Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: tapentadol (CG5503) Immediate Release IR; tapentadol (CG5503) Extended Release (ER); tapentadol (CG5503) Immediate Release (IR)
Intervention description: 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; 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; 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
Intervention MeSH terms: Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low Back Pain; Dose Equivalence; Tapentadol (CG5503); Tapentadol-IR; Tapentadol-ER

Summary:

      The objective of this study is to test the idea that the immediate-release (IR) form of
      tapentadol (CG5503) can be directly converted into an approximately equivalent total daily
      dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and
      efficacy.
    

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)