Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis - Full Text View

Sponsor:	Ortho-McNeil Janssen Scientific Affairs, LLC
Collaborator:	Grünenthal GmbH
Information provided by:	Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00771758

Purpose

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.

Condition	Intervention	Phase
Back Pain	Drug: placebo Drug: oxycodone IR Drug: tapentadol IR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo- and Oxycodone Immediate Release (IR)-Controlled Study of Tapentadol IR for the Treatment of Acute Pain Caused by Vertebral Compression Fractures Associated With Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Fractures Osteoporosis

Drug Information available for: Oxycodone Tapentadol Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:

The primary endpoint is the sum of pain intensity difference over 72 hours [ Time Frame: sum of pain intensity difference over 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary endpoints: 30% and 50% responder rate; total pain relief over 2, 3, 5, and 10 days; sum of pain intensity difference over 2, 5, and 10 days; sleep quality, patient satisfaction, functionality, and physical performance and adverse events [ Time Frame: 30% and 50% responder rates; total pain relief over Days 2, 3, 5, and 10 days; sum of pain intensity difference over 2, 5, and 10 days; sleep quality, patient satisfaction, functionality, and physical performance; adverse events30% and 50% responder rate ] [ Designated as safety issue: No ]

Estimated Enrollment:	625
Estimated Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
003: Experimental placebo 1 capsule q4 - 6 hr prn for up to 10 days	Drug: placebo 1 capsule q4 - 6 hr prn for up to 10 days
001: Experimental tapentadol IR 50 or 75 mg capsule q4 - 6 hr prn for up to 10 days; max daily dose 450 mg	Drug: tapentadol IR 50 or 75 mg capsule q4 - 6 hr prn for up to 10 days; max daily dose 450 mg
002: Experimental oxycodone IR 5 or 10 mg capsule q4 - 6 hr prn for up to 10 days; max daily dose 60 mg	Drug: oxycodone IR 5 or 10 mg capsule q4 - 6 hr prn for up to 10 days; max daily dose 60 mg

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Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771758

Contacts

Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email

info1@veritasmedicine.com

Show 53 Study Locations

Sponsors and Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

Grünenthal GmbH

Investigators

Study Director:

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Ortho-McNeil Janssen Scientific Affairs, LLC

More Information

No publications provided

Responsible Party:	Ortho-McNeil Janssen Scientific Affairs, LLC ( Senior Director, Clinical Development )
Study ID Numbers:	CR015064, KF5503/40
Study First Received:	October 10, 2008
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00771758 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Vertebral compression fracture
Osteoporosis
Acute pain

Analgesic
Oxycodone
Tapentadol

Additional relevant MeSH terms:

Fractures, Compression
Fractures, Bone
Oxycodone
Physiological Effects of Drugs
Disorders of Environmental Origin
Pain
Bone Diseases
Signs and Symptoms
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Analgesics, Opioid

Nervous System Diseases
Wounds and Injuries
Osteoporosis
Central Nervous System Depressants
Bone Diseases, Metabolic
Narcotics
Back Pain
Pharmacologic Actions
Osteoporosis, Postmenopausal
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010