Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

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

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.

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

Details

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

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)