Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain
Low Back Pain
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Dose Equivalence, Tapentadol (CG5503), Tapentadol-IR, Tapentadol-ER
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Low Back Pain (LBP) of non-malignant origin present for at least 3 months immediately before study entry
- Taking drug treatment for pain for at least 3 months before screening and who are dissatisfied with current therapy
- Subjects receiving opioid treatment must have a total daily opioid dose <= 160 mg/day of oral morphine equivalent
- For entry into open label period patients must have a baseline score >=5 on an 11-point NRS, calculated as the average pain intensity during the last 3 days of the washout period
- For entry into the double-blind period subjects must have remained on the same optimal stable dose and frequency of tapentadol (CG5503) IR administration during the last 3 days of the open-label treatment period
Exclusion Criteria:
- Presence of conditions other than Low Back Pain (LBP) that could make it hard to assess or self-evaluate pain
- Surgery in low back area within 3 months of screening or expected surgery in the low back area during the study
- Any scheduled surgery or painful procedure during the study, or any clinically significant disease that, in the opinion of the investigator, may affect efficacy or safety assessments
- History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been treated and is no longer present
- Women who are pregnant or breast-feeding
- Moderately or severely impaired liver function
- Severely impaired kidney function
- History of chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C in past 3 months
- History of seizure disorder
- Alcohol or drug abuse
- Uncontrolled high blood pressure
- Clinically relevant history of hypersensitivity, allergy, or contraindications to acetaminophen or opioid analgesics (or ingredients)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
001
002
tapentadol (CG5503) Immediate Release (IR) Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100 150 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second,tapentadol (CG5503) Immediate Release IR 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period
tapentadol (CG5503) Extended Release (ER) During 2 double blind periods: Tapentadol ER 100 150 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second