An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
Open-Label Extension, Single-Arm, Flexible-Dosing, Phase 3 Trial With CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain
3 other identifiers
interventional
1,166
4 countries
148
Brief Summary
The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characterize adverse events and tolerability, sleep quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall impression of change; and characterize patient-related health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Jun 2007
Typical duration for phase_3 pain
148 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
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
July 23, 2010
CompletedMay 9, 2014
April 1, 2014
2 years
June 14, 2007
June 24, 2010
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Treatment-emergent Adverse Events (TEAE)
The number of subjects 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, 52 weeks
Study Arms (1)
001
EXPERIMENTALTapentadol (CG5503) Extended Release (ER) 100 150 200 250 mg oral tablet twice daily for 52 weeks
Interventions
100, 150, 200, 250 mg oral tablet twice daily for 52 weeks
Eligibility Criteria
You may qualify if:
- Non-lactating female subjects (Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control \[e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization\] before entry and throughout the trial. Female patients of childbearing potential must have a negative pregnancy test at screening.)
- Completion of the expected double-blind treatment period of the pivotal Tapentadol (CG5503) Phase 3 trials in osteoarthritis (R331333-PAI-3008, KF5503/11) or low back pain (R331333-PAI-3011, KF5503/23), or completion of the 1-year treatment period of the safety CG5503 Phase 3 trial in the non-European sites (R331333-PAI-3007, KF5503/24)
- Must be willing to take Tapentadol (CG5503) extended release (ER) and the rescue medication supplied for the duration of the trial
You may not qualify if:
- History of alcohol and/or drug abuse, life-long history of seizure disorder or epilepsy, any of the following within the past year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
- Severe traumatic brain injury within the past 15 years
- Uncontrolled hypertension (repeated systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg)
- Severely impaired renal function
- Moderately or severely impaired hepatic function
- Patients taking neuroleptics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Hoover, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Encinitas, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Huntington Park, California, United States
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
Los Gatos, California, United States
Unknown Facility
Pico Rivera, California, United States
Unknown Facility
Pismo Beach, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Westlake Village, California, United States
Unknown Facility
Stamford, Connecticut, United States
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
Chiefland, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Hallandale, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Kissimmee, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Oldsmar, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Tamarac, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Athens, Georgia, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Perry, Georgia, United States
Unknown Facility
Suwanee, Georgia, United States
Unknown Facility
Woodstock, Georgia, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Avon, Indiana, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Valparaiso, Indiana, United States
Unknown Facility
West Des Moines, Iowa, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Madisonville, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Lake Charles, Louisiana, United States
Unknown Facility
Mandeville, Louisiana, United States
Unknown Facility
Metairie, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Columbia, Maryland, United States
Unknown Facility
Owings Mills, Maryland, United States
Unknown Facility
Rockville, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Brighton, Massachusetts, United States
Unknown Facility
Fall River, Massachusetts, United States
Unknown Facility
North Dartmouth, Massachusetts, United States
Unknown Facility
Wellesley Hills, Massachusetts, United States
Unknown Facility
West Yarmouth, Massachusetts, United States
Unknown Facility
East Lansing, Michigan, United States
Unknown Facility
Grand Blanc, Michigan, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Troy, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Cherry Hill, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Mamaroneck, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Greensboro, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Allentown, Pennsylvania, United States
Unknown Facility
Chester, Pennsylvania, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Morrisville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Prosperity, South Carolina, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Clarksville, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Amarillo, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Hurst, Texas, United States
Unknown Facility
Lubbock, Texas, United States
Unknown Facility
Odessa, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Danville, Virginia, United States
Unknown Facility
Roanoke, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
Unknown Facility
Bellevue, Washington, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Adelaide, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
Newcastle, Australia
Unknown Facility
Woodville North, Australia
Unknown Facility
Chilliwack, British Columbia, Canada
Unknown Facility
Kelowna, British Columbia, Canada
Unknown Facility
Penticton, British Columbia, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Ajax, Ontario, Canada
Unknown Facility
Brampton, Ontario, Canada
Unknown Facility
Greater Sudbury, Ontario, Canada
Unknown Facility
Kitchener, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Markham, Ontario, Canada
Unknown Facility
Mississauga, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Sarnia, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Vancouver, Ontario, Canada
Unknown Facility
Charlottetown, Prince Edward Island, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Pointe-Claire, Quebec, Canada
Unknown Facility
Saint Romuald, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Unknown Facility
Saskatoon, Saskatchewan, Canada
Unknown Facility
Halifax, Canada
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Tauranga, New Zealand
Unknown Facility
Wellington, New Zealand
Related Publications (1)
Buynak R, Rappaport SA, Rod K, Arsenault P, Heisig F, Rauschkolb C, Etropolski M. Long-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial. Clin Ther. 2015 Nov 1;37(11):2420-38. doi: 10.1016/j.clinthera.2015.08.014. Epub 2015 Oct 1.
PMID: 26428249DERIVED
Related Links
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 18, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
May 9, 2014
Results First Posted
July 23, 2010
Record last verified: 2014-04