The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
98
Teva Investigational Site 22
La Mesa, California, United States
Occurrence of adverse events compared to placebo
Time frame: throughout the 28-week double-blind treatment period
Mean change in the weekly average of daily average pain intensity (API) in the affected leg on the 11-Point Numerical Rating Scale (NRS-11)
The average pain intensity over the past 24 hours on the NRS-11 will be collected daily by electronic diary.
Time frame: at week 4 compared with baseline
Weekly average of daily leg API score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: at each of the first 6 weeks
Weekly average of daily back API score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: at each of the first 6 weeks
Weekly average of daily worst leg pain score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: at each of the first 6 weeks
Weekly average of daily worst back pain score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: at each of the first 6 weeks
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Teva Investigational Site 18
Laguna Hills, California, United States
Teva Investigational Site 19
Pasadena, California, United States
Teva Investigational Site 2
Pasadena, California, United States
Teva Investigational Site 14
Orlando, Florida, United States
Teva Investigational Site 5
Sarasota, Florida, United States
Teva Investigational Site 10
Marietta, Georgia, United States
Teva Investigational Site 13
Marietta, Georgia, United States
Teva Investigational Site 9
Bloomington, Illinois, United States
Teva Investigational Site 15
Overland Park, Kansas, United States
...and 14 more locations
Patients with 30% and 50% reductions in average pain over the previous 24 hours as measured by the Brief Pain Inventory Short Form (BPI-SF)
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: at 1, 2, 4, 6, 14, and 28 weeks
Change in total Oswestry Disability Index (ODI) score as well as subscale scores
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: at 1, 2, 4, 6, 14, and 28 weeks
Score on the Patient Global Impression of Change
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: at 1, 2, 4, 6, 14, and 28 weeks
Change in 36-Item Short Form Health Survey (SF-36) score
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: from baseline to weeks 4, 14, and 28
Average daily amount of rescue medication used
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: during each of the first 6 weeks of the 28-week double-blind treatment period
Patients requiring a subsequent injection of epidural steroids
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: up to 28 weeks after CEP-37247 treatment
Patients requiring back surgery
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Time frame: up to 28 weeks after CEP-37247 treatment
Evaluate the safety of CEP-37247 treatment as assessed by vital signs measurements
Time frame: at weeks 1, 2, 4, 6, 14, and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by electrocardiogram (ECG) results
Time frame: at week 4
Evaluate the safety of CEP-37247 treatment as assessed by clinical laboratory tests
Time frame: at weeks 1, 2, 4, 6, 14, and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by physical examination
Time frame: at weeks 4 and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by neurologic examination
Time frame: at weeks 1, 2, 4 and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by concomitant medication usage
Time frame: throughout the 28-week double-blind treatment period
Evaluate the safety of CEP-37247 treatment as assessed by immunogenicity tests
Time frame: at weeks 2, 4, 6, 14, and 28 (or early termination)
Characterize the serum pharmacokinetics of CEP-37247 following epidural administration
Time frame: Throughout the 28-week double-blind treatment period