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Trial record 1 of 1 for:    NCT03464097
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A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03464097
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Ozanimod Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 3, MULTI CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS MAINTENANCE THERAPY FOR MODERATELY TO SEVERLY ACTIVE CROHN's DISEASE
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Administration of oral Ozanimod
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 40 weeks
Drug: Ozanimod
Ozanimod

Placebo Comparator: Administration of Placebo
Subjects will receive placebo capsule orally once daily x 40 weeks
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of subjects with a CDAI score of < 150 at Week 40 [ Time Frame: Up to approximately week 40 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  2. Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% at Week 40 [ Time Frame: Up to approximately week 40 ]
    The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.


Secondary Outcome Measures :
  1. Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points, with abdominal pain and a stool frequency no worse than baseline at Week 40 [ Time Frame: Up to approximately week 40 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.

  2. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 at Week 40 [ Time Frame: Up to approximately week 40 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  3. Proportion of subjects with a CDAI score of < 150 at both pre-randomization and Week 40 [ Time Frame: Up to approximately week 40 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD

  4. Proportion of subjects with a CDAI score of < 150 at Week 40 in subjects in with a CDAI score < 150 at pre-randomization [ Time Frame: Up to approximately week 40 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  5. Proportion of subjects with a CDAI score < 150 in subjects off corticosteroids at Week 40 [ Time Frame: Up to approximately week 40 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  6. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥10% at Week 40 [ Time Frame: Up to approximately week 40 ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

  7. Proportion of subjects with histological improvement (ie. as measured by Global Histologic Disease Activity score changes (Geboes, 2000) at Week 40 [ Time Frame: Up to approximately week 40 ]
    Global Histologic Disease Activity score is a measure of histologic inflammation.

  8. Proportion of subjects with CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% at Week 40 [ Time Frame: Up to approximately week 40 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD. The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.

  9. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points at Week 40 [ Time Frame: Up to approximately week 40 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  10. Mucosal healing at Week 40 [ Time Frame: Up to approximately week 40 ]
    Mucosal healing is measured by histologic inflammation

  11. Time to relapse [ Time Frame: Up to approximately week 40 ]
    Relapse will be assessed by endoscopy and clinical symptoms

  12. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% at Week 40 [ Time Frame: Up to approximately week 40 ]
    CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. CDEIS score considers 4 parameters (deep ulcerations, superficial ulcerations, surface involved by disease, and surface involved by ulcerations), each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. The presence of stenosis, as a result of ulcer or not, increases the score at the end of the computation.

  13. Improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) scores [ Time Frame: Up to approximately week 40 ]
    The IBDQ is a frequently used outcome parameter in clinical trials. The IBDQ is a responsive instrument for reflection quick change in the quality of life of patients with CD, within a 2-week period. The IBDQ has evolved into a standard for measuring disease-specific quality of life in patients with CD.

  14. Improvement in 36-Item Short Form-36 Survey (SF-36) scores [ Time Frame: Up to approximately week 40 ]
    The medical outcomes SF-36 questionnaire provides a measure of the subject's health status.

  15. Improvement in Work Productivity and Activity Impairment questionnaire for Crohn's disease (WPAI)-CD scores [ Time Frame: Up to approximately week 40 ]
    The WPAI-CD is a validated, reliable and responsive instrument that assesses the impact of CD on work and activity.

  16. Improvement in EuroQol five dimensions questionnaire (EQ-5D) scores [ Time Frame: Up to approximately week 40 ]
    The EQ-5D is a validated, 6-item, self-administered instrument designed to measure generic health status.

  17. Differences in CD-related hospitalizations, procedures, and surgery [ Time Frame: Up to approximately week 40 ]
    The number of Crohn's disease related hospitalizations, surgeries, and procedures will be collected by counting healthcare resource utilization encounters, and comparing them and assessing the cost differences between ozanimod and placebo



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject fulfilled the inclusion criteria at time of entry into the Induction Study (RPC01-3201 or RPC01-3202) and have completed the Week 12 efficacy assessments of the Induction Study.
  2. Subject is in clinical response (a reduction from baseline in Crohn's Disease Activity Index (CDAI) of ≥ 100 points or CDAI score of < 150 points) or in clinical remission based on an average stool frequency score ≤ 3 with a stool frequency no worse than baseline and an average abdominal pain score ≤ 1 or CDAI score of < 150 points at Week 12 of the Induction Study.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Exclusions Related to General Health:

  1. Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
  2. Subject is pregnant, lactating, or has a positive urine beta human chorionic gonadotropin (β-hCG) measured prior to randomization.
  3. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
  4. Subject has a history of uveitis (within the last year) or clinically confirmed diagnosis of macular edema.
  5. Subject has undergone a colectomy (partial or total), small bowel resection, or an ostomy (ie, temporary colostomy, permanent colostomy, ileostomy, or other enterostomy) since Day 1 of the Induction Studies or has developed symptomatic fistula (enterocutaneous or entero-enteral).
  6. Subject has had active cancer within 5 years including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that have been excised and resolved) or colonic dysplasia that has not been completely removed.

    Exclusions Related to Medications:

  7. Subject has received any of the following therapies during the Induction Study:

    1. rectal steroid therapy (ie, steroids administered to the rectum or sigmoid via foam or enema)
    2. rectal 5-ASA (ie, 5-ASA steroids administered to the rectum)
    3. parenteral corticosteroids
    4. total parenteral nutrition therapy
    5. antibiotics for the treatment of CD
    6. immunomodulatory agents (6-MP, azathioprine, including but not limited to cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
    7. immunomodulatory biologic agents
    8. investigational agents
    9. apheresis
  8. Subject has current or planned treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate) during the Maintenance Study.
  9. Subject has chronic nonsteroidal anti-inflammatory drug (NSAID) use (note: occasional use of NSAIDs and acetaminophen [eg, headache, arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day is permitted).
  10. Subject has received treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with 2 or more agents in combination known to prolong PR interval.
  11. Subject has received a live vaccine within 4 weeks prior to first dose of IP.
  12. Subject has received previous treatment with lymphocyte-depleting therapies (eg, Campath™, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, or daclizumab).
  13. Subject has received previous treatment with D-penicillamine, leflunomide or thalidomide.
  14. Subject has received previous treatment with natalizumab or fingolimod.
  15. Subject has received previous treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 16 weeks of first dose of IP.
  16. Subject has a history of treatment with IV immune globulin (IVIg), or plasmapheresis, within 3 months prior to first dose of IP.

    Exclusions Related to Laboratory Results:

  17. Subject has ECG results showing any clinically significant abnormality at Week 12 of the Induction Study.
  18. Subject has confirmed aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the ULN
  19. Subject has a forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 50% of predicted values prior to randomization.
  20. Subject has confirmed absolute lymphocyte count (ALC) < 200 cells/μL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464097


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

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United States, Arizona
Holland Center for Family Health Recruiting
Peoria, Arizona, United States, 85381
Elite Clinical Studies, LLC Not yet recruiting
Phoenix, Arizona, United States, 85018
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Arkansas Gastroenterology, P.A. Recruiting
North Little Rock, Arkansas, United States, 72117
United States, California
Sharp Chula Vista Medical Center Recruiting
Chula Vista, California, United States, 91911
Kindred Medical Institute for Clinical Trials, LLC Not yet recruiting
Corona, California, United States, 92879
Valley View Internal Medicine Recruiting
Garden Grove, California, United States, 92843
UCSD Medical Center Not yet recruiting
La Jolla, California, United States, 92037
San Diego Clinical Trials Recruiting
La Mesa, California, United States, 91942
OM Research Recruiting
Lancaster, California, United States, 93534
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Southern California Research Institute Medical Group, Inc. Recruiting
Los Angeles, California, United States, 90045
Matrix Clinical Research Inc Not yet recruiting
Los Angeles, California, United States, 90048
Gastrointestinal Biosciences Recruiting
Los Angeles, California, United States, 90067
VA Northern California Health Care System Not yet recruiting
Mather, California, United States, 95655
Facey Medical Foundation (Parent) Recruiting
Mission Hills, California, United States, 91345
ABS Health, LLC Recruiting
Mission Viejo, California, United States, 92691
Alliance Clinical Research Recruiting
Oceanside, California, United States, 92056
Palo Alto Center-Palo Alto Medical Foundation Research Institute Recruiting
Palo Alto, California, United States, 94304
Stanford Health Care (SHC) - Gastroenterology Clinic Not yet recruiting
Palo Alto, California, United States, 94304
Havana Research Institute LLC Recruiting
Pasadena, California, United States, 91105
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 92377
Sutter Medical Group Recruiting
Roseville, California, United States, 95661
Medical Associates Research Group Recruiting
San Diego, California, United States, 902123
New Hope Research Development Recruiting
West Covina, California, United States, 91790
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Childrens Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Peak Gastroenterology Associates Recruiting
Colorado Springs, Colorado, United States, 80907
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Connecticut Clinical Research Foundation Recruiting
Bristol, Connecticut, United States, 06010
Yale University Recruiting
New Haven, Connecticut, United States, 06510
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Gastro Florida Recruiting
Clearwater, Florida, United States, 33756-3839
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Clearwater, Florida, United States, 33765
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Clermont, Florida, United States, 34711
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Cutler Bay, Florida, United States, 33157
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Doral, Florida, United States, 33166
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Edgewater, Florida, United States, 32132
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza Not yet recruiting
Gainesville, Florida, United States, 32608
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Hialeah, Florida, United States, 33010
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Hialeah, Florida, United States, 33016
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Hialeah, Florida, United States, 33016
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Hollywood, Florida, United States, 33021
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Homestead, Florida, United States, 33033
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Kissimmee, Florida, United States, 34759
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Largo, Florida, United States, 33777
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Lauderdale Lakes, Florida, United States, 33319
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Lighthouse Point, Florida, United States, 33064
Center For Advanced Gastroenterology Recruiting
Maitland, Florida, United States, 32751
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Miami Springs, Florida, United States, 33166
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Miami, Florida, United States, 33125
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Miami, Florida, United States, 33125
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Miami, Florida, United States, 33126
Research Associates of South Florida LLC Recruiting
Miami, Florida, United States, 33156
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Miami, Florida, United States, 33165
Life Medical Center & Research, Inc. Recruiting
Miami, Florida, United States, 33166
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Naples, Florida, United States, 34109
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New Port Richey, Florida, United States, 34655
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New Smyrna Beach, Florida, United States, 32168
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Orlando, Florida, United States, 32810
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Orlando, Florida, United States, 32819
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Palmetto Bay, Florida, United States, 33157
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Pinellas Park, Florida, United States, 33781
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Port Orange, Florida, United States, 32127
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Tampa, Florida, United States, 33612-4799
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Tampa, Florida, United States, 33612
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Tampa, Florida, United States, 33614
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Weeki Wachee, Florida, United States, 34607
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Atlanta, Georgia, United States, 30308
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30342
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Atlanta, Georgia, United States, 30342
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Columbus, Georgia, United States, 31904
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Decatur, Georgia, United States, 30030
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Macon, Georgia, United States, 31201
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Grand Teton Research Group, PLLC Recruiting
Idaho Falls, Idaho, United States, 83404
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Rush University Medical Center - University Cardiovascular Surgeons Not yet recruiting
Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60622
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Chicago, Illinois, United States, 60637
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Oak Lawn, Illinois, United States, 60453-3767
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Urbana, Illinois, United States, 61801
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MediSphere Medical Research Center, LLC Recruiting
Evansville, Indiana, United States, 47714
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Indianapolis, Indiana, United States, 46202
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Iowa Digestive Disease Center Recruiting
Clive, Iowa, United States, 50325
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Cotton ONeil Clinical Research Center Digestive Health Recruiting
Topeka, Kansas, United States, 66606
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University of Kentucky Health Care Recruiting
Lexington, Kentucky, United States, 40536
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Gastroenterology Associates, LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
CroNOLA LLC Recruiting
Houma, Louisiana, United States, 70360
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Lake Charles, Louisiana, United States, 70601
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Marrero, Louisiana, United States, 70072
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Shreveport, Louisiana, United States, 71103
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Catonsville, Maryland, United States, 21228
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Boston, Massachusetts, United States, 02115
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Boston, Massachusetts, United States, 02118
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Chestnut Hill, Massachusetts, United States, 02467
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Worcester, Massachusetts, United States, 01655
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Medex Research Institute Recruiting
Caro, Michigan, United States, 48723
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Kalamazoo, Michigan, United States, 49008
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Novi, Michigan, United States, 48377
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Southfield, Michigan, United States, 48034
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University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
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Rochester, Minnesota, United States, 55905
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Mid America Gastrointestinal Consultants Recruiting
Kansas City, Missouri, United States, 64111
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Saint Louis, Missouri, United States, 63110
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Internal Medicine Specialists Not yet recruiting
Las Vegas, Nevada, United States, 89145
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Lebanon, New Hampshire, United States, 03756
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Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
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Morristown, New Jersey, United States, 07960
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Bronx, New York, United States, 10468
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Brooklyn, New York, United States, 11230
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Brooklyn, New York, United States, 11235
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Fishkill, New York, United States, 12524
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Glens Falls, New York, United States, 12801
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Great Neck, New York, United States, 11021
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Hartsdale, New York, United States, 10530
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New York, New York, United States, 10010
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New York, New York, United States, 10016
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New York, New York, United States, 10021
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New York, New York, United States, 10024
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
DiGiovanna Institute for Medical Education And Research Recruiting
North Massapequa, New York, United States, 11758-1802
Circuit Clinical Recruiting
Orchard Park, New York, United States, 14127
United States, North Carolina
Asheville Gastroenterology Associates, P.A. Recruiting
Asheville, North Carolina, United States, 28801
Carolinas HealthCare System Digestive Health Recruiting
Charlotte, North Carolina, United States, 28204
Internal Medicine Research Recruiting
Charlotte, North Carolina, United States, 28207
PMG Research of Charlotte LLC Recruiting
Charlotte, North Carolina, United States, 28209
Carolina Research Center Recruiting
Greenville, North Carolina, United States, 27834
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Winston-Salem, North Carolina, United States, 27103
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Great Lakes Medical Research, LLC Recruiting
Beachwood, Ohio, United States, 44122
Cleveland Clinic - Taussig Cancer Institute Recruiting
Cleveland, Ohio, United States, 44195
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Advance Clinical Research - Dayton Internal Medicine Recruiting
Dayton, Ohio, United States, 45417
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
Paramount Medical Research & Consulting, LLC Recruiting
Middleburg Heights, Ohio, United States, 44130
Great Lakes Medical Research, LLC Recruiting
Warren, Ohio, United States, 44483
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Cancer Care Associates of OK-N PorterAvenue Recruiting
Norman, Oklahoma, United States, 73071
University of Oklahoma Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Digestive Disease Specialists Inc. Not yet recruiting
Oklahoma City, Oklahoma, United States, 73109
Digestive Disease Specialists Recruiting
Oklahoma City, Oklahoma, United States, 73112
Allergy, Asthma and Immunology Center, PC Recruiting
Tulsa, Oklahoma, United States, 74136
Central States Research, LLC Not yet recruiting
Tulsa, Oklahoma, United States, 74136
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Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
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Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Penn State University Milton S Hershey Medical Center Recruiting
State College, Pennsylvania, United States, 16803
United States, Tennessee
Quality Medical Research Recruiting
Nashville, Tennessee, United States, 37211
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Advanced Gastroenterology Recruiting
Union City, Tennessee, United States, 38261
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Avant Research Associates, LLC - Austin Recruiting
Austin, Texas, United States, 78704
Avant Research Associates, LLC - Beaumont Not yet recruiting
Beaumont, Texas, United States, 77702
San Antonio Military Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
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Houston, Texas, United States, 77030
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Biopharma Informatic Inc. Research Center Recruiting
Houston, Texas, United States, 77043
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Houston, Texas, United States, 77058
GI Specialists of Houston Recruiting
Houston, Texas, United States, 77070
Premier Vein and Vascular Center Recruiting
Houston, Texas, United States, 77084
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Houston, Texas, United States, 77089
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Houston, Texas, United States, 77098
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Pasadena, Texas, United States, 77505
Ygenics Not yet recruiting
Plano, Texas, United States, 75093
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Richardson, Texas, United States, 75082
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants - Southlake Recruiting
Southlake, Texas, United States, 76092
Baylor Scott and White Health Recruiting
Temple, Texas, United States, 76508
Digestive Health Specialists of Tyler Recruiting
Tyler, Texas, United States, 75701
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Gastroenterology Associates, PC Recruiting
Gainesville, Virginia, United States, 20155
Blue Ridge Medical Research Recruiting
Lynchburg, Virginia, United States, 24502
Summit Clinical Research, LLC Recruiting
Petersburg, Virginia, United States, 23805
The Gastroenterology Group Recruiting
Reston, Virginia, United States, 20191
McGuire Veterans Affairs Medical Center Recruiting
Richmond, Virginia, United States, 23249
Carilion Clinic Recruiting
Roanoke, Virginia, United States, 24016
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Suffolk, Virginia, United States, 23434
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University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
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Spokane, Washington, United States, 99204
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Aurora Health Care Aurora Research Recruiting
Grafton, Wisconsin, United States, 53024
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La Crosse, Wisconsin, United States, 54601
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Ciudad Autonoma de Buenos Aires, Argentina, 1180
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Ciudad Autónoma De Buenos Aires, Argentina
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Cordoba, Argentina, X5016
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Rosario, Argentina, 2000
Universidad Nacional De Rosario - Hospital Provincial Del Centenario Recruiting
Rosario, Argentina, 2000
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San Miguel de Tucuman, Argentina, 4000
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Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
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Liverpool, New South Wales, Australia, 2170
John Hunter Hospital and Hunter Medical Research Institute Recruiting
New Lambton Heights, New South Wales, Australia, 2305
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Royal Brisbane and Women's Hospital Not yet recruiting
Herston, Queensland, Australia, 4029
Coastal Digestive Health Recruiting
Maroorchydore, Queensland, Australia, 4558
University of the Sunshine Coast Recruiting
North Mackay, Queensland, Australia, 4740
Mater Adult Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
St Vincent's Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Harry Perkins Medical Research Institute, Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
St John of God Subiaco Hospital Recruiting
Subiaco, Western Australia, Australia, 6008
Australia
The Queen Elizabeth Hospital Recruiting
Woodville South, Australia, 5011
Austria
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
University Hospital St. Poelten Recruiting
St Polten, Austria, 3100
Medical University Vienna Recruiting
Vienna, Austria, 1090
Belarus
Vitebsk Regional Clinical Specialized Center Recruiting
Vitebsk, Belarus, 210604
Belgium
Algemeen Ziekenhuis Klina Recruiting
Brasschaat, Belgium, 2930
Universitair Ziekenhuis Brussel Not yet recruiting
Brussels, Belgium, 1090
Universitair Ziehenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Universitair Ziekenhuis Leuven, Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
CHC - Clinique St-Jospeh Recruiting
Liege, Belgium, 4000
Sart Tilman Hospital Department of Gastroenterology and Hepatology Recruiting
Seraing, Belgium, 4100
Hospital Centre of Walloon Picarde Recruiting
Tournai, Belgium, 7500
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska Recruiting
Banja Luka, Bosnia and Herzegovina, 78000
University Clinical Hospital Mostar Recruiting
Mostar, Bosnia and Herzegovina, 88000
Clinical Center University of Sarajevo Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Hospital Sao Rafael Not yet recruiting
Salvador, Bahia, Brazil, 41253-190
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda Not yet recruiting
Goiania, Goiás, Brazil, 74535-170
CDC - Centro Digestivo de Curitiba Not yet recruiting
Curitiba, Paraná, Brazil, 80430-180
Hospital Nossa Senhora das Gracas Not yet recruiting
Curitiba, Paraná, Brazil, 80810-040
Faculdade de Medicina de Botucatu Not yet recruiting
Botucatu, São Paulo, Brazil, 18618-970
CAEP - Centro Avancado de Estudos e Pesquisas Not yet recruiting
Campinas, São Paulo, Brazil, 13087-567
Universidade Federal de Sao Paulo-Hospital Not yet recruiting
San Paulo, São Paulo, Brazil, 04023
Pesquisare Saude Not yet recruiting
Santo Andre, São Paulo, Brazil, 09080-110
Kaiser Clinica Not yet recruiting
Sao Jose do Rio Preto, São Paulo, Brazil, 15015-110
Instituto De Assistencia Medica Ao Servidor Publico Estadual - Iamspe - Hspe/Fmo Not yet recruiting
Sao Paulo, São Paulo, Brazil, 04038-034
Santa Casa De Votuporanga-Philanthropic hospital Not yet recruiting
Votuporanga, São Paulo, Brazil, 15500-003
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo Not yet recruiting
Passo Fundo, Brazil, 99010
Hospital de Clinicas de Porto Alegre Not yet recruiting
Porto Alegre, RS, Brazil, 90035-003
Hospital Moinhos de Vento Not yet recruiting
Porto Alegre, Brazil, 90560-030
Ribeiralo Preto Medical School, University of Salo Paulo Not yet recruiting
Ribeirao Preto, Brazil, 14048-900
Universidade Federal do Estado do Rio de Janeiro (UNIRIO) - Hospital Universitario Gaffree e Guinle Not yet recruiting
Rio de Janeiro, Brazil, 20270-004
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF) Not yet recruiting
Rio de Janeiro, Brazil, 21941
CCBR Brasil Not yet recruiting
Rio de Janeiro, Brazil, 22271-100
CEMEC - Centro Multidisciplinar De Estudos Clanicos Not yet recruiting
Santo Andre, Brazil, 09190-510
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Not yet recruiting
Sao Jose do Rio Preto, Brazil, 15090
Faculdade de Medicina do ABC Not yet recruiting
Vila Sacadura Cabral, Brazil, 09060-870
CEDOES - Diagnostico e Pesquisa Not yet recruiting
Vitoria, Brazil, 29055-450
Bulgaria
Multiprofile Hospital for Active Treatment Medline Recruiting
Plovdiv, Bulgaria, 4002
MHAT Ruse AD Recruiting
Ruse, Bulgaria, 7002
Second MHAT Sofia AD Recruiting
Sofia, Bulgaria, 1202
Excelsior Medical Center Recruiting
Sofia, Bulgaria, 1407
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia Recruiting
Sofia, Bulgaria, 1407
Diagnostic and Consulting Center Alexandrovska Recruiting
Sofia, Bulgaria, 1431
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD Recruiting
Sofia, Bulgaria, 1527
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Recruiting
Sofia, Bulgaria, 1606
Diagnostic-Consultative Center Sveta Anna Not yet recruiting
Sofia, Bulgaria, 1709
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia Recruiting
Sofia, Bulgaria, 1784
ACIBADEM City Clinic Medical Center Bregalnitsa Recruiting
Varna, Bulgaria, 9002
Canada, Alberta
University of Calgary Health - The Gastrointestinal Research Group (GIRG) Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
West Edmonton Gastroenterology Consultants Not yet recruiting
Edmonton, Alberta, Canada, T5R1W2
Canada, British Columbia
Okanagan Clinical Trials Ltd Recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Fraser Clinical Trials Inc. Recruiting
New Westminister, British Columbia, Canada, V3L 3W5
Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
GI Research Institute Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
Brandon Medical Arts Clinic Recruiting
Brandon, Manitoba, Canada, R7A 0N7
Winnipeg Clinic Dermatology Research Recruiting
Winnipeg, Manitoba, Canada, R3CON2
Canada, Nova Scotia
Viable Clinical Research Recruiting
Bridgewater, Nova Scotia, Canada, B4V 3N2
IWK Health Center Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
London Health Sciences Centre, University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
LHSC Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Dr.Garisa Jagan Mohan Reddy MD Recruiting
Sudbury, Ontario, Canada, P3C 5K6
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Kensington Screening Clinic Not yet recruiting
Toronto, Ontario, Canada, M5T 3A9
Toronto Digestive Disease Associates Inc Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Hopital Maisonneuve-Rosemont Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
The Ottawa Hospital - General Campus Not yet recruiting
Ottawa, Quebec, Canada, K1H 8L6
Canada
Hospital For Sick Children Not yet recruiting
Toronto, Canada, M5G 1X8
China
Peking University First Hospital Not yet recruiting
Beijing, China, 100034
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University Not yet recruiting
Beijing, China, 100050
First Hospital of Jilin University Not yet recruiting
Changchun, China, 130021
Xiangya Hospital of Central South University Not yet recruiting
Changsha, China, 410008
Daping Hospital Third Military Medical University of People's Liberation Army Not yet recruiting
Chongqing, China, 630042
PLA Army General Hospital Not yet recruiting
Dongcheng District, China, 100700
Guangzhou First People's Hospital Not yet recruiting
Guangzhou Shi, China, 510180
Sun Yat-sen University - The Sixth Affiliated Hospital Not yet recruiting
Guangzhou Shi, China, 510655
Guangdong General Hospital Not yet recruiting
Guangzhou, China, 510030
Nanfang Hospital of Southern Medical University Not yet recruiting
Guangzhou, China, 510515
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 100142
The Second Affiliated Hospital of Zhejiang University School of Medicine Not yet recruiting
Hangzhou, China, 310009
The First Affiliated Hospital of Nanchang University Not yet recruiting
Nanchang, China, 330006
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University Not yet recruiting
Nanjing, China, 210029
Shanghai City theTenth People's Hospital Not yet recruiting
Shanghai City, China, 200072
Ruijin Hospital Shanghai Jiaotong University Not yet recruiting
Shanghai, China, 200025
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China, 200127
China Medical University Hospital Recruiting
Taichung City, China, 40447
RenMin Hospital Of Wuhan University Hubei General Hospital Not yet recruiting
Wuhan Shi, China, 430060
Wuhan Union Hospital Not yet recruiting
Wuhan, China, 430022
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Not yet recruiting
Wuhan, China, 430030
Xijing Hospital Not yet recruiting
Xian, China, 710000
Zhangzhou Municipal Hospital of Fujian Province Not yet recruiting
Zhangzhou, China, 363000
Croatia
Clinical Hospital Center Osijek Recruiting
Osijek, Croatia, 31000
Clinical Hospital Centre Rijeka Recruiting
Rijeka, Croatia, 51000
Clinical Hospital Center Split Recruiting
Split, Croatia, 21 000
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases Recruiting
Zagreb, Croatia, 10000
Clinical Hospital Dubrava Recruiting
Zagreb, Croatia, 10000
University Hospital Centre Zagreb, Clinic of Internal Diseases Recruiting
Zagreb, Croatia, 10000
Czechia
Military Hospital Brno Recruiting
Brno, Czechia, 615 00
St. Anne's University Hospital Brno Recruiting
Brno, Czechia, 656 91
Hepato-Gastroenterologie HK, s. r. o. Recruiting
Hradec Králové, Czechia, 500 12
Soukroma Gastroenterologicka ambulance a endoskopie Recruiting
Most, Czechia, 43401
PreventaMed Recruiting
Olomouc, Czechia, 77900
Krajská nemocnice Pardubice, Kožní oddelení Recruiting
Pardubice, Czechia, 532 03
University Hospital Pilsen Recruiting
Plzen, Czechia, 30460
University Hospital Motol Recruiting
Prague 5, Czechia, 150 06
Institut klinicke a experimentalni mediciny Recruiting
Praha 4, Czechia, 14021
IBD Centrum/ISCARE IVF a.s. Recruiting
Praha 7, Czechia, 17004
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Holbaek Hospital Recruiting
Holbaek, Denmark, 4300
Nykobing F Hospital Recruiting
Nykobing F, Denmark, 4800
Finland
Helsinki University Central Hospital (HUCH) Recruiting
Helsinki, Finland, 00290
Turku University Hospital Recruiting
Turku, Finland, 20520
Georgia
JSC Evex Medical Corporation - Batumi Referral Hospital Recruiting
Batumi, Georgia, 6010
JSC Evex Medical Corporation - Oncology Center Recruiting
Kutaisi, Georgia, 4600
LLC Vivamedi Recruiting
Tbilisi, Georgia, 0131
Tbilisi State Medical University Not yet recruiting
Tbilisi, Georgia, 0141
JSC Infectious Disease, AIDS and Clinical Immunology Research Center Recruiting
Tbilisi, Georgia, 0160
LTD Academician N.Kipshidze Central University Clinic Recruiting
Tbilisi, Georgia, 0160
LTD Aversi Clinic Recruiting
Tbilisi, Georgia, 0160
LTD MediClub Georgia Recruiting
Tbilisi, Georgia, 0160
David Tatishvili Medical Center Recruiting
Tbilisi, Georgia, 0186
JSC Evex Medical Corporation - Telavi Referral Hospital Recruiting
Telavi, Georgia, 2200
Germany
Gastroenterological Special Practice at Wittenbergplatz Not yet recruiting
Berlin, Germany, 10787
Gastroenterology Am Bayerischen Platz Recruiting
Berlin, Germany, 10825
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Charite - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 13353
DRK Clinics Berlin Recruiting
Berlin, Germany, 14050
Hospital Waldfriede e.V. Recruiting
Berlin, Germany, 14163
Brandenburg City Hospital Recruiting
Brandenburg an der Havel, Germany, 14770
Medical Care Unit Dachau Not yet recruiting
Dachau, Germany, 85221
Klinikum Darmstadt Not yet recruiting
Darmstadt, Germany, 64283
Kliniken Essen-Mitte Not yet recruiting
Essen, Germany, 45136
Johann Wolfgang Goethe University Hospital Not yet recruiting
Frankfurt am Main, Germany, 60590
Agaplesion Markus Krankenhaus Recruiting
Frankfurt, Germany, 60431
Interdisciplinary Crohn Colitis Center Rhein Main Recruiting
Frankfurt, Germany, 60594
Studiengesellschaft BSF Recruiting
Halle, Germany, 06108
University Hospital Halle (Saale) Recruiting
Halle, Germany, 06120
University Hospital Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Asklepios Klinik Hamburg Recruiting
Hamburg, Germany, 22559
Universitatsklinikum Schleswig-Holstein Not yet recruiting
Keil, Germany, 24105
Universitaetsklinikum Leipzig AoeR Recruiting
Leipzig, Germany, 04103
Practice for Gastroenterology and Internal Medicine Recruiting
Ludwigshafen am Rhein, Germany, 67067
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Recruiting
Mainz, Germany, 55131
University Hospital Muenster Recruiting
Muenster, Germany, 48149
Synesis Research Center Not yet recruiting
Munich, Germany, 80331
Robert-Bosch-Hospital Not yet recruiting
Stuttgart, Germany, 70376
Universitaetsklinikum Tuebingen Not yet recruiting
Tuebingen, Germany, 72076
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Greece
General Hospital of Athens Laikon Recruiting
Athens, Greece, 11527
Sotiria Chest Diseases Hospital of Athens Recruiting
Athens, Greece, 11527
Tzanio General Hospital of Piraeus Recruiting
Athens, Greece, 18536
PAGNI University Hospital Recruiting
Heraklion, Greece, 71110
General Hospital of Thessaloniki Hippokration Recruiting
Thessaloniki, Greece, 54642
424th Army General Hospital Recruiting
Thessaloniki, Greece, 56429
Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz Recruiting
Bekescsaba, Hungary, 5600
Magyar Honvedseg Egeszsegugyi Kozpont Recruiting
Budapest, Hungary, 1062
Szent Margit Korhaz Not yet recruiting
Budapest, Hungary, H-1032
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat Recruiting
Gyor, Hungary, 9024
CRU Hungary Kft Recruiting
Miskolc, Hungary, H-3529
Kanizsai Dorottya Hospital Recruiting
Nagykanizsa, Hungary, H-8800
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Recruiting
Szekesfehervar, Hungary, 8000
Clinfan Ltd Recruiting
Szekszárd, Hungary, 7100
Csongrad County Dr. Bugyi Istvan Hospital Recruiting
Szentes, Hungary, 6600
Zala Megyei KorhazHaematologia Not yet recruiting
Zalaegerszeg, Hungary, 8900
Ireland
St Vincent's University Hospital Recruiting
Dublin 4, Dublin, Ireland
Beaumont Hospital Recruiting
Dublin 9, Ireland
Israel
Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center Recruiting
Afula, Israel, 18341
Bat Yamon Medical Center, Clalit Medical Services Recruiting
Bat Yam, Israel, 5962025
Asaf Harofeh Medical Center Recruiting
Beer Jacob, Israel, 73100
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Clalit Health Services Recruiting
Jerusalem, Israel, 9362410
Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Galilee Medical Center Recruiting
Nahariya, Israel, 22100
The Nazareth Hospital E.M.M.S. Not yet recruiting
Nazareth, Israel, 16100
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Kaplan Medical Center Recruiting
Rechovot, Israel, 76100
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Italy
University Polyclinic Hospital of Bari Not yet recruiting
Bari, Italy, 70124
Polyclinic S. Orsola-Malpighi Not yet recruiting
Bologna, Italy, 40138
Civil Hospital of Brescia Recruiting
Brescia, Italy, 25123
University Hospital Mater Domini Recruiting
Catanzaro, Italy, 88100
"Ss. Annunziata" Policlinic of Chieti Recruiting
Chieti, Italy, 66100
University Polyclinic Hospital G. Martino Recruiting
Messina, Italy, 98125
Maggiore Polyclinic Hospital, IRCCS Ca' Granda Recruiting
Milano, Italy, 20122
Humanitas Research Hospital - Humanitas Mirasole S.p.A Recruiting
Milan, Italy, 20089
Local Healthcare Company of Monza ASST Monza Recruiting
Monza, Italy, 20900
Hospital of Di Padova Not yet recruiting
Padova, Italy, 35128
United Hospitals Villa Sofia Cervello Recruiting
Palermo, Italy, 90146
Polyclinic San Matteo IRCCS Not yet recruiting
Pavia, Italy, 27100
Polyclinic Tor Vergata Recruiting
Roma, Italy, 00133
Univerisity Polyclinic Foundation Agostino Gemelli Recruiting
Roma, Italy, 00168
Azienda Ospedaliera San Camillo Forlanini Recruiting
Rome, Italy, 00152
Integrated University Hospital Santa Maria della Misericordia of Udine Recruiting
Udine, Italy, 33100
A.O. Universitaria Fondazione Macchi Recruiting
Varese, Italy, 21100
Sacred Heart Don Calabria Recruiting
Verona, Italy, 37024
Korea, Republic of
Korea University Medical Center - Korea University Ansan Hospital Recruiting
Ansan, Korea, Republic of, 152-703
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 612-030
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 705-030
Hanyang University Guri Hospital Recruiting
Guri-si, Korea, Republic of, 11923
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of, 13620
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 3080
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 3181
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 7985
St. Vincent's Hospital Recruiting
Suwon, Korea, Republic of, 442723
Latvia
P. Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV-1002
Digestive Diseases Center Gastro Recruiting
Riga, Latvia, LV-1006
Riga East Clinical University Hospital clinic Gailezers Recruiting
Riga, Latvia, LV-1038
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Recruiting
Kaunas, Lithuania, LT-50009
Klaipeda University Hospital Recruiting
Klaipeda, Lithuania, LT-5808
Vilnius University Hospital Santariskes Clinics Recruiting
Vilnius, Lithuania, 08406
Vilnius University Hospital Santariskiu Klinikos Recruiting
Vilnius, Lithuania, LT-08661
Vilnius City Clinical Hospital Recruiting
Vilnius, Lithuania, LT-10207
Mexico
Hospital Dalinde - CECRA Clinica Especializada en Colon, Recto y Ano Not yet recruiting
Delegacion Cuauhtemoc, Distrito Federal, Mexico, 06760
Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V. Recruiting
Zapapan, Jalisco, Mexico, 45030
Centro Regiomontano de Estudios Clinicos Roma SC. Recruiting
Monterrey, Nuevo León, Mexico, 64610
Instituto Tecnológico y de Estudios Superiores de Monterrey Recruiting
Monterrey, Nuevo León, Mexico, 64718
SMIQ Recruiting
Santiago de Queretaro, Querétaro, Mexico, 76070
Hospital Christus Muquerza del Parque S.A. de C.V. Not yet recruiting
Chihuahua, Mexico
Centro de Investigacion Clinica Acelerada (CICA) S.C. Recruiting
Mexico, Mexico, 07020
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Not yet recruiting
Tlalpan, Mexico, 14080
Moldova, Republic of
"Sfanta Treime" Clinical Municipal Hospital, Department of Proctology Recruiting
Chisinau, Moldova, Republic of, MD-2068
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery Recruiting
Chisinau, Moldova, Republic of, MD2005
"Sf. Arhanghel Mihail" Municipal Clinical Hospital Recruiting
Chisinau, Moldova, Republic of, MD2025
Republican Clinical Hospital, Department of Colorectal Surgery Recruiting
Chisinau, Moldova, Republic of, MD2025
Republican Clinical Hospital, Department of Gastroenterology Recruiting
Chisinau, Moldova, Republic of, MD2025
Netherlands
Vrije Universiteit Medisch Centrum (VUMC) Recruiting
Amsterdam, Netherlands, 1081 HV
Academisch Medisch Centrum Not yet recruiting
Amsterdam, Netherlands, 1105 AZ
UMC Groningen Recruiting
Groningen, Netherlands, 9713 GZ
University Hospital Maastricht Not yet recruiting
Maastricht, Netherlands, 6229 HX
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6525 GA
Zuyderland Medisch Centrum Recruiting
Sittard-Geleen, Netherlands, 6162 BG
St. Elisabeth Ziekenhuis Recruiting
Tilburg, Netherlands, 5022 GC
Norway
Akershus University Hospital Not yet recruiting
Lørenskog, Norway, 1478
Lovisenberg Diakonale Sykehus Not yet recruiting
Oslo, Norway, 0440
Poland
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego Recruiting
Bialystok, Poland, 15-276
Medical Services Center MaxMed Recruiting
Bochnia, Poland, 32-700
St. John Paul 2nd Municipal Hospital in Elblag Recruiting
Elblag, Poland, 82-300
Private Medical Practice Miroslaw Fic Recruiting
Jelenia Gora, Poland, 58-500
BioVirtus Medical Centre Recruiting
Jozefow, Poland, 05-410
Nzoz All-Medicus Recruiting
Katowice, Poland, 40-660
Kornel Gibinski Independent Public Central Clinical Hospital in Katowice Recruiting
Katowice, Poland, 40-752
GLOBE Clinical Research Sp. z o.o. LLC Recruiting
Klodzko, Poland, 57-300
PLEJADY Sp. z o.o. (LLC) Medical Centre Recruiting
Krakow, Poland, 30-363
LUX MED Centrum Medyczne - Krakow Not yet recruiting
Krakow, Poland, 30-392
Landa Specialist Doctor's Offices Recruiting
Krakow, Poland, 31-156
Krakow Medical Center LLC Recruiting
Krakow, Poland, 31-501
Centrum Opieki Zdrowotnej Orkan Med Recruiting
Ksawerow, Poland, 95-054
Santa Familia Centrum Badan, Profilaktyki i Leczenia Recruiting
Lodz, Poland, 90-302
Salve Medica Recruiting
Lodz, Poland, 91-211
LUX MED Centrum Medyczne - Lodz Recruiting
Lodz, Poland, 93-034
1 Military Clinical Hospital in Lublin Recruiting
Lublin, Poland, 20-049
Provincial Specialist Hospital in Olsztyn Recruiting
Olsztyn, Poland, 10-561
SOLUMED Medical Center Recruiting
Poznan, Poland, 60-529
Endoskopia Sp. z o.o. Recruiting
Sopot, Poland, 81-756
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC Recruiting
Szczecin, Poland, 71-270
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe Recruiting
Torun, Poland, 87-100
H-T. Medical Center Sp. z o.o. LLC Limited Partnership Recruiting
Tychy, Poland, 43-100
Polimedica Recruiting
Ul. Piotrkowska 177, Poland, 90-447
Maternal Pediatric and Adolescent Healthcare Centre Recruiting
Warsaw, Poland, 00-632
PRIMA LCC Specialist Clinics Recruiting
Warsaw, Poland, 02-018
Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1 Recruiting
Warszawa, Poland, 02-653
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Recruiting
Warszawa, Poland, 03-580
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice Recruiting
Wierzchoslawice, Poland, 33-122
LUX MED Centrum Medyczne - Wroclaw Recruiting
Wroclaw, Poland, 50-053
Wroclaw Medical University Recruiting
Wroclaw, Poland, 50-367
Clinical Research Center Early-Phase Research Facility Recruiting
Wroclaw, Poland, 51-162
LexMedica Recruiting
Wroclaw, Poland, 53-114
Ars Medica Recruiting
Wroclaw, Poland, 53-333
EMC Medical Institute S.A Recruiting
Wroclaw, Poland, 54-144
Portugal
Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra Not yet recruiting
Coimbra, Portugal, 3000-075
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes Recruiting
Guimaraes, Portugal, 4835-044
Hospital Beatriz Angelo Not yet recruiting
Loures, Portugal, 2674-514
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE Recruiting
Viana do Castelo, Portugal, 4904-858
Romania
Hyperclinica MedLife Grivita Recruiting
Bucharest, Romania, 010719
Dr. Carol Davila Central Military Emergency Clinical Hospital Recruiting
Bucharest, Romania, 010825,
Fundeni Clinical Institute Not yet recruiting
Bucharest, Romania, 022328
Bucharest University Emergency Hospital, Department of Internal Medicine II Recruiting
Bucharest, Romania, 050098
Center of Diagnosis and Treatment Provita Not yet recruiting
Bucharest, Romania
Craiova County Emergency Clinical Hospital Recruiting
Craiova, Romania, 200642
Colentina Clinical Hospital Recruiting
Napoca, Romania, 400001
Targu Mures County Emergency Clinical Hospital Recruiting
Targu Mures, Romania, 540136
Russian Federation
Joint Venture Company Diagnostic Center, Bioterm Ltd. Not yet recruiting
Barnaul, Russian Federation, 656015
Territorial Clinical Hospital Recruiting
Barnaul, Russian Federation, 656024
Regional Clinical Hospital #3 Recruiting
Chelyabinsk, Russian Federation, 454021
Chelyabinsk Regional Clinical Hospital Recruiting
Chelyabinsk, Russian Federation, 454076
Ural State Medical Academy - Medical Association Novaya Bolnitsa Not yet recruiting
Ekaterinburg, Russian Federation, 620109
Irkutsk State Medical Academy of Postgraduate Education Recruiting
Irkutsk, Russian Federation, 664049
Immanuel Kant Baltic Federal University Not yet recruiting
Kaliningrad, Russian Federation, 236016
Kaluga Regional Hospital Recruiting
Kaluga, Russian Federation, 248007
Kemerovo State Medical Academy of Roszdrav Recruiting
Kemerovo, Russian Federation, 650066
Moscow Clinical Scientific and Practical Center Recruiting
Moscow, Russian Federation, 111123
City Clinical Hospital n.a. V.M. Buyanov Recruiting
Moscow, Russian Federation, 115516
City Clinical Hospital 24 Recruiting
Moscow, Russian Federation, 117997
CJSC Nasledniki Recruiting
Moscow, Russian Federation, 119192
A.N. Ryzhikh State Research Center for Coloproctology Recruiting
Moscow, Russian Federation, 123423
Railway Station Clinical Hospital Recruiting
Nizhny Novgorod, Russian Federation, 603140
Medical Center Sibnovomed LLC Recruiting
Novosibirsk, Russian Federation, 630091
Scientific Research Institute of Physiology and Basic Medicine Recruiting
Novosibirsk, Russian Federation, 630117
Euromed Multi-Specialty Center for Contemporary Medicine LLC Recruiting
Omsk, Russian Federation, 644024
Medical Diagnostic Center LLC Recruiting
Orenburg, Russian Federation, 460050
N.N. Burdenko Penza Regional Clinical Hospital Not yet recruiting
Penza, Russian Federation, 440026
Republican Hospital na VA Baranov Recruiting
Petrozavodsk, Russian Federation, 185019
Evromedservis Recruiting
Pushkin, Russian Federation, 196603
Clinic UZI 4D, LLC Recruiting
Pyatigorsk, Russian Federation, 357502
Pyatigorsk City Hospital 2 Recruiting
Pyatigorsk, Russian Federation, 357538
Rostov State Medical University Recruiting
Rostov-on-Don, Russian Federation, 344022
Medical Center Reavita Med Spb LLC Recruiting
Saint Petersburg, Russian Federation, 194354
City Clinical Hospital No 31 - St. Petersburg Recruiting
Saint Petersburg, Russian Federation, 197110
S.M. Kirov Military Medical Academy Recruiting
Saint-Petersburg, Russian Federation, 194044
Medical University REAVIZ Recruiting
Samara, Russian Federation, 443001
Samara Station Railway Clinical Hospital under OAO Russian Railways Recruiting
Samara, Russian Federation, 443041
Regional Clinical Hospital Recruiting
Saratov, Russian Federation, 410053
Sochi City Hospital No 5 Recruiting
Sochi, Russian Federation, 354207
S.M. Kirov Military Medical Academy Not yet recruiting
St Petersburg, Russian Federation, 194044
Oncology Center of Moskovskiy District Recruiting
St Petersburg, Russian Federation, 196247
City Outpatient Care Unit No 38 Recruiting
St. Petersburg, Russian Federation, 191015
I.I. Mechnikov North-Western State Medical University Recruiting
St. Petersburg, Russian Federation, 191015
State Unitary Enterprise Passengeravtotrans Recruiting
St. Petersburg, Russian Federation, 195009
Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office Recruiting
St. Petersburg, Russian Federation, 195067
SPb SBIH City Hospital of Saint Martyr Elizaveta Recruiting
St. Petersburg, Russian Federation, 195257
Medical Center ItanoMed Not yet recruiting
St. Petersburg, Russian Federation, 196128
Medical Center Eko-Bezopasnost LLC Recruiting
St. Petersburg, Russian Federation, 196143
SPb SBIH City Hospital # 9 Not yet recruiting
St. Petersburg, Russian Federation, 197110
Tomsk Regional Clinical Hospital Recruiting
Tomsk, Russian Federation, 634063
G.G. Kuvatov Republican Clinical Hospital Recruiting
Ufa, Russian Federation, 450005
City Clinical Hospital #21 Recruiting
Ufa, Russian Federation, 450071
Novgorod Regional Clinical Hospital Recruiting
Veliky Novgorod, Russian Federation, 173008
Primorsky Regional Clinical Hospital No.1 Recruiting
Vladivostok, Russian Federation, 690091
Medical Scientific Manufacturing Association Dvizheniye Clinic Recruiting
Volgograd, Russian Federation, 400107
Saudi Arabia
King Fahad Specialist Hospital Not yet recruiting
Dammam, Saudi Arabia, 32253
King Abdul Aziz University Hospital Not yet recruiting
Jeddah, Saudi Arabia, 22252
King Saud Medical Complex Not yet recruiting
Riyadh, Saudi Arabia, 12746
King Fahad National Guard Hospital Not yet recruiting
Riyadh, Saudi Arabia, 14611
Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine Recruiting
Belgrade, Serbia, 11 080
Clinical Hospital Center Zvezdara Clinic of Internal Diseases Recruiting
Belgrade, Serbia, 11000
Military Medical Academy, Clinic of Gastroenterology and Hepatology Recruiting
Belgrade, Serbia, 11000
Clinical Center Kragujevac Recruiting
Kragujevac, Serbia, 34000
Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology Recruiting
Novi Sad, Serbia, 21 000
General Hospital Pancevo Recruiting
Pancevo, Serbia, 260 00
General Hospital Djordje Jovanovic Zrenjanin Recruiting
Zrenjanin, Serbia, 23 000
Slovakia
Cliniq, s.r.o. Recruiting
Bratislava, Slovakia, 820 07
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Recruiting
Bratislava, Slovakia, 82606
Brezno gastroenterology center s.r.o. Recruiting
Brezno, Slovakia, 97701
KM Management, spol. s r.o. Recruiting
Nitra, Slovakia, 94901
Gastromedic s.r.o. Recruiting
Nove Zamky, Slovakia, 94002
GASTRO I., s.r.o. Recruiting
Presov, Slovakia, 080 01
World of the Health Inc. General Hospital Rimavska Sobota Recruiting
Rimavska Sobota, Slovakia, 979 01
Slovenia
General Hospital Celje Recruiting
Celje, Slovenia, 3000
General Hospital Novo Mesto Not yet recruiting
Novo Mesto, Slovenia, 8000
South Africa
Ahmed Kathrada Private Hospital Recruiting
Gauteng, South Africa, 1820
Emmed Research Recruiting
Pretoria, South Africa, 0084
Spain
General University Hospital of Alicante Recruiting
Alicante, Spain, 03010
University Hospital Germans Trias i Pujol Recruiting
Badalona, Spain, 08916
Teknon Medical Center Recruiting
Barcelona, Spain, 08022
University Hospital Reina Sofia Recruiting
Cordoba, Spain, 14001
University Hospital of Girona Dr. Josep Trueta Recruiting
Girona, Spain, 17007
University Hospital of the Canary Islands (HUC) La Laguna Not yet recruiting
La Laguna, Spain, 38320
Gran Canaria Dr Negrin University Hospital Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35012
University Hospital de La Princesa Recruiting
Madrid, Spain, 28006
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
University Hospital La Paz Recruiting
Madrid, Spain, 28046
University Hospital Puerta de Hierro Majadajonda Recruiting
Majadahonda, Madrid, Spain, 28222
University Hospital Marques de Valdecilla (HUMV) Recruiting
Santander, Spain, 39008
University Hospital Virgen Macarena Recruiting
Sevilla, Spain, 41009
University Hospital Virgen del Rocio Recruiting
Sevilla, Spain, 41013
University Clinical Hospital of Valencia Recruiting
Valencia, Spain, 46010
Viladecans Hospital Recruiting
Viladecans, Spain, 08840
University Hospital Miguel Servet Not yet recruiting
Zaragoza, Spain, 50009
Sweden
Saint Goran Hospital Recruiting
Stockholm, Sweden, 112 81
Ersta Hospital Not yet recruiting
Stockholm, Sweden, 116 91
Switzerland
Lindenhofspital Recruiting
Bern, Switzerland, 3001
Cantonal Hospital Saint Gallen Recruiting
St.Gallen, Switzerland, 9007
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, San Ming Dist., Taiwan, 807
E-DA Hospital Recruiting
Kaohsiung, Taiwan, 82445
Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi Recruiting
Kozlu, Taiwan, 67000
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital Not yet recruiting
Niao-Sung Hsiang Kaohsiung County, Taiwan, 83301
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taiana, Taiwan, 704
Chang Gung Memorial Hospital- Linkou Recruiting
Taoyuan City, Taiwan, 33305
Taipei Veterans General Hospital Recruiting
Tapei, Beitou Dist., Taiwan, 11217
National Taiwan University Hospital Not yet recruiting
Tapei, Taiwan, 10002
Turkey
Hacettepe Universitesi Recruiting
Ankara, Turkey, 01660
Ankara University Medical Faculty Cebeci Hospital Recruiting
Ankara, Turkey, 06590
Uludag Universitesi Tip Fakultesi Recruiting
Bursa, Turkey, 16059
Firat University Medical Faculty Recruiting
Elazig, Turkey, 23119
Bezmialem Foundation University Medical Faculty Recruiting
Istanbul, Turkey, 34093
Istanbul University Cerrahpasa Medical Faculty Recruiting
Istanbul, Turkey, 34098
Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi Recruiting
Istanbul, Turkey, 34668
Marmara University Recruiting
Istanbul, Turkey, 34840
Istanbul Medeniyet Uni Goztepe Training&Res Hosp Recruiting
Istanbul, Turkey, 34854
Izmir Medical Park Hastanesi Not yet recruiting
Karsiyaka, Turkey, 35000
Kocaeli Derince Training and Research Hospital Recruiting
Kocaeli, Turkey, 41380
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi Recruiting
Trabzon, Turkey, 61080
Ukraine
Chernivtsi Regional Clinical Hospital Recruiting
Chernivtsi, Ukraine, 58001
Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2 Not yet recruiting
Dnipropetrovsk, Ukraine, 49027
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases Recruiting
Dnipropetrovsk, Ukraine, 49074
Ivano-Frankivsk Regional Clinical Hospital Recruiting
Ivano-Frankivsk, Ukraine, 76008
Ivano-Frankivsk Central City Clinical Hospital Recruiting
Ivano-Frankivsk, Ukraine, 76018
V.T. Zaitsev Institute of General and Emergency Surgery Recruiting
Kharkiv, Ukraine, 61018
Kharkiv City Clinical Hospital 2 Recruiting
Kharkiv, Ukraine, 61037
Khmelnytskyi Regional Hospital Recruiting
Khmelnytskyi, Ukraine, 29000
Medical and Diagnostic Center Acinus Recruiting
Kropyvnytskyi, Ukraine, 25006
Medical Center Medical Clinic Blagomed LLC Not yet recruiting
Kyiv, Ukraine, 01023
Kyiv City Clinical Hospital #18 Not yet recruiting
Kyiv, Ukraine, 01030
BIK-KYIV Ukrainian German Gastroenterology Center Recruiting
Kyiv, Ukraine, 01601
Medical Center Consilium Medical Recruiting
Kyiv, Ukraine, 02000
Ok Clinic Medical Center within International Institute of Clinical Trials, LLC Recruiting
Kyiv, Ukraine, 02175
Kyiv Regional Hospital #2 Recruiting
Kyiv, Ukraine, 04053
Kyiv Regional Clinical Hospital Recruiting
Kyiv, Ukraine, 04107
Volyn Regional Clinical Hospital Not yet recruiting
Lutsk, Ukraine, 43005
Lviv Regional Clinical Hospital Recruiting
Lviv, Ukraine, 79010
Public City Clinical Hospital of Emergency Medical Care Recruiting
Lviv, Ukraine, 79059
Ternopil City Public Emergency Medical Care Hospital Recruiting
Ternopil, Ukraine, 46008
Vinnytsia City Clinical Hospital #1 Not yet recruiting
Vinnytsia, Ukraine, 02029
Vinnytsia M.I. Pyrohov Regional Clinical Hospital Recruiting
Vinnytsia, Ukraine, 21018
Vinnytsia M.I. Pyrohov Regional Clinical Hospital Not yet recruiting
Vinnytsia, Ukraine, 21018
Health Clinic, LLC Recruiting
Vinnytsya, Ukraine, 21009
Zaporizhzhya Regional Recruiting
Zaporizhzhya, Ukraine, 69600
First Private Clinic Not yet recruiting
Zhytomyr, Ukraine, 10003
United Kingdom
Bristol Royal Infirmary Recruiting
Bristol, United Kingdom, BS2 8HW
Ulster Hospital Not yet recruiting
Dundonald, United Kingdom, BT16 1RH
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Victoria Hospital Blackpool Recruiting
Lancashire Blackpool, United Kingdom, FY3 8NR
Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
John Radcliffe Hospital Not yet recruiting
Oxford, United Kingdom, OX3 9DU
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Torbay Hospital Recruiting
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Jerry Liu, MD Celgene

Additional Information:
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03464097     History of Changes
Other Study ID Numbers: RPC01-3203
U1111-1203-8002 ( Registry Identifier: WHO )
2017-004294-14 ( EudraCT Number )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Crohn's Disease
Crohn Disease
Oral
Ozanimod
Moderately active
Severely active
RPC01
RPC01-3203

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases