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Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxycodone/Naloxone Controlled-release
Placebo
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Chronic pain, Opioid, Moderate to severe chronic low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria include:

  • Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
  • The back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation (above the knee);
  • Subjects must be on opioid analgesic therapy for low back pain which:
  • Has been ongoing for at least 4 weeks prior to the screening visit and,
  • Consists of a stable opioid regimen at a total average daily dose equivalent to 20 to 160 mg (inclusive) of morphine for the last 2 weeks prior to the screening visit. Subjects taking tramadol ≥ 100 mg daily on a stable regimen for the last 2 weeks prior to the screening visit will also meet this criterion;
  • Subjects must require continuation of opioid analgesic treatment in the range of 40 to 160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study;
  • Subjects must have an average pain over the last 14 days score ≥ 5 (on an 11-point numerical rating scale [NRS]) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication;
  • Subjects must have an average pain over the last 24 hours score ≥ 5 (on an 11-point NRS) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication;
  • Subjects must be willing and able to be compliant with the protocol, capable of subjective evaluation, able to read and understand questionnaires, willing and able to use a diary per protocol, and read, understand, and sign the written informed consent in English.

Exclusion Criteria include:

  • Female subjects who are pregnant (positive serum beta human chorionic gonadotropin [β hCG] test) or lactating;
  • Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids. This does not include subjects who have experienced common opioid side effects (e.g., nausea, constipation);
  • Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgia;
  • Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uric-acid-lowering therapy without any attacks for ≥ 2 years and the subject has not been using nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors on a regular basis;
  • Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic pain conditions;
  • Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
  • Subjects with a history of opioid, alcohol, medication, or illicit drug abuse or addiction;
  • Subjects who have received any investigational medication within 30 days of first dose of study drug;
  • Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit;
  • Subjects who have received study drug in a clinical study of oxycodone/naloxone controlled-release (OXN or ONU).

Other protocol specific inclusion/exclusion criteria may apply.

Sites / Locations

  • Alabama Orthopaedic Center, PC
  • Alliance Clinical Research
  • Winston Technology Research, LLC
  • Monte Sano Clinical Research, LLC
  • Research Facility
  • Radiant Research, Inc.
  • Dedicated Clinical Research
  • Arizona Research Center
  • Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC
  • Quality of Life Medical & Research Center, LLC
  • Ortho Surgeons
  • Orange County Research Institute
  • Physician Alliance Research Center
  • Advanced Pain Research Institute
  • Southbay Pharma Research
  • Providence Clinical Research
  • Med Center
  • Advanced Pain Management and Rehabilitation Medical Group, Inc.
  • Catalina Research Institute, LLC
  • Synergy Clinical Research of Escondido
  • Valley Research
  • RX Clinical Research, Inc.
  • TriWest Research Associates
  • Pacific Coast Pain Management Center
  • South Orange County Surgical Medical Group
  • Clinical Trials Research
  • L.A. Pain and Wellness Institute
  • Newport Beach Clinical Research Associates, Inc.
  • Lotus Clinical Research
  • Northern California Clinical Research Center
  • Probe Clinical Research Corporation
  • Northern California Research
  • Probe Clinical Research Corporation
  • Denver Internal Medicine Group
  • Front Range Clinical Research
  • New England Research Associates, LLC
  • Orthopedic Research Institute
  • Coastal Orthopedics & Pain Management
  • Southeast Clinical Research, LLC
  • Innovative Research of West Florida, Inc.
  • Clinical Research of West Florida, Inc.
  • Omega Research Consultants, LLC
  • S & W Clinical Research
  • Southeastern Integrated Medical, PL
  • Health Care Family Rehab & Research Center
  • Eastern Research, Inc.
  • Southeast Clinical Research, LLC
  • Florida Institute of Medical Research
  • Drug Study Institute
  • Pharma Care Research, Inc.
  • Advanced Pharma CR, LLC
  • Compass Research, LLC
  • Peninsula Research, Inc.
  • Sarasota Clinical Research, LLC
  • Sarasota Pain Medicine Research
  • Vita Research Solutions & Medical Center, Inc.
  • Stedman Clinical Trials
  • Advanced Research Institute, Inc.
  • Palm Beach Research Center
  • National Pain Research Institute, LLC
  • Independent Neurodiagnostic Clinic
  • In-Quest Medical Research, LLC
  • Georgia Institute for Clinical Research, LLC
  • Research Facility
  • Better Health Clinical Research, Inc.
  • SouthCoast Medical Group
  • Georgia Clinical Research, LLC
  • The Pain Center
  • Clinical Investigation Specialists, Inc.
  • Destiny Clinical Research, LLC
  • MediSphere Medical Research Center, LLC
  • Northwest Indiana Center for Clinical Research
  • International Clinical Research Institute, Inc.
  • Clinical Trials Technology, Inc. CTT Consultants, Inc.
  • The Pain Treatment Center of the Bluegrass
  • Louisiana Research Associates, Inc.
  • Research Facility
  • Mid-Atlantic Medical Research Centers
  • MidAtlantic Pain Medicine Center
  • Beacon Clinical Research, LLC
  • ActivMed Practices and Research
  • Medvadis Research Corporation
  • Great Lakes Research Group, Inc.
  • Great Lakes Family Care
  • Great Lakes Research Group, Inc.
  • Medex Healthcare Research, Inc.
  • Mercy Health Research
  • Sundance Clinical Research, LLC
  • Meridian Clinical Research, LLC
  • Research Facility
  • South Jersey Medical Associates, P.A.
  • University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ)
  • Five Towns Neuroscience Research/Five Towns Neurology
  • Long Island Gastrointestinal Research Group, LLP
  • Medex Healthcare Research, Inc.
  • Research Across America
  • Upstate Clinical Research Associates, LLC
  • Gaffney Health Services
  • Box Arthritis & Rheumatology of the Carolinas, PLLC
  • PharmQuest
  • Peters Medical Research
  • Plains Medical Clinic, LLC
  • Clinical Inquest Center Ltd.
  • Community Research
  • Columbus Clinical Research, Inc.
  • Hometown Urgent Care and Research
  • Prestige Clinical Research
  • Hometown Urgent Care and Research
  • J L Clinical Research
  • Bone Joint and Spine Surgeons, Inc.
  • Pharmacotherapy Research Associates, Inc.
  • Neuropsychiatric Center and NPC Research
  • Health Research Institute
  • Paradigm Research Professionals, LLC
  • Bend Memorial Clinic
  • Pain Consultants of Oregon
  • Willamette Valley Clinical Studies
  • Sunstone Medical Research, LLC
  • Allegheny Pain Management, PC
  • Paramount Clinical Research
  • Altoona Center for Clinical Research
  • The Clinical Trial Center, LLC
  • Central Pennsylvania Clinical Research
  • CRI Worldwide, LLC
  • Dairyland Medical Center
  • New England Center for Clinical Research, Inc
  • Hartwell Research Group, LLC
  • Greenville Pharmaceutical Research, Inc.
  • Internal Medicine of Greer
  • Meridian Clinical Research
  • Health Concepts Wellness Center
  • Integrity Clinical Research, LLC
  • FutureSearch Trials of Neurology
  • Austin Center for Clinical Research
  • Corpus Christi Pain Medicine
  • FutureSearch Trials of Dallas
  • Pineloch Medical Clinic
  • Clinical Trial Network
  • Southwest Clinical Trials
  • Protenium Clinical Research, LLC
  • TEAM Research of Central Texas
  • West Texas Medical Associates
  • Sun Research Institute
  • Research Facility
  • Summit Pain Management
  • Alpine Medical Group
  • Highland Clinical Research
  • Virginia Research Center
  • Hilltop Medical Center
  • Independence Family Medicine
  • Universal Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OXN

Placebo

Arm Description

Oxycodone/Naloxone Controlled-release Tablets (OXN)

Placebo tablets to match OXN

Outcomes

Primary Outcome Measures

The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period
The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.

Secondary Outcome Measures

The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.
Patient Global Impression of Change (PGIC)
The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "much improved" and "very much improved" was summarized by treatment group and compared between groups using an exact test.

Full Information

First Posted
May 20, 2011
Last Updated
October 14, 2015
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT01358526
Brief Title
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Pain Due to Chronic Low Back Pain Who Require Around-the-clock Opioid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma LP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Chronic pain, Opioid, Moderate to severe chronic low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1095 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OXN
Arm Type
Experimental
Arm Description
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets to match OXN
Intervention Type
Drug
Intervention Name(s)
Oxycodone/Naloxone Controlled-release
Other Intervention Name(s)
TARGINIQ ER
Intervention Description
Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets to match OXN taken orally every 12 hours
Primary Outcome Measure Information:
Title
The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period
Description
The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.
Time Frame
24 hours (Week 12)
Secondary Outcome Measure Information:
Title
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
Description
The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.
Time Frame
Weeks 4, 8, and 12
Title
Patient Global Impression of Change (PGIC)
Description
The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "much improved" and "very much improved" was summarized by treatment group and compared between groups using an exact test.
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
Description
A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.
Time Frame
Week 12
Title
Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
Description
A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria include: Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period; The back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation (above the knee); Subjects must be on opioid analgesic therapy for low back pain which: Has been ongoing for at least 4 weeks prior to the screening visit and, Consists of a stable opioid regimen at a total average daily dose equivalent to 20 to 160 mg (inclusive) of morphine for the last 2 weeks prior to the screening visit. Subjects taking tramadol ≥ 100 mg daily on a stable regimen for the last 2 weeks prior to the screening visit will also meet this criterion; Subjects must require continuation of opioid analgesic treatment in the range of 40 to 160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study; Subjects must have an average pain over the last 14 days score ≥ 5 (on an 11-point numerical rating scale [NRS]) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication; Subjects must have an average pain over the last 24 hours score ≥ 5 (on an 11-point NRS) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication; Subjects must be willing and able to be compliant with the protocol, capable of subjective evaluation, able to read and understand questionnaires, willing and able to use a diary per protocol, and read, understand, and sign the written informed consent in English. Exclusion Criteria include: Female subjects who are pregnant (positive serum beta human chorionic gonadotropin [β hCG] test) or lactating; Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids. This does not include subjects who have experienced common opioid side effects (e.g., nausea, constipation); Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgia; Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uric-acid-lowering therapy without any attacks for ≥ 2 years and the subject has not been using nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors on a regular basis; Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic pain conditions; Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study; Subjects with a history of opioid, alcohol, medication, or illicit drug abuse or addiction; Subjects who have received any investigational medication within 30 days of first dose of study drug; Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit; Subjects who have received study drug in a clinical study of oxycodone/naloxone controlled-release (OXN or ONU). Other protocol specific inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
Alabama Orthopaedic Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alliance Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Winston Technology Research, LLC
City
Haleyville
State/Province
Alabama
ZIP/Postal Code
35565
Country
United States
Facility Name
Monte Sano Clinical Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Facility
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Dedicated Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Quality of Life Medical & Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Ortho Surgeons
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Orange County Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Physician Alliance Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Advanced Pain Research Institute
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Southbay Pharma Research
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Med Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Advanced Pain Management and Rehabilitation Medical Group, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Synergy Clinical Research of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
RX Clinical Research, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
TriWest Research Associates
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pacific Coast Pain Management Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
South Orange County Surgical Medical Group
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
L.A. Pain and Wellness Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Northern California Clinical Research Center
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Probe Clinical Research Corporation
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Probe Clinical Research Corporation
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Denver Internal Medicine Group
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Front Range Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
New England Research Associates, LLC
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Orthopedic Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Coastal Orthopedics & Pain Management
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Southeast Clinical Research, LLC
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Omega Research Consultants, LLC
City
Debary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
S & W Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Southeastern Integrated Medical, PL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Health Care Family Rehab & Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Eastern Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Southeast Clinical Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Pharma Care Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Peninsula Research, Inc.
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Sarasota Clinical Research, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Sarasota Pain Medicine Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34238
Country
United States
Facility Name
Vita Research Solutions & Medical Center, Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
National Pain Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Independent Neurodiagnostic Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
In-Quest Medical Research, LLC
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Georgia Institute for Clinical Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Research Facility
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Better Health Clinical Research, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
SouthCoast Medical Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Georgia Clinical Research, LLC
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
The Pain Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Destiny Clinical Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Northwest Indiana Center for Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
International Clinical Research Institute, Inc.
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Clinical Trials Technology, Inc. CTT Consultants, Inc.
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
The Pain Treatment Center of the Bluegrass
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Louisiana Research Associates, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Research Facility
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Mid-Atlantic Medical Research Centers
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
MidAtlantic Pain Medicine Center
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
ActivMed Practices and Research
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Medvadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472-3930
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Great Lakes Family Care
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Pinconning
State/Province
Michigan
ZIP/Postal Code
48650
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Facility
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
South Jersey Medical Associates, P.A.
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ)
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Five Towns Neuroscience Research/Five Towns Neurology
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Long Island Gastrointestinal Research Group, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Research Across America
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Upstate Clinical Research Associates, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Gaffney Health Services
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28205
Country
United States
Facility Name
Box Arthritis & Rheumatology of the Carolinas, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Plains Medical Clinic, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Clinical Inquest Center Ltd.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Columbus Clinical Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
J L Clinical Research
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Bone Joint and Spine Surgeons, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Pharmacotherapy Research Associates, Inc.
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Neuropsychiatric Center and NPC Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109-3834
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Paradigm Research Professionals, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Pain Consultants of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allegheny Pain Management, PC
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Paramount Clinical Research
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Central Pennsylvania Clinical Research
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Dairyland Medical Center
City
Red Lion
State/Province
Pennsylvania
ZIP/Postal Code
17356
Country
United States
Facility Name
New England Center for Clinical Research, Inc
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Hartwell Research Group, LLC
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Greenville Pharmaceutical Research, Inc.
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Internal Medicine of Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Meridian Clinical Research
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Health Concepts Wellness Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Huntingdon
State/Province
Tennessee
ZIP/Postal Code
38344
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Austin Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Corpus Christi Pain Medicine
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78415
Country
United States
Facility Name
FutureSearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pineloch Medical Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Protenium Clinical Research, LLC
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
TEAM Research of Central Texas
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
West Texas Medical Associates
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Research Facility
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Summit Pain Management
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Alpine Medical Group
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Virginia Research Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Hilltop Medical Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Independence Family Medicine
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Universal Research Group
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf
Description
TARGINIQ ER Labeling

Learn more about this trial

Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

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