- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02100748
A Study of TRV130 for the Treatment of Pain After Bunionectomy
September 11, 2020 updated by: Trevena Inc.
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
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
333
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85027
- Premier Research
-
-
Maryland
-
Pasadena, Maryland, United States, 21122
- Chesapeake Research Group
-
-
Texas
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Austin, Texas, United States, 78705
- Premier Research
-
-
Utah
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Salt Lake City, Utah, United States, 84124
- Jean Brown Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TRV130 1 mg
TRV130 1 mg IV Q4H x 48 h
|
TRV130 1 - 4 mg will be administered every 4 hours
|
Experimental: TRV130 2 mg
TRV130 2 mg IV Q4H x 48 h
|
TRV130 1 - 4 mg will be administered every 4 hours
|
Experimental: TRV130 3 mg
TRV130 3 mg IV Q4H x 48 h
|
TRV130 1 - 4 mg will be administered every 4 hours
|
Experimental: TRV130 4 mg
TRV130 4 mg IV Q4H x 48 h
|
TRV130 1 - 4 mg will be administered every 4 hours
|
Active Comparator: Morphine
Morphine 4 mg IV Q4H x 48 h
|
Morphine 4 mg will be administered every 4 hours
Other Names:
|
Placebo Comparator: Placebo
Placebo (D5W) IV Q4H x 48 h
|
Placebo will be administered every 4 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo
Time Frame: 48 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
March 23, 2014
First Submitted That Met QC Criteria
March 27, 2014
First Posted (Estimate)
April 1, 2014
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 11, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP130-2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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