Acute PainPhase 3APOLLO-1NCT02815709

Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

A Phase 3 study testing Oliceridine and Morphine in people with Acute Pain, run by Trevena Inc. at 7 sites in United States.

Completed

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

Official record

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Trial summary

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Acute Pain
What is being tested?: Oliceridine and Morphine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 418 participants
Where: 7 sitesUnited States
Study dates: May 2016to Jan 2017
Phase: Phase 3
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
Healthy volunteers accepted
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 moderate to severe acute pain.
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

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Research Site
Anaheim, California, 92801
Research Site
Austin, Texas, 78229
Research Site
Pasadena, California, 91105
Research Site
Pasadena, Maryland, 21122
Research Site
Phoenix, Arizona, 85027
Resarch Site
Salt Lake City, Utah, 84124
Research Site
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

Conditions: Acute Pain
Being tested: Oliceridine, Placebo, Morphine
Medical subject headings: Acute Pain

What participants receive

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

OliceridineDrug
PlaceboDrug
MorphineDrug

Study groups in NCT02815709
Study group	Role	What they receive
Treatment 1 Oliceridine	Experimental	Not described Receives: Drug: Oliceridine
Treatment 2 Oliceridine	Experimental	Not described Receives: Drug: Oliceridine
Treatment 3 Oliceridine	Experimental	Not described Receives: Drug: Oliceridine
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Morphine	Active comparator	Not described Receives: Drug: Morphine

What is being measured

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

Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
Measured: 48 hours

Secondary outcomes (4)

Number of Respiratory Safety Events Compared to Morphine.
Measured: 48 hours
Duration of Respiratory Safety Events Compared to Morphine.
Measured: 48 hours
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure.
Measured: 48 hours
Number of Patients With Treatment-related Adverse Events.
Measured: 48 hours

Timeline

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

May 2016Jan 2017

First posted28 Jun 2016 (estimated)
Study startMay 2016
Primary completionDec 2016
Study completionJan 2017

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 418 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02815709
Sponsor's protocol ID: CP130-3001
Acronym: APOLLO-1
Status last verified: Sep 2020
First submitted: 12 May 2016
Last updated: 25 Sep 2020
Results posted: Yes, on ClinicalTrials.gov

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 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
ClinicalTrials.gov ID: NCT02815709
Acronym / sponsor ID: APOLLO-1 / CP130-3001
Conditions: Acute Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 418 participants (actual)
Lead sponsor: Trevena Inc.Industry (pharma, biotech, devices)
Study start: May 2016
Primary completion: Dec 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 28 Jun 2016 (estimated)
Results: Posted 25 Sep 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Treatment 1 Oliceridine	Experimental	Drug: Oliceridine
Treatment 2 Oliceridine	Experimental	Drug: Oliceridine
Treatment 3 Oliceridine	Experimental	Drug: Oliceridine
Placebo	Placebo comparator	Drug: Placebo
Morphine	Active comparator	Drug: Morphine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: 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 moderate to severe acute pain.
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
Oliceridine	Drug	Treatment 1 Oliceridine, Treatment 2 Oliceridine, Treatment 3 Oliceridine
Placebo	Drug	Placebo
Morphine	Drug	Morphine

Primary outcome

Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
Time frame: 48 hours

4 secondary outcomes

Number of Respiratory Safety Events Compared to Morphine.
Time frame: 48 hours
Duration of Respiratory Safety Events Compared to Morphine.
Time frame: 48 hours
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
Time frame: 48 hours
Number of Patients With Treatment-related Adverse Events.
Time frame: 48 hours

Results and safety

Results posted to the registry on 25 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
Treatment 1 Oliceridine	82	75
Treatment 2 Oliceridine	86	78
Treatment 3 Oliceridine	82	75
Placebo	84	76
Morphine	84	74

Primary outcome: Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.

Time frame: 48 hours. Count of participants. Unit: Participants

Measure	Treatment 1 Oliceridine n = 76	Treatment 2 Oliceridine n = 79	Treatment 3 Oliceridine n = 79	Placebo n = 79	Morphine n = 76
Value	38	49	52	12	54

Population analysed: The analysis population reflects the number of patients treated with study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment 1 Oliceridine	0 of 76 (0%)	56 of 76 (73.7%)	0 of 76
Treatment 2 Oliceridine	0 of 79 (0%)	68 of 79 (86.1%)	0 of 79
Treatment 3 Oliceridine	0 of 79 (0%)	72 of 79 (91.1%)	0 of 79
Placebo	0 of 79 (0%)	54 of 79 (68.4%)	0 of 79
Morphine	0 of 76 (0%)	73 of 76 (96.1%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Pain

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Human Experimental Models of Pain (HEMP)
Acute Pain
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REctus Sheath Trial
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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
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oliceridine and Morphine in people with Acute Pain, run by Trevena Inc. at 7 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 25 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 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 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?

Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to 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 NCT02815709.

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 25 Sep 2020.