PainPhase 2NCT02335294

A Study of TRV130 for the Treatment of Pain After Abdominoplasty

A Phase 2 study testing TRV130 and Morphine in people with Pain, run by Trevena Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty. 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 and Morphine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 2 sitesUnited States
Study dates: Dec 2014to Aug 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

>=18 and <=65 years of age.
Plans to undergo an abdominoplasty procedure with no additional collateral procedures.
Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Houston, Texas, 77024
Study site
Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty

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

Read the detailed description

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

Conditions: Pain
Being tested: TRV130, Morphine, Placebo
Keywords: Pain, abdominoplasty, PCA
Medical subject headings: Pain

What participants receive

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

TRV130Drug
Rescue: Ibuprofen, oxycodone
MorphineDrug
Also called Morphine sulphate
Rescue: Ibuprofen, oxycodone
PlaceboDrug
Also called Dextrose 5% in water, D5W
Rescue: Ibuprofen, oxycodone

Study groups in NCT02335294
Study group	Role	What they receive
TRV130	Experimental	Not described Receives: Drug: TRV130
Morphine	Active comparator	Not described Receives: Drug: Morphine
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 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 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
Measured: 24-hours

Secondary outcomes (1)

Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine
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 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
Measured: 24-hours

Timeline

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

Dec 2014Aug 2015

First posted9 Jan 2015 (estimated)
Study startDec 2014
Primary completionJul 2015
Study completionAug 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02335294
Sponsor's protocol ID: CP130-2002
Status last verified: Sep 2020
First submitted: 7 Jan 2015
Last updated: 16 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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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty
ClinicalTrials.gov ID: NCT02335294
Acronym / sponsor ID: CP130-2002
Conditions: Pain
Keywords: Pain, abdominoplasty, PCA
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Trevena Inc.Industry (pharma, biotech, devices)
Collaborators: Lotus Clinical Research, LLC
Study start: Dec 2014
Primary completion: Jul 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 9 Jan 2015 (estimated)
Results: Posted 16 Sep 2020

Clinical summary

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

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TRV130	Experimental	Drug: TRV130
Morphine	Active comparator	Drug: Morphine
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (3 listed)

>=18 and <=65 years of age.
Plans to undergo an abdominoplasty procedure with no additional collateral procedures.
Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.

Key exclusion criteria (4 listed)

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.

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
TRV130Rescue: Ibuprofen, oxycodone	Drug	TRV130
MorphineAlso: Morphine sulphateRescue: Ibuprofen, oxycodone	Drug	Morphine
PlaceboAlso: Dextrose 5% in water, D5WRescue: Ibuprofen, oxycodone	Drug	Placebo

Primary outcome

Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo
Time frame: 24-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 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.

1 secondary outcome

Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine
Time frame: 24-hours

Results and safety

Results posted to the registry on 16 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
Protocol v1-4 TRV130 0.1 mg	39	36
Protocol v1-4 Morphine	42	38
Protocol v1-4 Placebo	19	18
Protocol v5 TRV130 0.35 mg	39	36
Protocol v5 Morphine	41	39
Protocol v5 Placebo	20	19

Primary outcome: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo

Time frame: 24-hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Protocol v1-4 TRV130 0.1 mg n = 39	Protocol v1-4 Placebo n = 19	Protocol v5 TRV130 0.35 mg n = 39	Protocol v5 Placebo n = 20
Value	-3.8 (2.53)	-1.7 (2.26)	-3.5 (2.32)	-1.2 (2.93)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Protocol v1-4 TRV130 0.1 mg	0 of 39 (0%)	26 of 39 (66.7%)	0 of 39
Protocol v1-4 Morphine	0 of 42 (0%)	39 of 42 (92.9%)	0 of 42
Protocol v1-4 Placebo	0 of 19 (0%)	8 of 19 (42.1%)	0 of 19
Protocol v5 TRV130 0.35 mg	0 of 39 (0%)	32 of 39 (82.1%)	0 of 39
Protocol v5 Morphine	1 of 41 (2.4%)	39 of 41 (95.1%)	0 of 41
Protocol v5 Placebo	0 of 20 (0%)	16 of 20 (80%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites 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 and Morphine in people with Pain, run by Trevena Inc. at 2 sites 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: finished, as of the sponsor's last update on 16 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 2 sites 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. Some participants in this study may receive a placebo. 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 16 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?

Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo (time frame: 24-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 NCT02335294.

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 16 Sep 2020.