NCT02100748

Brief Summary

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
333

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

March 23, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
6 years until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

March 23, 2014

Results QC Date

August 20, 2020

Last Update Submit

September 11, 2020

Conditions

Acute Pain

Keywords

moderate to severe acute painbunionectomy

Outcome Measures

Primary Outcomes (1)

  • Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo

    Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.

    48 hours

Study Arms (6)

TRV130 1 mg

EXPERIMENTAL

TRV130 1 mg IV Q4H x 48 h

Drug: TRV130

TRV130 2 mg

EXPERIMENTAL

TRV130 2 mg IV Q4H x 48 h

Drug: TRV130

TRV130 3 mg

EXPERIMENTAL

TRV130 3 mg IV Q4H x 48 h

Drug: TRV130

TRV130 4 mg

EXPERIMENTAL

TRV130 4 mg IV Q4H x 48 h

Drug: TRV130

Morphine

ACTIVE COMPARATOR

Morphine 4 mg IV Q4H x 48 h

Drug: Morphine

Placebo

PLACEBO COMPARATOR

Placebo (D5W) IV Q4H x 48 h

Drug: Placebo

Interventions

TRV130DRUG

TRV130 1 - 4 mg will be administered every 4 hours

TRV130 1 mgTRV130 2 mgTRV130 3 mgTRV130 4 mg
MorphineDRUG

Morphine 4 mg will be administered every 4 hours

Also known as: Morphine sulphate
Morphine
PlaceboDRUG

Placebo will be administered every 4 hours

Also known as: Dextrose 5% in water, D5W
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
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 ≥ 4 on an 11 point NRS
  • 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 (4)

Premier Research

Phoenix, Arizona, 85027, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Premier Research

Austin, Texas, 78705, United States

Location

Jean Brown Research

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))amineMorphineGlucoseWater

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 CompoundsHexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen 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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2014

First Posted

April 1, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 16, 2020

Results First Posted

September 16, 2020

Record last verified: 2020-09

Locations

US(4)