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Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
This study has been completed.

First Received on October 10, 2008.   Last Updated on March 10, 2011   History of Changes
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: oxycodone IR
Drug: placebo
Drug: tapentadol IR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Oxycodone hydrochloride Tapentadol
U.S. FDA Resources

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

Primary Outcome Measures:
  • Sum of Pain Intensity Difference Over 3 Days (SPID72) [ Time Frame: 3 Days (72 hours) ] [ Designated as safety issue: No ]

    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.

    The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.



Secondary Outcome Measures:
  • 30% Responder Rate on Day 3. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).

  • 50% Responder Rate on Day 3. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).

  • 30% Responder Rate on Day 5. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).

  • 50% Responder Rate on Day 5. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).

  • 30% Responder Rate on Day 10. [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).

  • 50% Responder Rate on Day 10. [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).

  • Sum of Pain Intensity Difference Over 2 Days (SPID48) [ Time Frame: 2 Days (48 hours) ] [ Designated as safety issue: No ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.

  • Sum of Pain Intensity Difference Over 5 Days (SPID120) [ Time Frame: 5 Days (120 hours) ] [ Designated as safety issue: No ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.

  • Sum of Pain Intensity Difference Over 10 Days [ Time Frame: 10 Days (216 Hours) ] [ Designated as safety issue: No ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.

  • Total Pain Relief (TOTPAR) Over 2 Days [ Time Frame: 2 Days (48 Hours) ] [ Designated as safety issue: No ]
    Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.

  • Total Pain Relief (TOTPAR) Over 3 Days [ Time Frame: 3 Days (72 Hours) ] [ Designated as safety issue: No ]
    Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.

  • Total Pain Relief (TOTPAR) Over 5 Days [ Time Frame: 5 Days (120 Hours) ] [ Designated as safety issue: No ]
    Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.

  • Total Pain Relief (TOTPAR) Over 10 Days [ Time Frame: 10 Days (216 Hours) ] [ Designated as safety issue: No ]
    Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.

  • Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days [ Time Frame: 2 Days ] [ Designated as safety issue: No ]
    The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.

  • Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.

  • Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
    The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.

  • Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
    The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.

  • Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.

  • Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.

  • Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.

  • Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

    The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.

    Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.


  • Summary of Subject Satisfaction With Treatment on Day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

  • Summary of Subject Satisfaction With Treatment on Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

  • Summary of Subject Satisfaction With Treatment on Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

  • Summary of Subject Satisfaction With Treatment on Day 10 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

  • Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via Interactive Voice Response (IVR) system in the morning.

  • Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via IVR system in the morning.

  • Sleep Quality - Shift From Baseline to End of Study (Placebo) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via IVR system in the morning.

  • Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

  • Patient Global Impression of Change (PGIC) at End of Study [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.

  • Clinician Global Impression of Change (CGIC) at End of Study [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.

  • Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = "not at all" to 5="a very great deal."

  • Summary of Clinician Ease-of-Care at the End of Study: Bothersome [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = "not at all" to 5="a very great deal."


Enrollment: 108
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
tapentadol IR 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days maximum daily dose 450 mg
 Drug: tapentadol IR
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days
Experimental: 002
oxycodone IR 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days maximum daily dose 60 mg
 Drug: oxycodone IR
maximum daily dose 450 mg
Placebo Comparator: 003
placebo 1 capsule every 4 - 6 hr as needed for up to 10 days
 Drug: placebo
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days

  Show Detailed Description

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

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: Senior Director, Clinical Development, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00771758     History of Changes
Other Study ID Numbers: CR015064, KF5503/40
Study First Received: October 10, 2008
Results First Received: December 8, 2010
Last Updated: March 10, 2011
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:
Back Pain
Osteoporosis
Fractures, Compression
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
 Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 24, 2012



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