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Completed Phase 3 Interventional Results available

Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

ClinicalTrials.gov ID: NCT01951326

Public ClinicalTrials.gov record NCT01951326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Study identification

NCT ID
NCT01951326
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
RedHill Biopharma Limited
Industry
Enrollment
331 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2013 (Type not available)
Primary completion
May 2018 (Actual)
Completion
Aug 2019 (Actual)
Last update posted
Dec 8, 2020

2013 – 2019

United States locations

U.S. sites
43
U.S. states
18
U.S. cities
40
Facility City State ZIP Site status
Del Sol Research Management, 850 N Knob Road Tucson Arizona 85710 —
Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303 Anaheim California 92801 —
Medvin Clinical Research, 15627 Imperial Highway, La Mirada California 90638 —
Digestive Care Associates, Inc., 1000 Laurel St. San Carlos California 94070 —
Ventura Clinical Trials, 1835 Knoll Drive Ventura California 93003 —
Medical Research Center of Connecticut, LLC Hamden Connecticut 06518 —
Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330 Aventura Florida 33180 —
Clinical Research of West Florida Clearwater Florida 33765 —
Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111 Lauderdale Lakes Florida 33319 —
Gastroenterology Group of Naples, 1064 Goodlette Road Naples Florida 34102 —
Advanced Research Institute Inc., 7114 Congress Street New Port Richey Florida 34653 —
Endoscopic Research, Inc., 1817 North Mills Avenue Orlando Florida 32802 —
Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110 Port Orange Florida 32127 —
Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550 Decatur Georgia 30033 —
Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300 Marietta Georgia 30060 —
Rush University Medical Center Chicago Illinois 60612 —
The Carle Foundation, 611 West Park Street Urbana Illinois 61801 —
Cotton-O'Neil Clinical Research Center, 720 SW Lane St. Topeka Kansas 66606 —
Investigative Clinical Research, 612 Ridgely Avenue, Suite 401, Annapolis Maryland 21401 —
Chevy Chase Clinical Research, 5550 Friendship Blvd. Chevy Chase Maryland 20815 —
Commonwealth Clinical Studies, 189 Quincy St. Brockton Massachusetts 02302-2926 —
Center For Digestive Health Troy Michigan 48098 —
West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201 Wyoming Michigan 49519 —
Ehrhardt Clinical Research, LLC, 108 Congress Street Belton Missouri 64012 —
AGA Clinical Research Associates, Inc., 3205 Fire Road Egg Harbor New Jersey 08324 —
Holy Name Medical Center, 718 Teaneck Road Teaneck New Jersey 07666 —
North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111 Great Neck New York 11021 —
NYU Langone Long Island , 1000 Northern Boulevard, Suite 160 Great Neck New York 11021 —
Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor New York New York 10016 —
Montefiore Medical Center, 111 East 210th Street The Bronx New York 10467 —
University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg. Chapel Hill North Carolina 27599 —
Ohio GI and Liver Institute, 2925 Vernon Place 100 Cincinnati Ohio 45219 —
Ohio GI and Liver Institute Cincinnati Ohio 45249 —
ClinSearch, 6035 Shallowford Road, Suite 109 Chattanooga Tennessee 37421 —
Brooke Army Medical Center, 3551 Roger Brooke Drive Fort Sam Houston Texas 78284 —
Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor Houston Texas 77030 —
University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234 Houston Texas 77030 —
Spring Gastroenterology Associates, 8901 FM 1960 West Humble Texas 77036 —
DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106 Richardson Texas 75082 —
Digestive Disease Center, 621 Camden Street, Suite 202 San Antonio Texas 78215 —
Tyler Research Institute, 1720 S. Beckham Tyler Texas 75701 —
Gasteroenterology Associates of Northern Virgina, 3028 Javier Road Fairfax Virginia 22031 —
McGuire DVAMC, 1201 Broad Rock Boulevard Richmond Virginia 23249 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01951326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 8, 2020 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01951326 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →