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

NCT02401750 | Completed Phase 3

• 1 other identifier: ELI-003-2014
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 5

Brief 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 undergone primary, unilateral, distal first metatarsal bunionectomy with osteotomy and internal fixation.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

  Every 6 hours for 48 hours

Secondary Outcomes (12)

• Pain Intensity Measure for Oxycodone/Naltrexone (b)

  Every 6 hours for 48 hours

• Pain Relief Measure for Oxycodone/Naltrexone (a and b formulations)

  Every 6 hours for 48 hours

• Number of Subjects with Changes in Physical Examination from Day 1 Pre-dose to End of Study

  Pre-Dose Day 1 and Day 8

• Number of Subjects with Changes in Pulse Oximetry from Pre-Dose to post-dose time points

  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

  Screening, 48 hours post-dose and Day 8

Study Arms (3)

Oxycodone Naltrexone (a)

EXPERIMENTAL

Double-Blind Oxycodone/Naltrexone, 1 capsule by mouth every 6 hours for 48 hours

Drug: Oxycodone Naltrexone (a)

Oxycodone Naltrexone (b)

EXPERIMENTAL

Double-Blind Oxycodone/Naltrexone , 1 capsule by mouth every 6 hours for 48 hours

Drug: Oxycodone Naltrexone (b)

Placebo

PLACEBO COMPARATOR

Double-Blind Placebo to experimental Oxycodone/Naltrexone, 1 capsule every 6 hours for 48 hours

Drug: Placebo

Interventions

Oxycodone Naltrexone (b) DRUG

Oxycodone Naltrexone (b)

Oxycodone Naltrexone (a) DRUG

Oxycodone Naltrexone (a)

Placebo DRUG

Matches both experimental drugs

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Elite Laboratories, Inc: lead

Study Sites (5)

Premier Research

Phoenix, Arizona, 85027, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Premier Research

Austin, Texas, 78705, United States

Location

Endeavor Clinial Trials

San Antonio, Texas, 78240, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 30, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (5)