Skip to content

An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain

CompletedPhase 3NCT00487435
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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.

Study details

Official title
Open-Label Extension, Single-Arm, Flexible-Dosing, Phase 3 Trial With CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain
Interventions
  • Drug: Tapentadol (CG5503) Extended Release (ER)
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
GrĂ¼nenthal GmbH
Start date
2007-06
Primary completion
2009-06
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Australia, Canada, New Zealand, United States
Total sites listed
148

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Canadian sites (23)

Canadian sites for NCT00487435HalifaxChilliwackKelownaPentictonVancouverSt. John'sAjaxBrampton
Canadian sites for NCT00487435. 22 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00487435