Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
Condition: Back Pain
MeSH terms: Osteoporosis; Acute Pain; Fractures, Compression
Intervention: oxycodone IR; placebo; tapentadol IR
Intervention description: maximum daily dose 450 mg; 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Vertebral compression fracture; Osteoporosis; Acute pain; Analgesic; Oxycodone; Tapentadol

Summary:

      The purpose of this study is to determine the effectiveness and safety of tapentadol
      immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain
      caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom
      treatment with oral opioid analgesics is appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female (non-pregnant, non-lactating) and male

          -  new onset of pain or acute exacerbation of previous pain associated with a VCF within
             14 days prior to Visit 1

          -  Radiographic confirmation of a VCF within 3 months prior to Visit 1 or a radiographic
             procedure performed at Visit 1

          -  Average back pain intensity score in the last 24 hours related to the current episode
             and a qualifying current back pain intensity score

          -  Qualifying score on the Mini-Mental Status Exam

          -  Able to verbalize and differentiate with regard to location and intensity of pain

          -  Medically stable

          -  Sexually active women must be postmenopausal for at least 1 year, surgically sterile,
             or practicing an effective method of birth control at study entry and throughout the
             trial

          -  Women of childbearing potential must have a negative urine pregnancy test at Visit 1

          -  Physically and mentally willing and able to adhere to the protocol requirements and
             its prohibitions and restrictions

          -  Sign an informed consent document

        Exclusion Criteria:

          -  Neurological symptoms or deficits, or radiculopathy related to the VCF

          -  Taken any of the following in the month before Visit 1: long-acting or
             controlled-release opioid, immediate release Class II opioid formulations or Class III
             opioid formulation (e.g., Tylenol with Codeine) > 5 days/week

          -  Systemic steroid therapy within 3 months before Visit 1

          -  Anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants,
             neuroleptics, or serotonin norepinephrine reuptake inhibitor within 2 weeks before
             randomization

          -  Major trauma to or infection in the fractured vertebrae in the 6 months preceding
             study

          -  Pain due to herniated nucleus pulposus, high energy trauma, severe spinal stenosis,
             bone tumor at the level(s) of pathology or known canal compromise causing clinical
             manifestations of cord, neural foramen, or nerve root compression with an ongoing pain
             level of >= 5

          -  Severe cardiopulmonary deficiencies

          -  Active systemic or local infection

          -  History of alcohol or drug abuse in the investigator's judgment based on medical
             history and physical examination

          -  Malignancy within the past 2 years, with the exception of basal cell carcinoma

          -  Concomitant autoimmune inflammatory conditions

          -  History of laboratory values reflecting severe renal insufficiency

          -  History of moderately or severely impaired hepatic function or alanine
             aminotransaminase or aspartate aminotransferase greater than 3 times the upper limit
             of normal.