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A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) 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
Oxycodone HCl 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, Constipation, Moderate to severe

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 low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
  • Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

  • Subjects with rheumatoid arthritis or other inflammatory arthritis;
  • Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
  • Subjects with chronic constipation not related to opioid use;
  • 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 malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

OXN

OXY

Placebo

Arm Description

Oxycodone/Naloxone controlled-release tablets (OXN)

Oxycodone HCl controlled-release tablets (OXY)

Placebo tablets to match OXN or OXY

Outcomes

Primary Outcome Measures

Overall complete spontaneous bowel movement (CSBM) responder rates
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY

Secondary Outcome Measures

CSBM Responder at least 50% of the weeks in the double-blind period
Laxative-free Responder at least 50% of the weeks in the double-blind period

Full Information

First Posted
August 30, 2011
Last Updated
February 11, 2015
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT01427283
Brief Title
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Official Title
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation 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, Constipation, Moderate to severe

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
OXN
Arm Type
Experimental
Arm Description
Oxycodone/Naloxone controlled-release tablets (OXN)
Arm Title
OXY
Arm Type
Active Comparator
Arm Description
Oxycodone HCl controlled-release tablets (OXY)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets to match OXN or OXY
Intervention Type
Drug
Intervention Name(s)
Oxycodone/Naloxone controlled-release
Intervention Description
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
Intervention Type
Drug
Intervention Name(s)
Oxycodone HCl controlled-release
Other Intervention Name(s)
OxyContin
Intervention Description
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets to match OXN or OXY taken orally every 12 hours
Primary Outcome Measure Information:
Title
Overall complete spontaneous bowel movement (CSBM) responder rates
Description
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
Time Frame
Weeks 1 through 12
Secondary Outcome Measure Information:
Title
CSBM Responder at least 50% of the weeks in the double-blind period
Time Frame
Weeks 1 through 12
Title
Laxative-free Responder at least 50% of the weeks in the double-blind period
Time Frame
Weeks 1 through 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 low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation; Subjects must have a self-reported history of opioid induced constipation (OIC). Exclusion Criteria include: Subjects with rheumatoid arthritis or other inflammatory arthritis; Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months; Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility; Subjects with chronic constipation not related to opioid use; 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 malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated. Other protocol specific inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
Investigational Site
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
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Investigational Site
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Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
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Investigational Site
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Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
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Investigational Site
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
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United States
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Investigational Site
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Mobile
State/Province
Alabama
ZIP/Postal Code
36608
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United States
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Investigational Site
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Mesa
State/Province
Arizona
ZIP/Postal Code
85202
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United States
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Investigational Site
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Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
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United States
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Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
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United States
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Sun Lakes
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Arizona
ZIP/Postal Code
85248
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United States
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Tucson
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Arizona
ZIP/Postal Code
85704
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United States
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Tucson
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Arizona
ZIP/Postal Code
85712
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United States
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Little Rock
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Arkansas
ZIP/Postal Code
72211
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United States
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Sherwood
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Arkansas
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72120
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United States
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Anaheim
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California
ZIP/Postal Code
92801
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United States
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Anaheim
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California
ZIP/Postal Code
92804
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United States
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Artesia
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California
ZIP/Postal Code
90701
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United States
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Cerritos
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California
ZIP/Postal Code
90703
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United States
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Chino
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California
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91710
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United States
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El Cajon
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California
ZIP/Postal Code
92020
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United States
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Encino
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California
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91436
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United States
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Fountain Valley
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California
ZIP/Postal Code
92708
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United States
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Fresno
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California
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93720
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United States
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Garden Grove
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California
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92843
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United States
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Garden Grove
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California
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92844
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United States
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Laguna Hills
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California
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92653
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United States
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Lakewood
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California
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90712
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United States
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Lincoln
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California
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95648
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United States
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Lomita
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California
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90717
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United States
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Long Beach
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California
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90806
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United States
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Oceanside
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California
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92054
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United States
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Orange
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California
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92868
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United States
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Paramount
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California
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90723
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United States
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Sacramento
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California
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95823
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San Bernardino
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92408
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San Diego
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California
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92103
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San Diego
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California
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92114
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United States
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Thousand Oaks
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California
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91360
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United States
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Torrance
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California
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90509
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United States
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Colorado Springs
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Colorado
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80907
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United States
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Colorado Springs
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Colorado
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80909
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Denver
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Colorado
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80246
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United States
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Golden
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Colorado
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80401
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United States
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Aventura
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Florida
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33180
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United States
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Bradenton
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Florida
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34209
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United States
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Chiefland
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Florida
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32626
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Clermont
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Florida
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34711
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Daytona Beach
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Florida
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32117
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Deland
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32720
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Edgewater
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Florida
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32132
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Ft. Lauderdale
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Florida
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33316
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Ft. Myers
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Florida
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33916
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Hialeah
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Florida
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33010
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United States
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Hialeah
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Florida
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33012
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United States
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Inverness
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Florida
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34452
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United States
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Jacksonville
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Florida
ZIP/Postal Code
32216
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United States
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Jacksonville
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Florida
ZIP/Postal Code
32256
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United States
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Jacksonville
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Florida
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32257
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United States
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Miami Beach
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Florida
ZIP/Postal Code
33140
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United States
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Miami
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Florida
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33015
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United States
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Miami
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Florida
ZIP/Postal Code
33125
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United States
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Miami
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Florida
ZIP/Postal Code
33126
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United States
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City
Miami
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Florida
ZIP/Postal Code
33135
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United States
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City
Miami
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Florida
ZIP/Postal Code
33136
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United States
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City
Miami
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Florida
ZIP/Postal Code
33144
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United States
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Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
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United States
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Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
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United States
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Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
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United States
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Investigational Site
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Miami
State/Province
Florida
ZIP/Postal Code
33185
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United States
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Investigational Site
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Naples
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Florida
ZIP/Postal Code
34110
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United States
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Naples
State/Province
Florida
ZIP/Postal Code
34113
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United States
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Investigational Site
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New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
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United States
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Investigational Site
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North Miami
State/Province
Florida
ZIP/Postal Code
33161
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United States
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Investigational Site
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Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
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United States
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Investigational Site
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Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
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Investigational Site
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Oviedo
State/Province
Florida
ZIP/Postal Code
32765
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United States
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Investigational Site
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Plantation
State/Province
Florida
ZIP/Postal Code
33317
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United States
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Investigational Site
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Tamarac
State/Province
Florida
ZIP/Postal Code
33321
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United States
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Investigational Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33607
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United States
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Investigational Site
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West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
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United States
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Investigational Site
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Atlanta
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Georgia
ZIP/Postal Code
30308
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United States
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Investigational Site
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Austell
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Georgia
ZIP/Postal Code
30106
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United States
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Snellville
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Georgia
ZIP/Postal Code
30078
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United States
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Boise
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Idaho
ZIP/Postal Code
83704
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United States
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Boise
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Idaho
ZIP/Postal Code
83713
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United States
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Chicago
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Illinois
ZIP/Postal Code
60616
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United States
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Chicago
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Illinois
ZIP/Postal Code
60622
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United States
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Investigational Site
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Chicago
State/Province
Illinois
ZIP/Postal Code
60657
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United States
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Investigational Site
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Evansville
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Indiana
ZIP/Postal Code
47714
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United States
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Investigational Site
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Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
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United States
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Investigational Site
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Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
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United States
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Investigational Site
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Wichita
State/Province
Kansas
ZIP/Postal Code
67203
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United States
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Investigational Site
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Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
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United States
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Investigational Site
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Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
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United States
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Investigational Site
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Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
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United States
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Investigational Site
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New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
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United States
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Investigational Site
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Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
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United States
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Investigational Site
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Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
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United States
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Investigational Site
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Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
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United States
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Investigational Site
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Florissant
State/Province
Missouri
ZIP/Postal Code
63031
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United States
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Investigational Site
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Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
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United States
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Investigational Site
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Atco
State/Province
New Jersey
ZIP/Postal Code
08004
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United States
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Investigational Site
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Great Neck
State/Province
New York
ZIP/Postal Code
11023
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United States
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Investigational Site
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Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
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United States
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New York
State/Province
New York
ZIP/Postal Code
10023
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United States
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Investigational Site
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Rochester
State/Province
New York
ZIP/Postal Code
14618
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United States
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Investigational Site
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Williamsville
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New York
ZIP/Postal Code
14221
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United States
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Durham
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North Carolina
ZIP/Postal Code
27710
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United States
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Elkin
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North Carolina
ZIP/Postal Code
28621
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United States
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Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Investigational Site
City
Moraine
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73119
Country
United States
Facility Name
Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Investigational Site
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Investigational Site
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
Investigational Site
City
Red Lion
State/Province
Pennsylvania
ZIP/Postal Code
17356
Country
United States
Facility Name
Investigational Site
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29588
Country
United States
Facility Name
Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Investigational Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Investigational Site
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
Facility Name
Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Investigational Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Investigational Site
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Investigational Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Investigational Site
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Investigational Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Investigational Site
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Investigational Site
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

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