Status:
COMPLETED
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice dail...
Detailed Description
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication), phase III, placebo and active co...
Eligibility Criteria
Inclusion
- Men and non-pregnant, non-lactating women having a diagnosis of Lower Back Pain (LBP) of non-malignant origin present for at least 3 months
- Patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
- Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to \< 160 mg of oral morphine
- Baseline score of =5 on an 11-point numerical rater scale, calculated as the average pain intensity during the last 3 days prior to randomization.
Exclusion
- History of alcohol and/or drug abuse in Investigator's judgement
- History of significant liver insufficiency
- chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months
- Life-long history of seizure disorder or epilepsy
- History of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
- Uncontrolled hypertension
- Patients with severely impaired renal function
- Patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
981 Patients enrolled
Trial Details
Trial ID
NCT00449176
Start Date
February 1 2007
End Date
May 1 2008
Last Update
April 30 2012
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