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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), multicenter, double-blind (neither the
      patient nor the physician know the study drug administered) study to determine the efficacy
      and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in
      approximately 625 patients with acute pain caused by vertebral compression fractures (VCFs)
      associated with assumed osteoporosis for whom treatment with oral opioid analgesics is
      appropriate. Patients will be randomized to receive multiple doses of tapentadol IR 50 or 75
      milligrams (mg) or oxycodone IR 5 or 10 mg or placebo for up to 10 days.
      Screening/Randomization Visit (Visit 1): Potential patients with acute thoracolumbar pain
      with either new onset of pain or acute exacerbation of previous pain associated with a VCF
      will be identified. The acute pain episode must have started within 14 days of Visit 1. The
      study will be explained and informed consent will be obtained. Patients will either have had
      a radiographic procedure to confirm diagnosis of a VCF within 3 months prior to Visit 1 or
      will have a radiographic procedure (e.g., lateral vertebral x-ray or magnetic resonance
      imaging, etc) performed at Visit 1 as standard of care. Patients must have moderate to severe
      acute vertebral pain and must be appropriate candidates for pain management with an oral
      opioid analgesic. At Visit 1, patients must report both a qualifying average back pain
      intensity score in the last 24 hours related to the current episode and a qualifying current
      back pain intensity on an 11-point numerical rating scale (NRS) where 0=no pain and 10=pain
      as bad as you can imagine. Patients must also have a qualifying score on the Mini-Mental
      State Examination (MMSE) to be eligible for study participation. At Visit 1, patients will
      have laboratory assessments (including a urine drug screen), physical and back examinations
      and an electrocardiogram (ECG). Patients will also complete paper copies of the sleep
      quality, functionality and vomiting assessments (i.e., morning (AM) and evening (PM)
      Interactive Voice Response [IVR] system questions except satisfaction with treatment). In
      addition, patients will have physical performance assessed. Patients who have taken
      long-acting or controlled-release opioid therapy or immediate release CII opioid formulations
      (e.g., Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid) within the 1 month prior to
      Visit 1 are not eligible for the study. Patients taking a CIII opioid formulation (e.g.,
      Tylenol with Codeine) or any other analgesic medication (e.g., Non-steroidal
      anti-inflammatory drugs (NSAIDs) not previously described above will be eligible for study
      participation if they meet all study criteria (e.g., pain intensity score), unless they take
      the CIII > 5 days/week in the 1 month prior to Visit 1. After randomization all analgesic
      medications other than the study drug are prohibited except for NSAIDs taken for a condition
      other than chronic back pain, provided the patient has been taking a stable regimen for at
      least one month before screening and plans to continue throughout the study. Patients may
      take up to 2 pills (any form) of acetaminophen (e.g., Tylenol Extra-Strength) for pain other
      than back pain (e.g., headache, joint pain) once per day only. Subjects who take up to 325
      mg/day aspirin for cardiovascular prevention will be permitted to enter the study provided
      they are on a stable dose for at least 1 month prior to study entry and plan to continue the
      same dose during the study. Double-Blind Treatment: Patients may be enrolled and randomized
      with laboratory and ECG results pending. If the results of any of these tests suggest the
      patient is not in good health, the patient will immediately be discontinued from the study.
      Patients meeting study entry criteria will be randomized in a double-blind fashion in a 2:2:1
      ratio to receive tapentadol IR, oxycodone IR, or matching placebo every 4-6 hours during
      waking hours as needed for pain. The first dose of study drug will be one capsule of
      tapentadol IR 50 mg, oxycodone IR 5 mg or placebo. Most patients will take the first dose of
      study drug in the office at Visit 1. All patients will be instructed to call the IVR system
      to complete another assessment of current back pain intensity immediately before taking the
      first dose of study drug. This call will be made by the patient from the study site unless
      the first dose cannot be taken in the office, in which case the patient will make the call
      from home. Patients will be instructed to call the IVR system every morning and each evening
      to complete assessments related to back pain intensity and pain relief. Patients will also
      respond to IVR system questions related to sleep quality, patient satisfaction with treatment
      and functionality (AM only) and vomiting (PM only). Patients who discontinue prematurely for
      any reason will be instructed to contact the study site to complete final assessments, prior
      to taking supplemental pain medication if applicable, and to schedule a final study visit.
      During this call, site personnel will obtain current pain intensity and pain relief scores
      from the patient; these scores will be documented. Patients will begin treatment on Day 1
      with one "lower dose" capsule of study drug (tapentadol IR 50 mg, oxycodone IR 5 mg, or
      matching placebo). For subsequent doses, patients may remain at the "lower dose" capsule
      (tapentadol IR 50 mg, oxycodone IR 5 mg, or matching placebo) or may choose to take the
      "higher dose" (tapentadol IR 75 mg, oxycodone IR 10 mg, or matching placebo) every 4 to 6
      hours during waking hours as needed depending on their level of pain and tolerability of the
      study drug. The duration of treatment with study drug will be up to 10 days. Tapentadol IR
      450 mg or oxycodone IR 60 mg is the maximum daily dose allowed. Patients who require
      supplemental medication for insufficient analgesia will be discontinued from the study and
      will be treated at the investigator's discretion. All patients will receive a telephone call
      from the study staff on Day 3. During this telephone call, site personnel will inquire about
      the patient's overall status. Patients will return to the study site on Day 10/End of Study
      for the final visit (Visit 2). Patients who have not discontinued from the study prior to the
      final visit will complete a final assessment of current pain intensity and pain relief (on
      paper). In addition, all patients will have physical functionality assessed. Patients and
      investigators will each complete a global assessment of study drug. The investigator will
      also respond to two ease-of-care questions. Vital signs will be obtained, safety assessments
      will be completed and study drug will be collected. All patients will have their post-study
      analgesia prescribed at the investigator's discretion. Tapentadol IR 50 or 75 mg, oxycodone
      IR 5 or 10 mg, or placebo for up to 10 days. The dose is every 4-6 hours, as needed for pain.
      Maximum dosage is 450 mg tapentadol or 60 mg oxycodone per day.
    

Intervention name(s): oxycodone IR; placebo; tapentadol IR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vertebral compression fracture; Osteoporosis; Acute pain; Analgesic; Oxycodone; Tapentadol