Phase 3
Completed N=116
Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain
Source: ClinicalTrials.gov NCT00594516 ↗Enrolled (actual)
116
Serious AEs
1.7%
Results posted
Jul 2010
Primary outcomePrimary: The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences) — 0.1 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences) |
0.1 | — |
| SECONDARY The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment |
24 | — |
| SECONDARY The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment |
29 | — |
| SECONDARY Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period |
331.0 | — |
| SECONDARY Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period. |
330.4 | — |
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 =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)
Data sourced from ClinicalTrials.gov (NCT00594516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.