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

Condition(s) targeted: Low Back Pain

Intervention: Tapentadol; CG5503 ER (extended release) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated 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).

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

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline of the average pain intensity over the last week of the Maintenance period at Week 12 or over the entire 12-week Maintenance period, depending on country requirements.

Secondary outcome: Changes from baseline of the Brief Pain Inventory (BPI) pain interference score, pain subscales and total scores; Sleep Questionnaires (SQ) items; patient global impression of change (PGIC); time of treatment discontinuation due to lack of efficacy.

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 controlled trial is to evaluate the efficacy and safety of orally administered CG5503 Extended Release (ER) (base) at doses 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back. The study is being conducted for registration and approval of CG5503 in the US and outside US. The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level) , maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation). The study hypothesis is that the study drug will be more effective than placebo in reducing patients' pain intensity. The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification. The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase. This will be done by looking at the patient's pain diary information.

Titrate CG5503 ER (extended release) in 50 mg steps to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 20mg to 50mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with or without food, for a maximum timeframe of 15 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: February 2007
Last updated: February 7, 2008