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Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
International
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 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 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 the past 2 years, with the exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

Sites / Locations

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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
November 6, 2014
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT01427270
Brief Title
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe 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 Uncontrolled 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
November 2014
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 (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC 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 chronic low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
455 (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 the past 2 years, with the 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
35242
Country
United States
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Investigational Site
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Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
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United States
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Investigational Site
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Homewood
State/Province
Alabama
ZIP/Postal Code
35209
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United States
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Investigational Site
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Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
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United States
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Investigational Site
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Mobile
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Alabama
ZIP/Postal Code
36608
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United States
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Investigational Site
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Goodyear
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Arizona
ZIP/Postal Code
85395-2511
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United States
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Investigational Site
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Goodyear
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Arizona
ZIP/Postal Code
85395
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United States
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Phoenix
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Arizona
ZIP/Postal Code
85018
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United States
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Phoenix
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Arizona
ZIP/Postal Code
85027
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United States
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Tempe
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Arizona
ZIP/Postal Code
85282
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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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Hot Springs
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Arkansas
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71901
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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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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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Anaheim
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California
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92805
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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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Fresno
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California
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93720
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United States
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Fresno
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California
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93726
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Glendale
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California
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91206
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United States
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La Mesa
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California
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91942
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United States
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Laguna Hills
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California
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92637
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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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Los Angeles
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California
ZIP/Postal Code
90017
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United States
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Los Angeles
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California
ZIP/Postal Code
90025
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United States
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Los Angeles
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California
ZIP/Postal Code
90036
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United States
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Los Gatos
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California
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95032
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United States
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National City
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California
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91950
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United States
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North Hollywood
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California
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91606
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United States
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Oceanside
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California
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92056
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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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Richmond
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California
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94806
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Roseville
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California
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95661
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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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United States
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Sacramento
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California
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95842
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United States
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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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Santa Ana
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California
ZIP/Postal Code
92701
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United States
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Santa Clarita
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California
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91350
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United States
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Valley Village
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California
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91607
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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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New Haven
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Connecticut
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06511
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United States
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Waterbury
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Connecticut
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06708
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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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Boynton Beach
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Florida
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33472
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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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Clearwater
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Florida
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33765
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Clermont
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Florida
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34711
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Coral Gables
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Florida
ZIP/Postal Code
33134
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United States
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Daytona Beach
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Florida
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32117
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United States
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Ft. Lauderdale
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Florida
ZIP/Postal Code
33316
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United States
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Hialeah
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Florida
ZIP/Postal Code
33012
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United States
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Hialeah
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Florida
ZIP/Postal Code
33013
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United States
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Inverness
State/Province
Florida
ZIP/Postal Code
34452
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United States
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Investigational Site
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
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United States
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
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United States
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Investigational Site
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Jupiter
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Florida
ZIP/Postal Code
33458
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United States
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Investigational Site
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Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
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Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34110
Country
United States
Facility Name
Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34113
Country
United States
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Investigational Site
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New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
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United States
Facility Name
Investigational Site
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North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
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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Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
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United States
Facility Name
Investigational Site
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Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
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United States
Facility Name
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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Port Orange
State/Province
Florida
ZIP/Postal Code
32129
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United States
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Investigational Site
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Sanford
State/Province
Florida
ZIP/Postal Code
32771
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United States
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Investigational Site
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South Miami
State/Province
Florida
ZIP/Postal Code
33143
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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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Tampa
State/Province
Florida
ZIP/Postal Code
33613
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United States
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Investigational Site
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Wellington
State/Province
Florida
ZIP/Postal Code
33414
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United States
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Investigational Site
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Austell
State/Province
Georgia
ZIP/Postal Code
30106
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United States
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Investigational Site
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Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
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United States
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Investigational Site
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Canton
State/Province
Georgia
ZIP/Postal Code
30114
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United States
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Investigational Site
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Columbus
State/Province
Georgia
ZIP/Postal Code
31904
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United States
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Investigational Site
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Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
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United States
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Investigational Site
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Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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United States
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Investigational Site
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Perry
State/Province
Georgia
ZIP/Postal Code
31069
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United States
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Investigational Site
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Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
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Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Investigational Site
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Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Investigational Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
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
State/Province
Indiana
ZIP/Postal Code
47714
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United States
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Investigational Site
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Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
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Investigational Site
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Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Investigational Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70435
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United States
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Investigational Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
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United States
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Investigational Site
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Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
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United States
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Investigational Site
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Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
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United States
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Investigational Site
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Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
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United States
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Investigational Site
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North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
Facility Name
Investigational Site
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Investigational Site
City
Pinconning
State/Province
Michigan
ZIP/Postal Code
48650
Country
United States
Facility Name
Investigational Site
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Investigational Site
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Investigational Site
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Investigational Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Investigational Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Investigational Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Investigational Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Investigational Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Investigational Site
City
Elkin
State/Province
North Carolina
ZIP/Postal Code
28621
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
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Investigational Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Investigational Site
City
Groveport
State/Province
Ohio
ZIP/Postal Code
43125
Country
United States
Facility Name
Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
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
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Investigational Site
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Investigational Site
City
Phoenixville
State/Province
Pennsylvania
ZIP/Postal Code
19460
Country
United States
Facility Name
Investigational Site
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
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
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29588
Country
United States
Facility Name
Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Investigational Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Investigational Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Investigational Site
City
Athens
State/Province
Texas
ZIP/Postal Code
75751
Country
United States
Facility Name
Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
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
77005
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
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
Humble
State/Province
Texas
ZIP/Postal Code
77338
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
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Investigational Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Investigational Site
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
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
84107
Country
United States
Facility Name
Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 03
Country
Czech Republic
Facility Name
Investigational Site
City
Most
ZIP/Postal Code
434 64
Country
Czech Republic
Facility Name
Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Investigational Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czech Republic
Facility Name
Investigational Site
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
Investigational Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Investigational Site
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czech Republic
Facility Name
Investigational Site
City
Sternberk
ZIP/Postal Code
785 01
Country
Czech Republic
Facility Name
Investigational Site
City
Vysoke Myto
ZIP/Postal Code
566 23
Country
Czech Republic
Facility Name
Investigational Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Investigational Site
City
Znojmo
ZIP/Postal Code
669 02
Country
Czech Republic
Facility Name
Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Investigational Site
City
Bielsko-Biala
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Investigational Site
City
Gdansk
ZIP/Postal Code
80-286
Country
Poland
Facility Name
Investigational Site
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Investigational Site
City
Gdynia
ZIP/Postal Code
81-366
Country
Poland
Facility Name
Investigational Site
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
Investigational Site
City
Katowice
ZIP/Postal Code
40-683
Country
Poland
Facility Name
Investigational Site
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Investigational Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

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