PainPhase 3NCT02401750

A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery

A Phase 3 study testing Oxycodone Naltrexone (a) and Oxycodone Naltrexone (b) in people with Pain, run by Elite Laboratories, Inc at 5 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus Naltrexone Hydrochloride (b) in patients who have… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain
What is being tested?: Oxycodone Naltrexone (a) and Oxycodone Naltrexone (b)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 163 participants
Where: 5 sitesUnited States
Study dates: Jun 2015to Sep 2015
Phase: Phase 3
Are there results?: None posted in the registry

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

Complete the informed consent process as documented by a signed informed consent form (ICF).
Be in generally good health and classified as either PS-1 or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
Be male or female, age 18 to 75 years, inclusively at the time of screening.
Be scheduled for a primary, unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation (with no collateral procedures)
Female subjects are eligible only if all of the following apply:
Not pregnant (subjects of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening and a negative urine pregnancy test before surgery);

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Not lactating;
Not planning to become pregnant within the duration of study;
Surgically sterile (bilateral tubal ligation or hysterectomy), or at least two years postmenopausal, or is practicing an acceptable form of birth control (defined as the use of an intrauterine device [IUD], a barrier method with spermicide, condoms, any form of hormonal contraceptives, partner with a vasectomy (surgery at least 6 weeks prior to start of surgery) or abstinence ) for at least 3 months prior to the screening visit and agrees to continue acceptable methods of contraception until one week following the last dose of ELI-200.
Be willing to complete the pain assessments and return to clinic as scheduled.
Subjects must experience postoperative pain (Day 1) that is at least moderate as measured by a NRS score ≥ 4 on a 0-10 NRS, less than 9 hours after discontinuing the nerve block.

Who cannot join

Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study.
Have a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator.
Have had any type of gastric bypass surgery or have a gastric band. Have previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus.
Have a history of any medical condition or surgical procedure that would alter the absorption, distribution, metabolism or excretion of oxycodone or any opioid including but not limited to severe chronic diarrhea, chronic constipation, irritable bowel syndrome, or bowel resection.
Have a history of severe bronchial asthma, hypercarbia, or hypoxia (oxygen partial pressure [PO2] <92%) or any respiratory condition that, in the opinion of the investigator, makes the subject unsuitable for the study. Mild episodic asthma or exercised induced asthma will be allowed.
Have, in the opinion of the investigator, a clinically significant abnormality on their clinical laboratory values (urinalysis, hematology and chemistry) at screening.

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Have glycosylated hemoglobin (2c) > 7%.
Have Addison's disease, benign prostatic hyperplasia, or kidney disease or other conditions as outlined in the Investigator's Brochure or the Percocet and Oxycontin Package Inserts that are contraindicated for use.
Have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to Day -1 .
Have made a plasma donation within 7 days prior to Day -1.
Have a known allergy or hypersensitivity to any opioid analgesics, naltrexone, anesthetics (eg, propofol), acetaminophen, NSAIDs (eg, ibuprofen or naproxen, ketorolac) or any of the excipients
Have a known allergy or hypersensitivity to ropivacaine, Mepivacaine, Lidocaine or any related drug.
Have a history of significant intolerance (in the opinion of the investigator) or allergic hypersensitivity reaction to opioid use.
Not be willing to discontinue the prohibited medications, within the allotted time before surgery and throughout the duration of their participation in the study.
Have a history of substance(more than recreational use) or alcohol (more than 14 drinks in a week) abuse within 2 years before screening.
Have a positive drug screen or alcohol screen result.
Use of anti-coagulant agents (eg, Coumadin, heparin, etc)
Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
Have an active malignancy of any type, or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
Have dysphagia and/or cannot swallow study medication whole.
Use concurrent therapy that could interfere with the evaluation of efficacy or safety parameters in the opinion of the investigator. (eg, any drugs, in the investigators opinion, that may exert significant analgesic properties or act synergistically with oxycodone, morphine, ketorolac, acetaminophen or ibuprofen).
Have a history of seizures or history of serious head injury.
Must not be a member of a vulnerable population as defined by the Code of Federal Regulations Title 45, Part 46, Section 46.111(b), including but not limited to employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the Sponsor, or of the Clinical Research Organization.
Have previously participated in a clinical trial using (Oxycodone Hydrochloride Naltrexone Hydrochloride, 1.5 mg or Oxycodone Hydrochloride , Naltrexone Hydrochloride 3.0 mg ).
Have a history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study. Institutionalized subjects will not be eligible for participation.
Been exposed to any investigational agent within 30 days or five half-lives (whichever is longer) prior to check-in for Day 1, Period 1, or is scheduled to receive an investigational device or drug (other than test product) during the course of this study.
Day -1 Exclusions:
1. Have taken any of the following drugs within the indicated times before surgery:
over-the-counter or prescription non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen [Advil®, Motrin®]), acetaminophen, or naproxen sodium (Anaprox®, Aleve®) within 24 hours; a daily dose of 81 mg of aspirin will be allowed (higher doses must be lowered to 81 mg a day by 72 hours prior to surgery).
naproxen sodium sustained-release (Naprelan®) within 72 hours
C-2 inhibitors (such as piroxicam or indomethacin) within 5 days
oxycodone-containing drugs and other analgesic drugs containing opioids within the past 14 days
immediate-release sedating antihistamines, tranquilizers, or hypnotics within at least 6 hours, or long-acting or sustained-released forms of these drugs within at least 7 days of Day -1
Day 1 Exclusion:
1. Have surgical complications (Day -1) that could compromise the safety of the subject or confound the results of the trial or any other reason that, in the opinion of the investigator, makes the subject unsuitable to participate.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 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
Endeavor Clinial Trials
San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Multiple-dose, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Abuse-deterrent Capsules Oxycodone Hydrochloride Plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride Plus Naltrexone Hydrochloride (b) for the Treatment of Adults With Moderate to Severe Pain Following Bunionectomy Surgery

Read the detailed description

The study is designed to evaluate the safety and efficacy of oxycodone/naltrexone (a) and oxycodone/naltrexone (b) versus placebo. During the blinded phase of the study (inpatient portion) the dosing regimen is 1 capsule containing Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone plus Naltrexone Hydrochloride (b) or placebo taken with 4 to 6 ounces (oz) of water every 6 hours (q6h) for 48 hours following the first dose (Multiple-dose Period) while in-house. Then for the open-label phase of the study (outpatient portion) dosing will occur every 4 to 6 hours prn with Oxycodone plus naltrexone. The active and placebo study medications will appear identical. Study subjects with acute postoperative pain of moderate to severe intensity following unilateral bunionectomy surgery will be randomized after surgery, and will stay at the study center for the duration of the 48-hour double-blind period after dose 1 of study medication. The study will be conducted in the following 4 periods: 1) a pre-treatment period, 2) a multiple-dose inpatient period (double-blind), 3) a multiple-dose outpatient period (open-label), and 4) End of Study/Follow-up.

Conditions: Pain
Being tested: Oxycodone Naltrexone (a), Oxycodone Naltrexone (b), Placebo
Medical subject headings: Pain

What participants receive

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

Oxycodone Naltrexone (a)Drug
Oxycodone Naltrexone (b)Drug
PlaceboDrug
Matches both experimental drugs

Study groups in NCT02401750
Study group	Role	What they receive
Oxycodone Naltrexone (a)	Experimental	Double-Blind Oxycodone/Naltrexone, 1 capsule by mouth every 6 hours for 48 hours Receives: Drug: Oxycodone Naltrexone (a)
Oxycodone Naltrexone (b)	Experimental	Double-Blind Oxycodone/Naltrexone , 1 capsule by mouth every 6 hours for 48 hours Receives: Drug: Oxycodone Naltrexone (b)
Placebo	Placebo comparator	Double-Blind Placebo to experimental Oxycodone/Naltrexone, 1 capsule every 6 hours for 48 hours Receives: Drug: Placebo

What is being measured

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

Pain Intensity Measure for Oxycodone/Naltrexone (a)
Self reported pain intensity prior to 1st dose, every 30 minutes for the 1st 6 hours, immediately prior to each drug administration (every 6 hours) and at 2 hours after each drug administration. Each is scored 0-10 (0=no pain and 10 = worst pain imaginable) on a Likert Scale
Measured: Every 6 hours for 48 hours

Secondary outcomes (12)

Pain Intensity Measure for Oxycodone/Naltrexone (b)
Self reported pain intensity prior to 1st dose, every 30 minutes for the 1st 6 hours, immediately prior to each drug administration (every 6 hours) and at 2 hours after each drug administration. Each is scored 0-10 (0=no pain and 10 = worst pain imaginable) on a Likert Scale
Measured: Every 6 hours for 48 hours
Pain Relief Measure for Oxycodone/Naltrexone (a and b formulations)
Self reported pain relief, every 30 minutes for the 1st 6 hours, immediately prior to each drug administration (every 6 hours) and at 2 hours after each drug administration. Pain relief is scored on a 5 point scale of None, A Little, Some, A Lot and Complete Relief from the starting pain.
Measured: Every 6 hours for 48 hours
Number of Subjects with Changes in Physical Examination from Day 1 Pre-dose to End of Study
Changes in Physical Exam will be evaluated/analyzed from Day 1 Pre-dose to Day 8. Descriptive statistics will be used (number and percent of occurrences).
Measured: Pre-Dose Day 1 and Day 8
Number of Subjects with Changes in Pulse Oximetry from Pre-Dose to post-dose time points
Changes in Pulse Oximetry will be evaluated/analyzed from pre-dose to post-dose values. Descriptive statistics will be used (number and present of occurrences).
Measured: 48 hours (multiple time points) and at each out patient visit (Days 4, 6, 8)
Number of Subjects with Changes in Blood Chemistry Analytes from baseline to end of study
Changes in Blood Chemistry values at 48 hours post-dose and end of study will be evaluated/analyzed from baseline (screening) values. Descriptive statistics will be used (number and percent of occurrences).
Measured: Screening, 48 hours post-dose and Day 8
Number of Subjects with Changes in Hematology Analytes from baseline to end of study
Changes in Hematology values at 48 hours post-dose and end of study will be evaluated/analyzed. Descriptive statistics will be used (number and percent of occurrences).
Measured: Screening, 48 hours post-dose and Day 8
Number of Subjects with Changes in Urinalysis from baseline to end of study
Changes in Urinalysis at 48 hours post-dose and end of study will be evaluated/analyzed. Descriptive statistics will be used (number and percent of occurrences)
Measured: Screening, 48 hours post-dose and Day 8
Number of Subjects with Changes in Systolic Blood Pressure from baseline through multiple post-dose time points
Blood pressure will be done every 6 hours for the 1st 48 hours then at each outpatient visit. Descriptive statistics will be used (number and percent of occurrences) of changes from baseline to subsequent time points post-dose.
Measured: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of Subjects with Changes in Diastolic Blood Pressure from Baseline through multiple time points post-dose
Blood pressure will be done every 6 hours for the 1st 48 hours then at each outpatient visit. Descriptive statistics will be used (number and percent of occurrences) of changes from baseline to subsequent time points post-dose.
Measured: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of Subjects with Changes in Pulse Rate
Pulse rate will be measured every 6 hours for the 1st 48 hours then at each outpatient visit. Descriptive statistics will be used (number and percent of occurrences) of changes from baseline to subsequent time points post-dose.
Measured: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of Subjects with Changes in Respiratory Rate
Respiratory rate will be measured every 6 hours for the 1st 48 hours then at each outpatient visit. Descriptive statistics will be used (number and percent of occurrences) of changes from baseline to subsequent time points post-dose.
Measured: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Number of subjects that reported an Adverse Event will be reported by body system, severity, relatedness to study drug as number and percent of occurrences.
Measured: Day 1 through 7 days post last dose

Timeline

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

Jun 2015Sep 2015

First posted30 Mar 2015 (estimated)
Study startJun 2015
Primary completionJul 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02401750
Sponsor's protocol ID: ELI-003-2014
Status last verified: Aug 2016
First submitted: 18 Mar 2015
Last updated: 9 Aug 2016
Results posted: No
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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Multiple-dose, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Abuse-deterrent Capsules Oxycodone Hydrochloride Plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride Plus Naltrexone Hydrochloride (b) for the Treatment of Adults With Moderate to Severe Pain Following Bunionectomy Surgery
ClinicalTrials.gov ID: NCT02401750
Acronym / sponsor ID: ELI-003-2014
Conditions: Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: Elite Laboratories, IncIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Jul 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 30 Mar 2015 (estimated)
Results: Not posted in the source record

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Oxycodone Naltrexone (a)	Experimental	Drug: Oxycodone Naltrexone (a)Double-Blind Oxycodone/Naltrexone, 1 capsule by mouth every 6 hours for 48 hours
Oxycodone Naltrexone (b)	Experimental	Drug: Oxycodone Naltrexone (b)Double-Blind Oxycodone/Naltrexone , 1 capsule by mouth every 6 hours for 48 hours
Placebo	Placebo comparator	Drug: PlaceboDouble-Blind Placebo to experimental Oxycodone/Naltrexone, 1 capsule every 6 hours for 48 hours

Who may qualify

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

Key inclusion criteria (11 listed)

Complete the informed consent process as documented by a signed informed consent form (ICF).
Be in generally good health and classified as either PS-1 or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
Be male or female, age 18 to 75 years, inclusively at the time of screening.
Be scheduled for a primary, unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation (with no collateral procedures)
Female subjects are eligible only if all of the following apply:

Key exclusion criteria (35 listed)

Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study.
Have a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator.
Have had any type of gastric bypass surgery or have a gastric band. Have previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus.
Have a history of any medical condition or surgical procedure that would alter the absorption, distribution, metabolism or excretion of oxycodone or any opioid including but not limited to severe chronic diarrhea, chronic constipation, irritable bowel syndrome, or bowel resection.
Have a history of severe bronchial asthma, hypercarbia, or hypoxia (oxygen partial pressure [PO2] <92%) or any respiratory condition that, in the opinion of the investigator, makes the subject unsuitable for the study. Mild episodic asthma or exercised induced asthma will be allowed.

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
Oxycodone Naltrexone (a)	Drug	Oxycodone Naltrexone (a)
Oxycodone Naltrexone (b)	Drug	Oxycodone Naltrexone (b)
PlaceboMatches both experimental drugs	Drug	Placebo

Primary outcome

Pain Intensity Measure for Oxycodone/Naltrexone (a)
Time frame: Every 6 hours for 48 hours
Self reported pain intensity prior to 1st dose, every 30 minutes for the 1st 6 hours, immediately prior to each drug administration (every 6 hours) and at 2 hours after each drug administration. Each is scored 0-10 (0=no pain and 10 = worst pain imaginable) on a Likert Scale

12 secondary outcomes

Pain Intensity Measure for Oxycodone/Naltrexone (b)
Time frame: Every 6 hours for 48 hours
Pain Relief Measure for Oxycodone/Naltrexone (a and b formulations)
Time frame: Every 6 hours for 48 hours
Number of Subjects with Changes in Physical Examination from Day 1 Pre-dose to End of Study
Time frame: Pre-Dose Day 1 and Day 8
Number of Subjects with Changes in Pulse Oximetry from Pre-Dose to post-dose time points
Time frame: 48 hours (multiple time points) and at each out patient visit (Days 4, 6, 8)
Number of Subjects with Changes in Blood Chemistry Analytes from baseline to end of study
Time frame: Screening, 48 hours post-dose and Day 8
Number of Subjects with Changes in Hematology Analytes from baseline to end of study
Time frame: Screening, 48 hours post-dose and Day 8
Number of Subjects with Changes in Urinalysis from baseline to end of study
Time frame: Screening, 48 hours post-dose and Day 8
Number of Subjects with Changes in Systolic Blood Pressure from baseline through multiple post-dose time points
Time frame: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of Subjects with Changes in Diastolic Blood Pressure from Baseline through multiple time points post-dose
Time frame: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of Subjects with Changes in Pulse Rate
Time frame: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of Subjects with Changes in Respiratory Rate
Time frame: Pre-Dose Day 1 through Day 3, Day 4, 6, 8
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 1 through 7 days post last dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.

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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.

5 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 Oxycodone Naltrexone (a) and Oxycodone Naltrexone (b) in people with Pain, run by Elite Laboratories, Inc at 5 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 11 inclusion and 35 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 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pain Intensity Measure for Oxycodone/Naltrexone (a) (time frame: Every 6 hours for 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 NCT02401750.

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 9 Aug 2016.