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A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mesalamine
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, inflammatory bowel disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis. Female patients need to be postmenopausal or using adequate contraception. Exclusion Criteria: Patients with isolated proctitis Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Asacol 2.4 g/day (400 mg tablet)

Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks

Outcomes

Primary Outcome Measures

Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.

Secondary Outcome Measures

Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.

Full Information

First Posted
July 6, 2006
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00350415
Brief Title
A Double Blind Study for the Treatment of Acute Ulcerative Colitis
Official Title
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).
Detailed Description
This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ulcerative colitis, inflammatory bowel disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Asacol 2.4 g/day (400 mg tablet)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
Primary Outcome Measure Information:
Title
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.
Time Frame
week 3 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis. Female patients need to be postmenopausal or using adequate contraception. Exclusion Criteria: Patients with isolated proctitis Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Krzeski, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
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United States
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Research Facility
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Birmingham
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Alabama
ZIP/Postal Code
35209
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United States
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Research Facility
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Tucson
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Arizona
ZIP/Postal Code
85712
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United States
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Fayetteville
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Arkansas
ZIP/Postal Code
72703
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United States
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Research Facility
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Little Rock
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Arkansas
ZIP/Postal Code
72205
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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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Research Facility
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Burbank
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California
ZIP/Postal Code
91505
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United States
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Research Facility
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Encinitas
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California
ZIP/Postal Code
93024
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United States
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Research Facility
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Los Angeles
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California
ZIP/Postal Code
90067
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United States
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Research Facility
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Los Angeles
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California
ZIP/Postal Code
90274
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United States
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Research Facility
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Mission Hills
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California
ZIP/Postal Code
91345
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United States
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Orange
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California
ZIP/Postal Code
92868
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United States
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Pasadena
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California
ZIP/Postal Code
91105
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United States
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Roseville
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California
ZIP/Postal Code
95661
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United States
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Sacramento
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California
ZIP/Postal Code
95825
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United States
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San Carlos
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California
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94070
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United States
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San Francisco
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California
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94115
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United States
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Lakewood
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Colorado
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80215
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United States
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Littleton
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Colorado
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80120
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United States
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Hamden
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Connecticut
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06518-3691
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United States
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Deland
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Florida
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32720
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United States
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Harbor
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Florida
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34684
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United States
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Hollywood
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Florida
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33021
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United States
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Jacksonville
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Florida
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32256
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United States
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Panama City
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Florida
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33405
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United States
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Zephyrhills
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Florida
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33542
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United States
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Atlanta
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Georgia
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30033
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United States
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Savannah
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Georgia
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31405
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United States
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Arlington Heights
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Illinois
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60005
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United States
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Chicago
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Illinois
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60637
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United States
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Topeka
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Kansas
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60606
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United States
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Louisville
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Kentucky
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40292
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United States
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Baton Rouge
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Louisiana
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70809
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United States
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Shreveport
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Louisiana
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71103
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United States
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Baltimore
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21215
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United States
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Chevy Chase
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Maryland
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20815
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United States
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Reisterstown
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Maryland
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21136
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United States
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Boston
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Massachusetts
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02115
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United States
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Columbia
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Michigan
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65212
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United States
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Minneapolis
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Minnesota
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55455
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United States
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Rochester
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Minnesota
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55905
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United States
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Tupelo
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Mississippi
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38801
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United States
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Kansas City
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Missouri
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64131
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United States
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St. Louis
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Missouri
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63128
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United States
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Omaha
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68131
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Scottsbluff
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Nebraska
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69361
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Egg Harbor Township
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08234
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United States
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Binghamton
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New York
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13903
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United States
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Garden City
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New York
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11530
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United States
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Great Neck
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New York
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11021
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Huntington
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New York
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11743
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United States
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New York
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New York
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10021
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United States
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Rochester
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New York
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14642
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United States
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Troy
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New York
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12180
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United States
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Charlotte
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North Carolina
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28262
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United States
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Wilmington
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North Carolina
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28401
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United States
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Bismarck
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North Dakota
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58501-1640
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United States
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Fargo
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North Dakota
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58104
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United States
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Akron
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Ohio
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44302
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United States
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Cincinnati
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Ohio
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45242
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United States
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Dayton
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Ohio
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45440
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United States
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Warren
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Ohio
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44484
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United States
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Portland
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Oregon
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97220
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United States
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Beaver Falls
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Pennsylvania
ZIP/Postal Code
15010
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United States
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Philadelphia
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Pennsylvania
ZIP/Postal Code
19107
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United States
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York
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Pennsylvania
ZIP/Postal Code
17403
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United States
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Columbia
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South Carolina
ZIP/Postal Code
29203
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United States
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Kingsport
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Tennessee
ZIP/Postal Code
37660
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United States
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Memphis
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Tennessee
ZIP/Postal Code
38120
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United States
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Nashville
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Tennessee
ZIP/Postal Code
37232
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United States
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Austin
State/Province
Texas
ZIP/Postal Code
78743
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United States
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Research Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
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Research Facility
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
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United States
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Research Facility
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
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United States
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Burlington
State/Province
Vermont
ZIP/Postal Code
05401
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United States
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Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
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United States
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Redmond
State/Province
Washington
ZIP/Postal Code
98052
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United States
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Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
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United States
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City
Gornel
State/Province
Gormel
Country
Belarus
Facility Name
Research Facility
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
Research Facility
City
Minsk
ZIP/Postal Code
220013
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Belarus
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Research Facility
City
Vitebsk
ZIP/Postal Code
210037
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Belarus
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City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
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Canada
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Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
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Canada
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Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 112
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Canada
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Guelph
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Ontario
ZIP/Postal Code
N1H 3R3
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Canada
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Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
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Canada
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London
State/Province
Ontario
ZIP/Postal Code
N6A 5K8
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Canada
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Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
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Canada
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Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
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Canada
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City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
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Canada
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City
Longheuil
State/Province
Quebec
ZIP/Postal Code
J4N 1E1
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Canada
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City
Montreal
State/Province
Quebec
ZIP/Postal Code
H31 1E2
Country
Canada
Facility Name
Research Facility
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
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City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Research Facility
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1N4
Country
Canada
Facility Name
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City
Quebec
ZIP/Postal Code
G1L 3L5
Country
Canada
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City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Research Facility
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Research Facility
City
Kralove
ZIP/Postal Code
500 12
Country
Czech Republic
Facility Name
Research Facility
City
Pavlov
Country
Czech Republic
Facility Name
Research Facility
City
Praha 2
ZIP/Postal Code
120 00
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Czech Republic
Facility Name
Research Facility
City
Strakonice
ZIP/Postal Code
3886 29
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Czech Republic
Facility Name
Research Facility
City
Usti nad Labem
ZIP/Postal Code
401 13
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Czech Republic
Facility Name
Research Facility
City
Tallinn
ZIP/Postal Code
10138
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Estonia
Facility Name
Research Facility
City
Tartu
ZIP/Postal Code
51014
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Estonia
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Research Facility
City
Argenti Dome ter
ZIP/Postal Code
1-3
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Hungary
Facility Name
Research Facility
City
Budapest
Country
Hungary
Facility Name
Research Facility
City
Nagyerdei krt
ZIP/Postal Code
98
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Hungary
Facility Name
Research Facility
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Research Facility
City
Santariskiu
State/Province
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Research Facility
City
Kaunas
ZIP/Postal Code
LT-50009
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Lithuania
Facility Name
Research FacilityPanevezys
City
Panevezys
ZIP/Postal Code
LT-35144
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Lithuania
Facility Name
Research Facility
City
Bydgoszcz
ZIP/Postal Code
85-681
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Poland
Facility Name
Research Facility
City
Czestochowa
ZIP/Postal Code
42-200
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Poland
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Research Facility
City
Krakow
ZIP/Postal Code
31-501
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Poland
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Research Facility
City
Lodz
ZIP/Postal Code
90-153
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Poland
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Research Facility
City
Pruszkow
ZIP/Postal Code
05-800
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Poland
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Research Facility
City
Sopot
ZIP/Postal Code
81-756
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Poland
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Research Facility
City
Warszawa
ZIP/Postal Code
02-57
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Poland
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Research Facility
City
Wtoctawek
ZIP/Postal Code
87-800
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Poland
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Research Facility
City
San Juan
ZIP/Postal Code
5067
Country
Puerto Rico
Facility Name
Research Facility
City
Bucuresti 1
State/Province
Bucuresti
ZIP/Postal Code
010825
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Romania
Facility Name
Research Facility
City
Cluj-napoca
ZIP/Postal Code
400162
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Romania
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Research Facility
City
Iasi
ZIP/Postal Code
700111
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Romania
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Research Facility
City
Moscow
State/Province
Mowcow
ZIP/Postal Code
129110
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Russian Federation
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Research Facility
City
Nizhny Novgorod
ZIP/Postal Code
603126
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Russian Federation
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Research Facility
City
St. Petersburg
ZIP/Postal Code
196247
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Russian Federation
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Research Facility
City
Beograd
ZIP/Postal Code
11080
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Serbia
Facility Name
Research Facility
City
Novi Sad
ZIP/Postal Code
21000
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Serbia
Facility Name
Research Facility
City
Zabolotnogo
State/Province
Odesa
ZIP/Postal Code
65025
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Ukraine
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Research Facility
City
Kharkiv
ZIP/Postal Code
61037
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Ukraine
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Research Facility
City
Kyiv
ZIP/Postal Code
04053
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Ukraine
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Research Facility
City
Simpheropol
ZIP/Postal Code
95000
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Ukraine
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Research Facility
City
Zaporizhzhya
ZIP/Postal Code
69050
Country
Ukraine

12. IPD Sharing Statement

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A Double Blind Study for the Treatment of Acute Ulcerative Colitis

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