Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Collaborator: Grünenthal GmbH
• Treatments: Oxycodone; Tapentadol

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.