Trial Outcomes & Findings for A Pilot Study of TRV130 for the Treatment of Fracture Pain (NCT NCT02520297)

NCT ID: NCT02520297

Last Updated: 2020-09-07

Results Overview

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

3-hours

Results posted on

2020-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	TRV130 Drug: TRV130
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of TRV130 for the Treatment of Fracture Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRV130 n=1 Participants Drug: TRV130
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-hours

Population: Study terminated early. Primary outcome not measured.

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours

Population: Study terminated early. Secondary outcome not measured.

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-hours

Population: Study terminated early. Secondary outcome not measured.

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-hours

Population: Study terminated early. Secondary outcome not measured.

Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.

Outcome measures

Outcome data not reported

Adverse Events

TRV130

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelly Arscott

Trevena, Inc.

Phone: 6103548840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER