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Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Encapsulated Mesalamine Granules (eMG)
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring UC, Ulcerative colitis, Inflammatory bowel disease, IBD

Eligibility Criteria

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

Inclusion Criteria: An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities. Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new participants: a. Participant is a male or, If the participant is female, she is eligible to enter if she is of: Non-childbearing potential (that is; physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); or childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following: i) Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 6-month Treatment Phase, and the 2-week follow-up phase. ii) Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study. iii) An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than (<)1% per year (not all IUDs meet this criterion). iv) Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion. v) Partner has undergone vasectomy and participant is in a monogamous relationship. The investigator is responsible for determining whether the participant has adequate birth control for study participation. b. Participant is greater than or equal to (≥) 18 years of age. c. Participant has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed participants) of mild to moderate UC in remission for greater than (>) 1 month and <12 months. d. Confirmed current remission defined as both: A screening rectal bleeding score of 0 as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the (Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 = Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage. Participant and investigator consider there is the potential for benefit to the participant with MP treatment. Participant is capable and willing to comply with all study procedures. Exclusion Criteria: Participant 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. If a new participant, the following additional exclusion criteria will apply: Participant has a history of allergy or intolerance to aspirin, mesalamine or other salicylates. Participant has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent participant's enrollment in the study. Participant or participant's parents are known to have phenylketonuria. Participant has participated in an investigational drug or device study within the 30 days prior to study screening. Participant shows evidence of current excessive alcohol consumption or drug dependence. Participant has uncontrolled, clinically significant renal disease manifested by 1.5 * ULN of serum creatinine or blood urea nitrogen (BUN) levels. Participant has calculated creatinine clearance level of <60 mL/min

Sites / Locations

  • Birmingham Gastroenterology Associates
  • First Care Family Doctors South
  • Little Rock Diagnostic Clinic
  • AGMG Clinical Research
  • Lovelace Scientific Resources
  • Digestive Liver Disease Specialists, Medical Group
  • Long Beach VA Medical Center
  • Community Clinical Trials
  • Rider Research Group
  • John Jolley, M.D.
  • Lovelace Scientific Resources
  • Santa Barbara Clinical Research
  • Professionals for Clinical Research
  • Connecticut Gastroenterology Institute
  • Clinical Research of Tampa Bay, Inc.
  • Medical Research Unlimited
  • Southern Clinical Research Consultants
  • United Medical Research
  • Venture Research Institute, LLC
  • Penninsula Research, Inc.
  • Advanced Gastroenterology Associates
  • Lovelace Scientific Resources
  • Advent Clinical Research
  • Metabolic Research Institute, Inc.
  • Consultative Gastroenterology
  • Digestive Care Associates
  • Center for Gastroenterology
  • Gastroenterology Associates of Central Georgia
  • Northwest Gastroenterologists S.C.
  • Covenant Clinic
  • Cotton-O'Neil Digestive Health Center
  • University of Louisville
  • Sinai Medical Office Building
  • Philip J. Beam Medical Center
  • Research Institute of Michigan, LLC
  • Center for Digestive & Liver Diseases
  • St. Louis Center for Clinical Research
  • Shore Health Group
  • Simon Lichtiger, M.D.
  • VA Medical Center, Northport
  • VA Medical Center
  • Upstate Gastroenterology Associates, PC
  • LeBauer Research Associates, PA
  • Bethany Medical Center
  • Boice-Willis Clinic
  • Consultants for Clinical Research, Inc.
  • Avamar Center for Endoscopy
  • Oklahoma Gastroenterology Associates, LLC
  • Charleston Gastroenterology Specialists, LLC
  • Hillcrest Clinical Research, LLC
  • Medical Research Institute
  • NationsMed Clinical Research
  • Clinical Trial Network
  • Houston Digestive Disease Clinic
  • Gastroenterology Associates of Tidewater
  • New River Research Institute
  • Seattle Gastroenterology Associates
  • Eastern Washington Clinical Research Center
  • Spokane Digestive Disease Center
  • Digestive Disease Research Center
  • Center for Advanced Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Encapsulated Mesalamine Granules (eMG)

Arm Description

Participants will receive eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Number of Participants Who Prematurely Discontinued Treatment
Number of participants who prematurely discontinued treatment due to any reason were reported.
Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities
Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter [g/dL]): <10 and ≥3 decrease, or >20; hematocrit (%): <30 and ≥10 decrease, or >60; platelets (*10^9 cells/liter): <100 or >700 (normal: 150-400); white blood cells (*10^9 cells/liter): <2.3 or >16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter [U/L]): ≥3 * upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): ≥3 * ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter [µmol/L]): >2 times; and calcium creatinine clearance (milliliters/minute [mL/min]): ≤50.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2006
Last Updated
October 14, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00326209
Brief Title
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
Official Title
A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 22, 2005 (Actual)
Primary Completion Date
May 5, 2008 (Actual)
Study Completion Date
May 5, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

5. Study Description

Brief Summary
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.
Detailed Description
This is a Phase 3, multicenter, open-label, treatment extension study evaluating the long-term safety and tolerability of eMG given once daily (QD) in participants who successfully participated in a double-blind lead-in study (MPUC3003 [NCT00744016 ] or MPUC3004 [NCT00767728 ]) or new participants who are currently in remission from symptoms of ulcerative colitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
UC, Ulcerative colitis, Inflammatory bowel disease, IBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Encapsulated Mesalamine Granules (eMG)
Arm Type
Experimental
Arm Description
Participants will receive eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months.
Intervention Type
Drug
Intervention Name(s)
Encapsulated Mesalamine Granules (eMG)
Other Intervention Name(s)
Mesalamine pellets
Intervention Description
eMG capsules will be administered per dose and schedule specified in the arm.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame
Baseline (Day 1) up to follow-up (24.5 months)
Title
Number of Participants Who Prematurely Discontinued Treatment
Description
Number of participants who prematurely discontinued treatment due to any reason were reported.
Time Frame
Baseline up to Month 24
Title
Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities
Description
Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter [g/dL]): <10 and ≥3 decrease, or >20; hematocrit (%): <30 and ≥10 decrease, or >60; platelets (*10^9 cells/liter): <100 or >700 (normal: 150-400); white blood cells (*10^9 cells/liter): <2.3 or >16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter [U/L]): ≥3 * upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): ≥3 * ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter [µmol/L]): >2 times; and calcium creatinine clearance (milliliters/minute [mL/min]): ≤50.
Time Frame
Baseline up to follow-up (24.5 months)
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Description
Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.
Time Frame
Baseline, up to follow-up visit (Month 24.5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities. Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new participants: a. Participant is a male or, If the participant is female, she is eligible to enter if she is of: Non-childbearing potential (that is; physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); or childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following: i) Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 6-month Treatment Phase, and the 2-week follow-up phase. ii) Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study. iii) An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than (<)1% per year (not all IUDs meet this criterion). iv) Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion. v) Partner has undergone vasectomy and participant is in a monogamous relationship. The investigator is responsible for determining whether the participant has adequate birth control for study participation. b. Participant is greater than or equal to (≥) 18 years of age. c. Participant has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed participants) of mild to moderate UC in remission for greater than (>) 1 month and <12 months. d. Confirmed current remission defined as both: A screening rectal bleeding score of 0 as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the (Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 = Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage. Participant and investigator consider there is the potential for benefit to the participant with MP treatment. Participant is capable and willing to comply with all study procedures. Exclusion Criteria: Participant 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. If a new participant, the following additional exclusion criteria will apply: Participant has a history of allergy or intolerance to aspirin, mesalamine or other salicylates. Participant has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent participant's enrollment in the study. Participant or participant's parents are known to have phenylketonuria. Participant has participated in an investigational drug or device study within the 30 days prior to study screening. Participant shows evidence of current excessive alcohol consumption or drug dependence. Participant has uncontrolled, clinically significant renal disease manifested by 1.5 * ULN of serum creatinine or blood urea nitrogen (BUN) levels. Participant has calculated creatinine clearance level of <60 mL/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Mathew
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Gastroenterology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
First Care Family Doctors South
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States
Facility Name
Little Rock Diagnostic Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
AGMG Clinical Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Lovelace Scientific Resources
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Digestive Liver Disease Specialists, Medical Group
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Long Beach VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rider Research Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
John Jolley, M.D.
City
San Rafael
State/Province
California
ZIP/Postal Code
94901
Country
United States
Facility Name
Lovelace Scientific Resources
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Santa Barbara Clinical Research
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States
Facility Name
Professionals for Clinical Research
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Clinical Research of Tampa Bay, Inc.
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Medical Research Unlimited
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Southern Clinical Research Consultants
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Venture Research Institute, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Penninsula Research, Inc.
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Advanced Gastroenterology Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Lovelace Scientific Resources
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Advent Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Consultative Gastroenterology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Digestive Care Associates
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Center for Gastroenterology
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
Northwest Gastroenterologists S.C.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Covenant Clinic
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Cotton-O'Neil Digestive Health Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Sinai Medical Office Building
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Philip J. Beam Medical Center
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive & Liver Diseases
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Shore Health Group
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
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
VA Medical Center, Northport
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
VA Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Upstate Gastroenterology Associates, PC
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
LeBauer Research Associates, PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Bethany Medical Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Boice-Willis Clinic
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Consultants for Clinical Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Avamar Center for Endoscopy
City
Warren
State/Province
Ohio
ZIP/Postal Code
44484
Country
United States
Facility Name
Oklahoma Gastroenterology Associates, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Charleston Gastroenterology Specialists, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Hillcrest Clinical Research, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
NationsMed Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Houston Digestive Disease Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
New River Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Seattle Gastroenterology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Eastern Washington Clinical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Spokane Digestive Disease Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Digestive Disease Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26563167
Citation
Lichtenstein GR, Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP. Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. Dig Dis Sci. 2016 Jan;61(1):221-9. doi: 10.1007/s10620-015-3866-7. Epub 2015 Nov 12.
Results Reference
derived

Learn more about this trial

Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

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