Acute PainPhase 2NCT02100748

A Study of TRV130 for the Treatment of Pain After Bunionectomy

A Phase 2 study testing TRV130 and Morphine in people with Acute Pain, run by Trevena Inc. at 4 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 after bunionectomy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acute Pain
What is being tested?: TRV130 and Morphine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 333 participants
Where: 4 sitesUnited States
Study dates: Apr 2014to Oct 2014
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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

4 sites in 1 country.

United States4 sites

Premier Research
Austin, Texas, 78705
Chesapeake Research Group
Pasadena, Maryland, 21122
Premier Research
Phoenix, Arizona, 85027
Jean Brown Research
Salt Lake City, Utah, 84124

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Acute Pain
Being tested: TRV130, Morphine, Placebo
Keywords: moderate to severe acute pain, bunionectomy
Medical subject headings: Acute Pain

What participants receive

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

TRV130Drug
TRV130 1 - 4 mg will be administered every 4 hours
MorphineDrug
Also called Morphine sulphate
Morphine 4 mg will be administered every 4 hours
PlaceboDrug
Also called Dextrose 5% in water, D5W
Placebo will be administered every 4 hours

Study groups in NCT02100748
Study group	Role	What they receive
TRV130 1 mg	Experimental	TRV130 1 mg IV Q4H x 48 h Receives: Drug: TRV130
TRV130 2 mg	Experimental	TRV130 2 mg IV Q4H x 48 h Receives: Drug: TRV130
TRV130 3 mg	Experimental	TRV130 3 mg IV Q4H x 48 h Receives: Drug: TRV130
TRV130 4 mg	Experimental	TRV130 4 mg IV Q4H x 48 h Receives: Drug: TRV130
Morphine	Active comparator	Morphine 4 mg IV Q4H x 48 h Receives: Drug: Morphine
Placebo	Placebo comparator	Placebo (D5W) IV Q4H x 48 h 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 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.
Measured: 48 hours

Timeline

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

Apr 2014Oct 2014

First posted1 Apr 2014 (estimated)
Study startApr 2014
Primary completionOct 2014
Study completionOct 2014

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 Acute 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02100748
Sponsor's protocol ID: CP130-2001
Status last verified: Sep 2020
First submitted: 23 Mar 2014
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Acute Pain
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REctus Sheath Trial
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A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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All Acute Pain trials

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, Multicenter, Randomized, Double-blind, Multiple-dose, Adaptive, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain After Bunionectomy
ClinicalTrials.gov ID: NCT02100748
Acronym / sponsor ID: CP130-2001
Conditions: Acute Pain
Keywords: moderate to severe acute pain, bunionectomy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 333 participants (actual)
Lead sponsor: Trevena Inc.Industry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 1 Apr 2014 (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 after bunionectomy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
TRV130 1 mg	Experimental	Drug: TRV130TRV130 1 mg IV Q4H x 48 h
TRV130 2 mg	Experimental	Drug: TRV130TRV130 2 mg IV Q4H x 48 h
TRV130 3 mg	Experimental	Drug: TRV130TRV130 3 mg IV Q4H x 48 h
TRV130 4 mg	Experimental	Drug: TRV130TRV130 4 mg IV Q4H x 48 h
Morphine	Active comparator	Drug: MorphineMorphine 4 mg IV Q4H x 48 h
Placebo	Placebo comparator	Drug: PlaceboPlacebo (D5W) IV Q4H x 48 h

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

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
TRV130TRV130 1 - 4 mg will be administered every 4 hours	Drug	TRV130 1 mg, TRV130 2 mg, TRV130 3 mg, TRV130 4 mg
MorphineAlso: Morphine sulphateMorphine 4 mg will be administered every 4 hours	Drug	Morphine
PlaceboAlso: Dextrose 5% in water, D5WPlacebo will be administered every 4 hours	Drug	Placebo

Primary outcome

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.

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
Part A - TRV130 1 mg	25	23
Part A - TRV130 2 mg	24	23
Part A - TRV130 3 mg	22	21
Part A - TRV130 4 mg	22	21
Part A - Morphine	25	23
Part A - Placebo	23	23
Part B - TRV130 0.5 mg	20	18
Part B - TRV130 1 mg	38	34
Part B - TRV130 2 mg	36	33
Part B - TRV130 3 mg	31	29
Part B - Placebo	28	26
Part B - Morphine	39	39

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

Time frame: 48 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Part A - TRV130 1 mg n = 25	Part A - TRV130 2 mg n = 24	Part A - TRV130 3 mg n = 22	Part A - TRV130 4 mg n = 22	Part A - Morphine n = 25	Part A - Placebo n = 23	Part B - TRV130 0.5 mg n = 20	Part B - TRV130 1 mg n = 38	Part B - TRV130 2 mg n = 36	Part B - TRV130 3 mg n = 31	Part B - Placebo n = 28	Part B - Morphine n = 39
Value	-3.1 (2.11)	-3.1 (2.25)	-2.6 (1.82)	-3.3 (1.51)	-4.1 (2.02)	-3.2 (1.79)	-3.0 (2.36)	-2.9 (2.64)	-3.7 (2.10)	-5.0 (2.14)	-2.8 (2.12)	-4.0 (1.89)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - TRV130 1 mg	0 of 25 (0%)	22 of 25 (88%)	0 of 25
Part A - TRV130 2 mg	0 of 24 (0%)	21 of 24 (87.5%)	0 of 24
Part A - TRV130 3 mg	0 of 22 (0%)	20 of 22 (90.9%)	0 of 22
Part A - TRV130 4 mg	0 of 22 (0%)	22 of 22 (100%)	0 of 22
Part A - Morphine	0 of 25 (0%)	23 of 25 (92%)	0 of 25
Part A - Placebo	0 of 23 (0%)	11 of 23 (47.8%)	0 of 23
Part B - TRV130 0.5 mg	0 of 20 (0%)	16 of 20 (80%)	0 of 20
Part B - TRV130 1 mg	0 of 38 (0%)	31 of 38 (81.6%)	0 of 38
Part B - TRV130 2 mg	0 of 36 (0%)	31 of 36 (86.1%)	0 of 36
Part B - TRV130 3 mg	0 of 31 (0%)	28 of 31 (90.3%)	0 of 31
Part B - Placebo	0 of 28 (0%)	20 of 28 (71.4%)	0 of 28
Part B - Morphine	0 of 39 (0%)	31 of 39 (79.5%)	0 of 39

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.

Related trials for Acute Pain

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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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.

Franck Skobieranda, MD study director

Trevena Inc.

4 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 Acute Pain, run by Trevena Inc. at 4 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 4 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 48 Hours Between TRV130 and Placebo (time frame: 48 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 NCT02100748.

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.