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

NCT00771758 | Completed Phase 3 Results

• 2 other identifiers: CR015064KF5503/40
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Back Pain

Keywords

Vertebral compression fracture; Osteoporosis; Acute pain; Analgesic; Oxycodone; Tapentadol

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference Over 3 Days (SPID72)

  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.

  3 Days (72 hours)

Secondary Outcomes (44)

• 30% Responder Rate on Day 3.

  Day 3

• 50% Responder Rate on Day 3.

  Day 3

• 30% Responder Rate on Day 5.

  Day 5

• 50% Responder Rate on Day 5.

  Day 5

• 30% Responder Rate on Day 10.

  Day 10

Study Arms (3)

001

EXPERIMENTAL

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

002

EXPERIMENTAL

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

003

PLACEBO COMPARATOR

placebo 1 capsule every 4 - 6 hr as needed for up to 10 days

Drug: placebo

Interventions

oxycodone IR DRUG

maximum daily dose 450 mg

002

placebo DRUG

5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days

003

tapentadol IR DRUG

50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days

001

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead
• Grünenthal GmbH: collaborator

Study Sites (37)

Unknown Facility

Haleyville, Alabama, United States

Location

Unknown Facility

Tallassee, Alabama, United States

Location

Unknown Facility

Peoria, Arizona, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Encinitas, California, United States

Location

Unknown Facility

Los Gatos, California, United States

Location

Unknown Facility

Mission Viejo, California, United States

Location

Unknown Facility

Oakland, California, United States

Location

Unknown Facility

Roseville, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Studio City, California, United States

Location

Unknown Facility

Vista, California, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Kissimmee, Florida, United States

Location

Unknown Facility

Miami Springs, Florida, United States

Location

Unknown Facility

Ormond Beach, Florida, United States

Location

Unknown Facility

Saint Cloud, Florida, United States

Location

Unknown Facility

Vero Beach, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Gainesville, Georgia, United States

Location

Unknown Facility

Peachtree, Georgia, United States

Location

Unknown Facility

Savannah, Georgia, United States

Location

Unknown Facility

Valdosta, Georgia, United States

Location

Unknown Facility

Bloomington, Illinois, United States

Location

Unknown Facility

South Bend, Indiana, United States

Location

Unknown Facility

Covington, Louisiana, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

North Massapequa, New York, United States

Location

Unknown Facility

Hickory, North Carolina, United States

Location

Unknown Facility

Akron, Ohio, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Marion, Ohio, United States

Location

Unknown Facility

Eugene, Oregon, United States

Location

Unknown Facility

Aiken, South Carolina, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Mesquite, Texas, United States

Location

MeSH Terms

Conditions

Back Pain; Osteoporosis; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Insufficient number of participants enrolled to meet proposed sample size, so that statistical inferences could not be made.

Results Point of Contact

• Title: Senior Director of Clinical Development, Pain
• Organization: Ortho-McNeil Janssen Scientific Affair, LLC.

(908)927-5465

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 9, 2014
• Results First Posted: April 7, 2011

Record last verified: 2014-04

Locations

US (37)