A Study of TRV130 for the Treatment of Pain After Bunionectomy
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TRV130
Morphine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring moderate to severe acute pain, bunionectomy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Premier Research
- Chesapeake Research Group
- Premier Research
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
TRV130 1 mg
TRV130 2 mg
TRV130 3 mg
TRV130 4 mg
Morphine
Placebo
Arm Description
TRV130 1 mg IV Q4H x 48 h
TRV130 2 mg IV Q4H x 48 h
TRV130 3 mg IV Q4H x 48 h
TRV130 4 mg IV Q4H x 48 h
Morphine 4 mg IV Q4H x 48 h
Placebo (D5W) IV Q4H x 48 h
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02100748
Brief Title
A Study of TRV130 for the Treatment of Pain After Bunionectomy
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Multiple-dose, Adaptive, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain After Bunionectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevena Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
moderate to severe acute pain, bunionectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRV130 1 mg
Arm Type
Experimental
Arm Description
TRV130 1 mg IV Q4H x 48 h
Arm Title
TRV130 2 mg
Arm Type
Experimental
Arm Description
TRV130 2 mg IV Q4H x 48 h
Arm Title
TRV130 3 mg
Arm Type
Experimental
Arm Description
TRV130 3 mg IV Q4H x 48 h
Arm Title
TRV130 4 mg
Arm Type
Experimental
Arm Description
TRV130 4 mg IV Q4H x 48 h
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Morphine 4 mg IV Q4H x 48 h
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (D5W) IV Q4H x 48 h
Intervention Type
Drug
Intervention Name(s)
TRV130
Intervention Description
TRV130 1 - 4 mg will be administered every 4 hours
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine sulphate
Intervention Description
Morphine 4 mg will be administered every 4 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dextrose 5% in water, D5W
Intervention Description
Placebo will be administered every 4 hours
Primary Outcome Measure Information:
Title
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Skobieranda, MD
Organizational Affiliation
Trevena Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Premier Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Chesapeake Research Group
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Premier Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of TRV130 for the Treatment of Pain After Bunionectomy
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