Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Osteoarthritis, Hip
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-...
Detailed Description
Tapentadol (CG5503) is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study is a randomized (patients are assigned different treatments bas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1123 Patients enrolled
Trial Details
Trial ID
NCT00361504
Start Date
November 1 2006
End Date
July 1 2008
Last Update
April 29 2014
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Mesa, Arizona, United States
2
Tucson, Arizona, United States
3
Anaheim, California, United States
4
Cudahy, California, United States