Trial Outcomes & Findings for Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy (NCT NCT02815709)

NCT ID: NCT02815709

Last Updated: 2020-09-25

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

418 participants

Primary outcome timeframe

48 hours

Results posted on

2020-09-25

Participant Flow

Pre-Surgical Entry Criteria

Participant milestones

Participant milestones
Measure	Treatment 1 Oliceridine Oliceridine 0.1 mg	Treatment 2 Oliceridine Oliceridine 0.35 mg	Treatment 3 Oliceridine Oliceridine 0.5 mg	Placebo Placebo	Morphine Morphine
Overall Study STARTED	82	86	82	84	84
Overall Study Treated With Study Medication	76	79	79	79	76
Overall Study COMPLETED	75	78	75	76	74
Overall Study NOT COMPLETED	7	8	7	8	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment 1 Oliceridine n=76 Participants Oliceridine 0.1 mg	Treatment 2 Oliceridine n=79 Participants Oliceridine 0.35 mg	Treatment 3 Oliceridine n=79 Participants Oliceridine 0.5 mg	Placebo n=79 Participants Placebo	Morphine n=76 Participants Morphine	Total n=389 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=99 Participants	73 Participants n=107 Participants	75 Participants n=206 Participants	76 Participants n=7 Participants	70 Participants n=31 Participants	363 Participants n=30 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants	6 Participants n=107 Participants	4 Participants n=206 Participants	3 Participants n=7 Participants	6 Participants n=31 Participants	26 Participants n=30 Participants
Age, Continuous	47.5 years STANDARD_DEVIATION 12.65 • n=99 Participants	43.6 years STANDARD_DEVIATION 13.91 • n=107 Participants	46.9 years STANDARD_DEVIATION 13.81 • n=206 Participants	44.1 years STANDARD_DEVIATION 12.58 • n=7 Participants	43.3 years STANDARD_DEVIATION 14.13 • n=31 Participants	45.1 years STANDARD_DEVIATION 13.48 • n=30 Participants
Sex: Female, Male Female	64 Participants n=99 Participants	65 Participants n=107 Participants	66 Participants n=206 Participants	70 Participants n=7 Participants	65 Participants n=31 Participants	330 Participants n=30 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	14 Participants n=107 Participants	13 Participants n=206 Participants	9 Participants n=7 Participants	11 Participants n=31 Participants	59 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=99 Participants	25 Participants n=107 Participants	19 Participants n=206 Participants	17 Participants n=7 Participants	18 Participants n=31 Participants	96 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=99 Participants	54 Participants n=107 Participants	60 Participants n=206 Participants	62 Participants n=7 Participants	58 Participants n=31 Participants	293 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized White	47 participants n=99 Participants	56 participants n=107 Participants	61 participants n=206 Participants	56 participants n=7 Participants	50 participants n=31 Participants	270 participants n=30 Participants
Race/Ethnicity, Customized Black or African American	22 participants n=99 Participants	17 participants n=107 Participants	13 participants n=206 Participants	21 participants n=7 Participants	21 participants n=31 Participants	94 participants n=30 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=99 Participants	0 participants n=107 Participants	2 participants n=206 Participants	0 participants n=7 Participants	1 participants n=31 Participants	4 participants n=30 Participants
Race/Ethnicity, Customized Asian	4 participants n=99 Participants	4 participants n=107 Participants	1 participants n=206 Participants	1 participants n=7 Participants	4 participants n=31 Participants	14 participants n=30 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=99 Participants	1 participants n=107 Participants	2 participants n=206 Participants	0 participants n=7 Participants	0 participants n=31 Participants	4 participants n=30 Participants
Race/Ethnicity, Customized Other	1 participants n=99 Participants	1 participants n=107 Participants	0 participants n=206 Participants	1 participants n=7 Participants	0 participants n=31 Participants	3 participants n=30 Participants
Region of Enrollment United States	76 participants n=99 Participants	79 participants n=107 Participants	79 participants n=206 Participants	79 participants n=7 Participants	76 participants n=31 Participants	389 participants n=30 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: The analysis population reflects the number of patients treated with study medication.

Outcome measures

Outcome measures
Measure	Treatment 1 Oliceridine n=76 Participants Oliceridine 0.1 mg	Treatment 2 Oliceridine n=79 Participants Oliceridine 0.35 mg	Treatment 3 Oliceridine n=79 Participants Oliceridine 0.5 mg	Placebo n=79 Participants Placebo	Morphine n=76 Participants Morphine
Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.	38 Participants	49 Participants	52 Participants	12 Participants	54 Participants

SECONDARY outcome

Timeframe: 48 hours

Population: The analysis population reflects the number of patients treated with study medication.

Outcome measures

Outcome measures
Measure	Treatment 1 Oliceridine n=76 Participants Oliceridine 0.1 mg	Treatment 2 Oliceridine n=79 Participants Oliceridine 0.35 mg	Treatment 3 Oliceridine n=79 Participants Oliceridine 0.5 mg	Placebo n=79 Participants Placebo	Morphine n=76 Participants Morphine
Number of Respiratory Safety Events Compared to Morphine.	1 Respiratory Safety Events	7 Respiratory Safety Events	11 Respiratory Safety Events	0 Respiratory Safety Events	14 Respiratory Safety Events

SECONDARY outcome

Timeframe: 48 hours

Population: The analysis population reflects the number of patients treated with study medication.

Outcome measures

Outcome measures
Measure	Treatment 1 Oliceridine n=76 Participants Oliceridine 0.1 mg	Treatment 2 Oliceridine n=79 Participants Oliceridine 0.35 mg	Treatment 3 Oliceridine n=79 Participants Oliceridine 0.5 mg	Placebo n=79 Participants Placebo	Morphine n=76 Participants Morphine
Duration of Respiratory Safety Events Compared to Morphine.	2.21 hours Standard Error 1.796	3.44 hours Standard Error 1.186	3.34 hours Standard Error 0.797	2.94 hours Standard Error 1.074	5.14 hours Standard Error 1.060

SECONDARY outcome

Timeframe: 48 hours

Population: The analysis population reflects the number of patients treated with study medication. The morphine and placebo Arms/Groups are not included, as this is a comparison of study medication against morphine.

Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure.

Outcome measures

Outcome measures
Measure	Treatment 1 Oliceridine n=76 Participants Oliceridine 0.1 mg	Treatment 2 Oliceridine n=79 Participants Oliceridine 0.35 mg	Treatment 3 Oliceridine n=79 Participants Oliceridine 0.5 mg	Placebo Placebo	Morphine Morphine
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.	1.5 odds ratio	2.54 odds ratio	2.89 odds ratio	—	—

SECONDARY outcome

Timeframe: 48 hours

Population: The analysis population reflects the number of patients treated with study medication.