Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain
CompletedPhase 3NCT00594516
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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 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.
Study details
- Official title
- A Randomized, Double-Blind, 2-Period, Crossover Study to Establish the Dose Equivalence and Direct Conversion Between Immediate Release (IR) and Extended-Release (ER) CG5503 in Subjects With Moderate-to-Severe, Chronic Low Back Pain
- Conditions
- Interventions
- Drug: tapentadol (CG5503) Immediate Release IR
- Drug: tapentadol (CG5503) Extended Release (ER)
- Drug: tapentadol (CG5503) Immediate Release (IR)
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Collaborators
- GrĂ¼nenthal GmbH
- Start date
- 2007-12
- Primary completion
- 2008-04
- 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: * 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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00594516