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
* Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
B: Inclusion Criteria:

* Either sex aged 65 or above
* Diagnosis of OA of the hip and/or knee
* Severe pain requiring step two medication
* Taking maximum dose of paracetamol

Exclusion Criteria:

* Painful disease of the joints other than OA
* Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
* Subjects taking cyclooxygenase (COX) II selective inhibitors
C: Inclusion Criteria:

* A clinical diagnosis of osteoarthritis of the hip or knee
* End-stage degenerative joint disease
* Eligibility for primary unilateral total or partial joint replacement surgery
* Pain level moderate to severe and at such a level as to require daily doses of an opioid analgesic medication

Exclusion Criteria:

* Has a life-long history of seizure disorder or epilepsy
* Had any of the following within the preceding 1 year: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
* Had a severe traumatic brain injury within 15 years of screening (consisting of one or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting for more than 24 hours)
* Joint pain not associated with gout, fibromyalgia, rheumatoid arthritis, other autoimmune disease
* History of alcohol or drug abuse
* chronic hepatitis B and C or HIV, active hepatitis B and C within 3 months
* Severely impaired renal function or moderately to severely impaired hepatic function
* History of cancer within past 2 years
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