NCT02815709

Brief Summary

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

May 12, 2016

Results QC Date

August 17, 2020

Last Update Submit

September 4, 2020

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.

    48 hours

Secondary Outcomes (4)

  • Number of Respiratory Safety Events Compared to Morphine.

    48 hours

  • Duration of Respiratory Safety Events Compared to Morphine.

    48 hours

  • Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.

    48 hours

  • Number of Patients With Treatment-related Adverse Events.

    48 hours

Study Arms (5)

Treatment 1 Oliceridine

EXPERIMENTAL
Drug: Oliceridine

Treatment 2 Oliceridine

EXPERIMENTAL
Drug: Oliceridine

Treatment 3 Oliceridine

EXPERIMENTAL
Drug: Oliceridine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Morphine

ACTIVE COMPARATOR
Drug: Morphine

Interventions

OliceridineDRUG
Treatment 1 OliceridineTreatment 2 OliceridineTreatment 3 Oliceridine
PlaceboDRUG
Placebo
MorphineDRUG
Morphine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
  • Experiences a pain intensity rating of moderate to severe acute pain.
  • Able to provide written informed consent before any study procedure.

You may not qualify if:

  • ASA Physical Status Classification System classification of P3 or worse.
  • Has surgical or post-surgical complications.
  • Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • Has previously participated in another TRV130 clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Phoenix, Arizona, 85027, United States

Location

Research Site

Anaheim, California, 92801, United States

Location

Research Site

Pasadena, California, 91105, United States

Location

Research Site

Pasadena, Maryland, 21122, United States

Location

Research Site

Austin, Texas, 78229, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Resarch Site

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amineMorphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Kelly Arscott
Organization
Trevena, Inc.
karscott@trevena.com
6103548840

Study Officials

  • Franck Skobieranda, MD

    Trevena Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

June 28, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

September 25, 2020

Results First Posted

September 25, 2020

Record last verified: 2020-09

Locations

US(7)