A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
CompletedPhase 3NCT00449176
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain
- Conditions
- Interventions
- Drug: tapentadol (CG5503) ER
- Drug: oxycodone CR
- Drug: placebo
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Collaborators
- Grünenthal GmbH
- Start date
- 2007-02
- Primary completion
- 2008-05
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00449176