A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain
2 other identifiers
interventional
1,123
2 countries
52
Brief Summary
The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2006
CompletedFirst Posted
Study publicly available on registry
August 8, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
September 4, 2009
CompletedApril 29, 2014
April 1, 2014
1.7 years
August 4, 2006
July 24, 2009
April 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAE)
The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
52 weeks
Secondary Outcomes (1)
Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)
Baseline, Week 52
Study Arms (2)
Tapentadol (CG5503)
EXPERIMENTALTapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year.
Oxycodone
ACTIVE COMPARATOROxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
Interventions
Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.
Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
- Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
- Have a pain intensity \>4 on Numerical Rating Scale
You may not qualify if:
- Life-long history of seizure disorder or epilepsy
- Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
- Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
- History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
- Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Cudahy, California, United States
Unknown Facility
Encinitas, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Westlake Village, California, United States
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
Chiefland, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Oldsmar, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Cumming, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Perry, Georgia, United States
Unknown Facility
Suwanee, Georgia, United States
Unknown Facility
Woodstock, Georgia, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Paducah, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Rockville, Maryland, United States
Unknown Facility
Wellesley Hills, Massachusetts, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Mamaroneck, New York, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Roanoke, Virginia, United States
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Coquitlam, British Columbia, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Corunna, Ontario, Canada
Unknown Facility
Greater Sudbury, Ontario, Canada
Unknown Facility
Mississauga, Ontario, Canada
Unknown Facility
Sarnia, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Vancouver, Ontario, Canada
Unknown Facility
Pointe-Claire, Quebec, Canada
Unknown Facility
Trois-Rivières, Quebec, Canada
Unknown Facility
Saskatoon, Saskatchewan, Canada
Related Publications (3)
Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2.
PMID: 24985410DERIVEDAfilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.
PMID: 23340531DERIVEDWild JE, Grond S, Kuperwasser B, Gilbert J, McCann B, Lange B, Steup A, Haufel T, Etropolski MS, Rauschkolb C, Lange R. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010 Sep-Oct;10(5):416-27. doi: 10.1111/j.1533-2500.2010.00397.x.
PMID: 20602712DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Leader
- Organization
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2006
First Posted
August 8, 2006
Study Start
November 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
April 29, 2014
Results First Posted
September 4, 2009
Record last verified: 2014-04