Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.
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|ClinicalTrials.gov Identifier: NCT03108482|
Recruitment Status : Completed
First Posted : April 11, 2017
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Post-surgical Pain||Drug: Co-crystal E-58425 (Tramadol/Celecoxib) Drug: Tramadol (Ultram®) Drug: Celecoxib (Celebrex®) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||637 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind, Active- (Tramadol and Celecoxib) and Placebo-controlled, Parallel Groups, Phase 3 Clinical Trial to Establish the Efficacy of Co-crystal E-58425 for the Management of Moderate to Severe Post-surgical Pain After Bunionectomy.|
|Actual Study Start Date :||March 14, 2017|
|Actual Primary Completion Date :||November 9, 2017|
|Actual Study Completion Date :||November 28, 2017|
Experimental: Co-crystal E-58425 (Tramadol/Celecoxib)
Co-crystal E-58425 (Tramadol/Celecoxib): Two tablets of 100 mg every 12 hours. The total daily dose will be 400 mg of Co-crystal E-58425.
Drug: Co-crystal E-58425 (Tramadol/Celecoxib)
Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours.
Active Comparator: Tramadol (Ultram®)
Tramadol: One tablet of 50 mg every 6 hours. The total daily dose will be 200 mg of tramadol.
Drug: Tramadol (Ultram®)
Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.
Active Comparator: Celecoxib (Celebrex®)
Celecoxib: One capsule of 100 mg every 12 hours. The total daily dose will be 200 mg of celecoxib.
Drug: Celecoxib (Celebrex®)
Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours.
Placebo Comparator: Placebo
Placebo: One or two tablets of 100 mg every 6 hours.
Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours.
- Sum of Pain Intensity Differences (SPID) [ Time Frame: Assessments was recorded from time 0 to 48 hours. ]The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Pain Rating Scale (NPRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain". The primary analysis endpoint was the Sum of Pain Intensity Differences (SPID) from 0 to 48 hours. Pain Intensity Differences (PID) was the difference between current PI at assessment minus baseline PI (prior to the first dose). Baseline PI ranged from 5 to 9. SPID was calculated as a time-weighted Sum of PID scores over 48 hours. Negative differences correspond to an amelioration of pain, while positive differences correspond to recrudescence of pain. The observed SPID score ranged from -139.12 to -74.55 for SPID-48 being the total score range from -480 (best) to +480 (worst). A higher negative value of SPID indicates greater pain relief.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108482
|United States, Arizona|
|Arizona Research Center|
|Phoenix, Arizona, United States, 85023|
|United States, California|
|Anaheim Clinical Trials, LLC|
|Anaheim, California, United States, 92801|
|United States, Maryland|
|Chesapeake Research Group, LLC|
|Pasadena, Maryland, United States, 21122|
|United States, Texas|
|Optimal Research, LLC|
|Austin, Texas, United States, 78705|
|United States, Utah|
|Jean Brown Research|
|Salt Lake City, Utah, United States, 84124|
|Study Director:||Jesus Cebrecos, MD, MBA||Laboratorios del Dr. Esteve, S.A.|
|Study Chair:||Michael Kuss||Premier Research Group plc|
|Principal Investigator:||Ira J Gottlieb, DPM||Chesapeake Research Group, LLC|