Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
Primary Purpose
Inflammatory Bowel Disease, Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Balsalazide disodium
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- mildly to moderately active ulcerative colitis.
- disease extends at least 20 cm from the rectum.
- baseline MMDAI score between 6-10, inclusive, and greater than or equal to 2 on the MMDAI bleeding component and endoscopy/sigmoidoscopy component.
- not taking more than 4.8 grams/day of Asacol, greater than or equal to 6.75 grams/day of Colazal,or 2.4 grams/day of mesalamine or equivalent daily dose using any other 5-ASA products at any time during the 14 days preceding the initiation of study medication.
- if of childbearing potential, negative serum pregnancy test.
Exclusion Criteria:
- subject has a significant medical, including psychiatric, condition which in the opinion of the investigator precludes participation in the study.
- subject has a history of allergy or intolerance to aspirin, mesalamine, or other salicylates.
- subject's UC has worsened or failed to improve during chronic (i.e., at least 7) therapy with greater than or equal to 6.6 g/day days of balsalazide disodium within 30 days of screening
- subject has received chronic (i.e., greater than 15 consecutive days) of immunosuppressive therapy (e.g. azathioprine, 6 mercaptopurine) or corticosteroids within 30 days of screening. Intermittent use of oral or rectal immunosuppressive therapy or corticosteroids within 30 days of screening is permitted. Intravenous use of corticosteroids within 30 days of screening is not permitted.
- subject has received intra-rectal aminosalicylates for greater than 2 consecutive days within 7 days of screening.
- subject has had any prior bowel surgery, except appendectomy or cholecystectomy.
- subject has participated in an investigational drug or device study within the 30 days prior to study.
- subject is pregnant or at risk of pregnancy, or is lactating (female subjects only).
- subject shows evidence of current excessive alcohol consumption or drug dependence.
- subject has a history of human immunodeficiency virus (HIV). Subjects with history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.
- subject has other infectious, ischemic, or immunologic diseases with GI involvement.
- subject has twice the upper limit of normal (ULN) for any of the following LFTs: alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), alkaline phosphatase, or total bilirubin (except isolated elevation of unconjugated bilirubin).
- subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULN of serum creatinine.
- subject has calculated creatinine clearance level of less than or equal to 60 mL/min.
- subject has unstable cardiovascular, coagulopathy or pulmonary disease characterized by a worsening in the disease condition that required a change in treatment or medical care within one (1) month of randomization.
- subject has active malignancy within the last 5 years, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
- subject has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
- subject has sclerosing cholangitis.
- subject has positive stool culture for ovum and parasites (O&P) or C. difficile.
- subject has been treated with infliximab, cyclosporine, natalizumab, or methotrexate for ulcerative colitis within the last 30 days prior to screening.
- regular use of NSAIDS except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
- subject has received cell-depleting therapies such as the Adacolumn.
- subject requires antidiarrheal therapy during screening.
- subject has clinical or radiographic findings suggestive of serious UC complications such as toxic megacolon or colonic perforation.
Sites / Locations
- Premiere Pharmaceutical Research
- Arizona Clinical Research Center
- Medical Services of Northwest Arkansas
- Gastroenterology Associates
- AGMG Clinical Research Institute
- West Gastroenterology Medical Group
- Sharp Rees-Stealy Medical Group
- Rocky Mountain Gastroenterology
- Arapahoe Gastroenterology, PC
- South Denver Gastroenterology
- Phoenix Internal Medical Associates
- Clinical Trials Management of Bocal Raton
- Research Consultants Group
- Horizon Institute for Clinical Researcg
- Mark Lamet, M.D.
- Borland-Grover Clinic
- A+ Research
- West Wind'r Research & Development
- Shafran Gastroenterology Center
- Florida Medical Clinic
- The Atlanta Center for Gastroenterology
- Atlanta Gastroenterology Associates
- Atlanta Academic Research
- Gastroenterology Associates of Central Georgia
- Digestive Research Associates
- University of Illinois at Chicago
- Carle Clinic Association
- Community Clinical Research Center
- Iowa Digestive Disease Center
- University of Kentucky Medical Center
- Clinical Trials Management
- Digestive Disorders Association
- Maryland Clinical Trials
- Alan Rosen, M.D.
- Digestive Disease Associates
- Chevy Chase Clinical Research
- The Center for Clinical Research
- Charm City Research
- Coastal Research Associates
- Gastroenterology Associates of Western Michigan
- Borgess Research Institute
- Henry Ford West Bloomfield
- Gastrointestinal Associates
- Center for Digestive and Liver Diseases
- The GI Group of South Jersey
- University of New Mexico
- Long Island Clinical
- New York Center for Clinical Research
- Winthrop University Hospital
- Reseach Associates of NY
- Simon Lichtiger, M.D.
- Asheville Gastroenterology
- Charlotte Gastroenterology & Hematology, PLLC
- Carolina Digestive Health Associates
- Northwest Piedmont Clinical Research
- Carolina Research Center
- East Carolina Gastroenterology
- Wake Research Associates, LLC
- Hanover Medical Specialists, PA
- Wilmington Gastroenterology Associates
- Digestive Health Specialists
- Gastroenterology Specialists Inc.
- Digestive Health Network
- Gastrointestinal & Liver Diseases Consultants, PC
- AvamarCenter for Endoscopy
- Sooner Clinical Research
- Gastroenterology United of Tulsa
- West Hills Gastroenterology
- Penn State Milton S. Hershey Medical Center
- Thomas Jefferson University
- Guthrie
- Charleston Gastroenterology Center
- MUSC Digestive Disease Center
- Clin Search
- ACE Research Specialists
- Gastrointestinal Instititute PLLC
- Nashville Medical Research Institute
- Austin Gastroenterology
- Houston Digestive Diseases Clinci
- Houston Medical Research Associates
- North Texas Gastroenterology
- Gastroenterology Clinic of San Antonio
- Advanced Research Institute
- Gastroenterology Associates of Tidewater
- Liver and Digestive Disease Specialists
- McGuire VAMC
- Discovery Research International
- Wisconsin Center for Advanced Research
Outcomes
Primary Outcome Measures
The primary efficacy endpoint is the proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of six weeks of therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT00408174
First Posted
December 4, 2006
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00408174
Brief Title
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
Official Title
A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
5. Study Description
Brief Summary
To establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 6 weeks of therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis
Keywords
IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Balsalazide disodium
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is the proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of six weeks of therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mildly to moderately active ulcerative colitis.
disease extends at least 20 cm from the rectum.
baseline MMDAI score between 6-10, inclusive, and greater than or equal to 2 on the MMDAI bleeding component and endoscopy/sigmoidoscopy component.
not taking more than 4.8 grams/day of Asacol, greater than or equal to 6.75 grams/day of Colazal,or 2.4 grams/day of mesalamine or equivalent daily dose using any other 5-ASA products at any time during the 14 days preceding the initiation of study medication.
if of childbearing potential, negative serum pregnancy test.
Exclusion Criteria:
subject has a significant medical, including psychiatric, condition which in the opinion of the investigator precludes participation in the study.
subject has a history of allergy or intolerance to aspirin, mesalamine, or other salicylates.
subject's UC has worsened or failed to improve during chronic (i.e., at least 7) therapy with greater than or equal to 6.6 g/day days of balsalazide disodium within 30 days of screening
subject has received chronic (i.e., greater than 15 consecutive days) of immunosuppressive therapy (e.g. azathioprine, 6 mercaptopurine) or corticosteroids within 30 days of screening. Intermittent use of oral or rectal immunosuppressive therapy or corticosteroids within 30 days of screening is permitted. Intravenous use of corticosteroids within 30 days of screening is not permitted.
subject has received intra-rectal aminosalicylates for greater than 2 consecutive days within 7 days of screening.
subject has had any prior bowel surgery, except appendectomy or cholecystectomy.
subject has participated in an investigational drug or device study within the 30 days prior to study.
subject is pregnant or at risk of pregnancy, or is lactating (female subjects only).
subject shows evidence of current excessive alcohol consumption or drug dependence.
subject has a history of human immunodeficiency virus (HIV). Subjects with history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.
subject has other infectious, ischemic, or immunologic diseases with GI involvement.
subject has twice the upper limit of normal (ULN) for any of the following LFTs: alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), alkaline phosphatase, or total bilirubin (except isolated elevation of unconjugated bilirubin).
subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULN of serum creatinine.
subject has calculated creatinine clearance level of less than or equal to 60 mL/min.
subject has unstable cardiovascular, coagulopathy or pulmonary disease characterized by a worsening in the disease condition that required a change in treatment or medical care within one (1) month of randomization.
subject has active malignancy within the last 5 years, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
subject has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
subject has sclerosing cholangitis.
subject has positive stool culture for ovum and parasites (O&P) or C. difficile.
subject has been treated with infliximab, cyclosporine, natalizumab, or methotrexate for ulcerative colitis within the last 30 days prior to screening.
regular use of NSAIDS except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
subject has received cell-depleting therapies such as the Adacolumn.
subject requires antidiarrheal therapy during screening.
subject has clinical or radiographic findings suggestive of serious UC complications such as toxic megacolon or colonic perforation.
Facility Information:
Facility Name
Premiere Pharmaceutical Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Medical Services of Northwest Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Gastroenterology Associates
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
AGMG Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
West Gastroenterology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Rocky Mountain Gastroenterology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Arapahoe Gastroenterology, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
South Denver Gastroenterology
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Phoenix Internal Medical Associates
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Clinical Trials Management of Bocal Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Research Consultants Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Horizon Institute for Clinical Researcg
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mark Lamet, M.D.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Borland-Grover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
A+ Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
West Wind'r Research & Development
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Florida Medical Clinic
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
The Atlanta Center for Gastroenterology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Academic Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Digestive Research Associates
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
80120
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Digestive Disorders Association
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Maryland Clinical Trials
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Alan Rosen, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Digestive Disease Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
The Center for Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Charm City Research
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Coastal Research Associates
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Henry Ford West Bloomfield
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Gastrointestinal Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Center for Digestive and Liver Diseases
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
The GI Group of South Jersey
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Long Island Clinical
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York Center for Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Reseach Associates of NY
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Simon Lichtiger, M.D.
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Asheville Gastroenterology
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Charlotte Gastroenterology & Hematology, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Northwest Piedmont Clinical Research
City
Elkin
State/Province
North Carolina
ZIP/Postal Code
28621
Country
United States
Facility Name
Carolina Research Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
East Carolina Gastroenterology
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wilmington Gastroenterology Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Digestive Health Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Gastroenterology Specialists Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Digestive Health Network
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Gastrointestinal & Liver Diseases Consultants, PC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
AvamarCenter for Endoscopy
City
Warren
State/Province
Ohio
ZIP/Postal Code
44484
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Gastroenterology United of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
West Hills Gastroenterology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Guthrie
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Charleston Gastroenterology Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
MUSC Digestive Disease Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Clin Search
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
ACE Research Specialists
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Gastrointestinal Instititute PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Austin Gastroenterology
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Houston Digestive Diseases Clinci
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Houston Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
North Texas Gastroenterology
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Gastroenterology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Liver and Digestive Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
McGuire VAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Discovery Research International
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
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