PainPhase 2NCT02520297

A Pilot Study of TRV130 for the Treatment of Fracture Pain

A Phase 2 study testing TRV130 in people with Pain, run by Trevena Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain
What is being tested?: TRV130
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 20 Oct 2015to 23 Oct 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-65 years, inclusive
Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity
Able to understand and comply with study procedures and requirements, and provide written informed consent

Who cannot join

Significant concomitant head, chest, or abdominal trauma
Multiple extremity trauma
Open fracture
Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, 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

Trial locations and contacts

1 site in 1 country.

United States1 site

Trevena, Inc.
Indianapolis, Indiana

Other trials in United States

About this study

Official title: A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture

Read the detailed description

This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.

Conditions: Pain
Being tested: TRV130
Keywords: Pain, Long bone, Fracture
Medical subject headings: Pain, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRV130Drug
Drug

Study groups in NCT02520297
Study group	Role	What they receive
TRV130	Experimental	Drug: TRV130 Receives: Drug: TRV130

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Measured: 3-hours

Secondary outcomes (3)

Time Weighted Average Change in NPRS
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Measured: From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours
Time to First NPRS <= 3
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Measured: 3-hours
Safety Assessments
Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.
Measured: 3-hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 201523 Oct 2015

First posted11 Aug 2015 (estimated)
Study start20 Oct 2015
Primary completion23 Oct 2015
Study completion23 Oct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02520297
Sponsor's protocol ID: CP130-2004
Status last verified: Aug 2020
First submitted: 7 Aug 2015
Last updated: 7 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture
ClinicalTrials.gov ID: NCT02520297
Acronym / sponsor ID: CP130-2004
Conditions: Pain
Keywords: Pain, Long bone, Fracture
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 1 participants (actual)
Lead sponsor: Trevena Inc.Industry (pharma, biotech, devices)
Collaborators: Kestrel Biologic
Study start: 20 Oct 2015 (actual)
Primary completion: 23 Oct 2015 (actual)
Study completion: 23 Oct 2015 (actual)
First posted: 11 Aug 2015 (estimated)
Results: Posted 7 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TRV130	Experimental	Drug: TRV130Drug: TRV130

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18-65 years, inclusive
Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity
Able to understand and comply with study procedures and requirements, and provide written informed consent

Key exclusion criteria (4 listed)

Significant concomitant head, chest, or abdominal trauma
Multiple extremity trauma
Open fracture
Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRV130Drug	Drug	TRV130

Primary outcome

Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.
Time frame: 3-hours
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

3 secondary outcomes

Time Weighted Average Change in NPRS
Time frame: From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours
Time to First NPRS <= 3
Time frame: 3-hours
Safety Assessments
Time frame: 3-hours

Results and safety

Results posted to the registry on 7 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRV130	1	1

Primary outcome: Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.

Time frame: 3-hours

Population analysed: Study terminated early. Primary outcome not measured.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRV130	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Study terminated early due to lack of enrollment. Analyses for the primary and secondary outcomes were not completed. No mortalities, serious adverse events, or adverse events were reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Indiana University principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TRV130 in people with Pain, run by Trevena Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication. (time frame: 3-hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02520297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.