A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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 daily in patients with moderate to severe chronic pain of the lower back, in comparison with placebo and Oxycodone Controlled Release (CR).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Grünenthal GmbH
• Treatments: Oxycodone; Tapentadol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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