A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy
|ClinicalTrials.gov Identifier: NCT00455520|
Recruitment Status : Completed
First Posted : April 3, 2007
Results First Posted : January 13, 2010
Last Update Posted : July 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy||Drug: CG5503 Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||395 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of CG5503 Extended Release (ER) in Subjects With Painful Diabetic Peripheral Neuropathy|
|Study Start Date :||April 2007|
|Primary Completion Date :||August 2008|
|Study Completion Date :||August 2008|
Placebo Comparator: Placebo
placebo matching placebo twice daily for 12 weeks
matching placebo twice daily for 12 weeks
CG5503 100, 150, 200, 250mg twice daily given for up to 15 weeks
100, 150, 200, 250 mg twice daily given for up to 15 weeks
- Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12 [ Time Frame: Baseline and 12 weeks ]For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
- The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period. [ Time Frame: Start of Open Label and at 12 weeks of Double Blind ]The number of patients achieving at least 30% improvement in pain score at Week 12 of the double-blind maintenance period on an 11-point numerical rating scale compared with the start of the open-label period.
- Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 [ Time Frame: 12 week endpoint ]Percentage of patients who reported very much improved (1) or much improved (2) based on an ordinal measure indicating change from start of double blind treatment (on a scale of 7 = Very much worse to 1 = Very much improved)
- Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12 [ Time Frame: 12 week endpoint (change from baseline) ]Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
- Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. [ Time Frame: Baseline and 12 week endpoint ]A Sleep Questionnaire addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time (hours) indicates improvement.
- Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. [ Time Frame: Baseline and12 week endpoint ]Total pain score where zero equals "no pain" to ten equals "pain as bad as you can imagine" from 12 week endpoint vs baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455520
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|