Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
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|ClinicalTrials.gov Identifier: NCT02820324|
Recruitment Status : Completed
First Posted : June 30, 2016
Results First Posted : October 23, 2020
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: Oliceridine Drug: Placebo Drug: Morphine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||407 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
|Experimental: Treatment 1 Oliceridine||
|Experimental: Treatment 2 Oliceridine||
|Experimental: Treatment 3 Oliceridine||
|Placebo Comparator: Treatment 4 Placebo||
|Active Comparator: Treatment 5 Morphine||
- Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. [ Time Frame: 24 hours ]The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.
- Number of Respiratory Safety Events Compared to Morphine. [ Time Frame: 24 hours ]Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
- Duration of Respiratory Events Compared to Morphine. [ Time Frame: 24 hours ]Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
- Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine. [ Time Frame: 24 hours ]Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure.
- Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine. [ Time Frame: 24 hours ]
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): NCT02820324
|United States, Arizona|
|Phoenix, Arizona, United States, 85027|
|United States, California|
|Pasadena, California, United States, 91105|
|United States, Maryland|
|Pasadena, Maryland, United States, 21122|
|United States, Texas|
|Houston, Texas, United States, 77027|
|San Antonio, Texas, United States, 78229|
|Study Director:||Franck Skobieranda, MD||Trevena Inc.|