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Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Budesonide MMX®

Placebo

5-ASA

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis

Eligibility Criteria

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

Inclusion Criteria:

Age 18 to 75 years, inclusive.
Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
Active mild or moderate UC with an ulcerative colitis disease activity index (UCDAI) score ≥4 and ≤10, with a mucosal appearance score of ≥1, and physician's rating of disease activity of 1 or 2.
Experiencing active UC (flare) despite a therapeutic dose of an oral 5-ASA (for example, mesalamine ≥2.4 g/day for ≥6 weeks prior to randomization, or equivalent). At screening, photographic evidence of active UC based on mucosal appearance must be obtained.
Women of childbearing potential or men of reproductive potential must be willing to use an acceptable form of contraception.
Able to comprehend the full nature and purpose of the study, including possible risks and side effects, and also able to comply with all requirements of the study. Must be able to understand and voluntarily sign an informed consent prior to any study procedures.

Exclusion Criteria:

Limited distal proctitis (from anal verge to 15 centimeters [cm] above the pectineal line).
Severe UC (UCDAI >10 or physician global assessment [PGA] >2), or non-active UC (UCDAI <4).
Infectious colitis or any recent history of infectious colitis (within 30 days of Screening).
Active malignancy or carcinoma in situ within the last 5 years (treated non-melanoma skin cancers are not exclusionary).
Active ulcer or bleeding disorder that may affect evaluation of blood in the stool.
Evidence or history of toxic megacolon or bowel resection.
Crohn's disease or indeterminate colitis.
Known hypersensitivity to budesonide or any ingredients of the budesonide MMX tablets.
Active tuberculosis or other active systemic or local bacterial, fungal, or viral infection.
Liver cirrhosis, evident hepatic or renal disease or insufficiency, or significant impairment of the biohumoral parameters (≥2.5*upper limit of normal [ULN] for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or ≥2*ULN for creatinine). Elevations in bilirubin due to benign conditions such as Gilbert's syndrome are not exclusionary.
Severe diseases in other organs or systems.
Local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents.
Type 1 diabetes.
Glaucoma or with a family history of glaucoma in first-degree relatives.
Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according to the local privacy policy.
Severe anemia (<9 g/deciliter [dL] hemoglobin), leukopenia (<2.5*10^9 white blood cells [WBC]/liter [L]), or granulocytopenia (<1.2*10^9 cells/L).
Participants with a history of pancolitis (disease that extends to the hepatic flexure or beyond) for ≥8 years or left-sided colitis (disease confined to the left colon [that is, distal to the splenic flexure]) ≥15 years who have not yet completed a surveillance colonoscopy for dysplasia/colorectal cancer screening within the past year.
Prior budesonide MMX treatment.
Use of oral corticosteroids including other budesonide formulations within the last 4 weeks prior to randomization.
Use of any rectal 5-ASA or corticosteroid formulations within the last 2 weeks prior to randomization.
Use of immunosuppressive agents within the last 8 weeks prior to randomization.
Use of anti-tumor necrosis factor-alpha (TNFα) agents or other biologic therapies within the last 3 months prior to randomization.
Participation in experimental therapeutic studies within 30 days of randomization (or within the last 3 months if in an anti-TNFα or biologic agent study). Note: participants who participated in observational-only studies (and who did not receive study therapy) are not excluded.
Any other medical condition that, in the Principal Investigator's opinion, would make the administration of the study drug or study procedures hazardous to the participant or obscure the interpretation of adverse events (AEs) by the appropriate independent ethics committee/institutional review board.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Budesonide MMX

Placebo

Arm Description

Participants will receive 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician.

Participants will receive 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician.

Outcomes

Primary Outcome Measures

Number of Participants Who Achieved Clinical Remission at Day 56

Clinical remission defined as a score of 0 for rectal bleeding and 0 for stool frequency components from the Ulcerative Colitis Disease Activity Index (UCDAI). UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis. Participants who had clinical remission at Baseline were classified as non-responders.

Secondary Outcome Measures

Number of Participants of Who Achieved Clinical Response at Day 56

Clinical response defined as an improvement in UCDAI from Baseline of ≥3 points with a rectal bleeding score ≤1. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Rectal bleeding was based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

Number of Participants Who Achieved UCDAI Remission at Day 56

UCDAI remission was defined as a total UCDAI score ≤1 with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance of the colon. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

Number of Participants Who Achieved Endoscopic Remission at Day 56

Endoscopic remission was defined as a score of 0 in the mucosal appearance component subscore of the UCDAI at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Mucosal appearance was based on endoscopy results. If the mucosal appearance subscore could not be calculated because of missing data, endoscopic remission was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

Number of Participants Who Achieved Histologic Healing at Day 56

Participants achieved histologic healing if histologic assessments of all biopsy specimens were graded as 0 (normal mucosa). If the score for ≥1 sample was missing, the overall score at that visit was set to missing. Participants with insufficient data at Day 56 were excluded from analysis.

Number of Participants With Treatment Failure at Day 56

Treatment failure was defined as an unchanged, worsened, or missing UCDAI score at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding was based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

Change From Baseline in Inflammatory Bowel Disease-Quality of Life (IBD-QoL) Questionnaire Scores

The IBD-QoL questionnaire was self-completed by the participant. The IBD-QoL is a disease-specific instrument to evaluate the quality of life of participants with UC. This 32-item questionnaire has 4 dimensions: bowel function, emotional function, systemic symptoms, and social function. The total score is presented, which ranges from 32 to 224, with higher scores indicating a better quality of life. The scores of participants in remission usually range from 170 to 190. If >50% of the questionnaire answers for a particular dimension were missing, this dimension score was set to missing. The total score for the IBD-QoL was the sum of the domain scores, however, if any dimension score was missing, the total IBD-QoL score was set to missing.

Full Information

NCT ID

NCT01532648

First Posted

December 13, 2011

Last Updated

August 15, 2019

Sponsor

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01532648

Brief Title

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 27, 2012 (Actual)

Primary Completion Date

October 2, 2013 (Actual)

Study Completion Date

October 2, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

Detailed Description

Eligible participants will be randomized to 1 of the following 2 treatment arms: Budesonide MMX 9 mg (1 tablet) Placebo (tablet indistinguishable from budesonide MMX 9 mg tablet) The assigned study drug will be taken as a single oral tablet each morning after breakfast. In addition to the study drug, all participants will continue their existing background oral 5-ASA regimen during the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

510 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Budesonide MMX

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Budesonide MMX®

Other Intervention Name(s)

Budesonide Multi-Matrix System

Intervention Description

Oral tablet taken daily in the morning after breakfast.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.

Intervention Type

Drug

Intervention Name(s)

5-ASA

Intervention Description

Acceptable oral 5-ASA medications to be received during the study include: Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g) Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g

Primary Outcome Measure Information:

Title

Number of Participants Who Achieved Clinical Remission at Day 56

Description

Time Frame

Baseline up to Day 56

Secondary Outcome Measure Information:

Title

Number of Participants of Who Achieved Clinical Response at Day 56

Description

Time Frame

Baseline up to Day 56

Title

Number of Participants Who Achieved UCDAI Remission at Day 56

Description

Time Frame

Baseline up to Day 56

Title

Number of Participants Who Achieved Endoscopic Remission at Day 56

Description

Time Frame

Screening and Day 56

Title

Number of Participants Who Achieved Histologic Healing at Day 56

Description

Time Frame

Baseline and Day 56

Title

Number of Participants With Treatment Failure at Day 56

Description

Time Frame

Baseline up to Day 56

Title

Change From Baseline in Inflammatory Bowel Disease-Quality of Life (IBD-QoL) Questionnaire Scores

Description

Time Frame

Baseline, Days 14, 28, and 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 75 years, inclusive. Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings. Active mild or moderate UC with an ulcerative colitis disease activity index (UCDAI) score ≥4 and ≤10, with a mucosal appearance score of ≥1, and physician's rating of disease activity of 1 or 2. Experiencing active UC (flare) despite a therapeutic dose of an oral 5-ASA (for example, mesalamine ≥2.4 g/day for ≥6 weeks prior to randomization, or equivalent). At screening, photographic evidence of active UC based on mucosal appearance must be obtained. Women of childbearing potential or men of reproductive potential must be willing to use an acceptable form of contraception. Able to comprehend the full nature and purpose of the study, including possible risks and side effects, and also able to comply with all requirements of the study. Must be able to understand and voluntarily sign an informed consent prior to any study procedures. Exclusion Criteria: Limited distal proctitis (from anal verge to 15 centimeters [cm] above the pectineal line). Severe UC (UCDAI >10 or physician global assessment [PGA] >2), or non-active UC (UCDAI <4). Infectious colitis or any recent history of infectious colitis (within 30 days of Screening). Active malignancy or carcinoma in situ within the last 5 years (treated non-melanoma skin cancers are not exclusionary). Active ulcer or bleeding disorder that may affect evaluation of blood in the stool. Evidence or history of toxic megacolon or bowel resection. Crohn's disease or indeterminate colitis. Known hypersensitivity to budesonide or any ingredients of the budesonide MMX tablets. Active tuberculosis or other active systemic or local bacterial, fungal, or viral infection. Liver cirrhosis, evident hepatic or renal disease or insufficiency, or significant impairment of the biohumoral parameters (≥2.5*upper limit of normal [ULN] for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or ≥2*ULN for creatinine). Elevations in bilirubin due to benign conditions such as Gilbert's syndrome are not exclusionary. Severe diseases in other organs or systems. Local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents. Type 1 diabetes. Glaucoma or with a family history of glaucoma in first-degree relatives. Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according to the local privacy policy. Severe anemia (<9 g/deciliter [dL] hemoglobin), leukopenia (<2.5*10^9 white blood cells [WBC]/liter [L]), or granulocytopenia (<1.2*10^9 cells/L). Participants with a history of pancolitis (disease that extends to the hepatic flexure or beyond) for ≥8 years or left-sided colitis (disease confined to the left colon [that is, distal to the splenic flexure]) ≥15 years who have not yet completed a surveillance colonoscopy for dysplasia/colorectal cancer screening within the past year. Prior budesonide MMX treatment. Use of oral corticosteroids including other budesonide formulations within the last 4 weeks prior to randomization. Use of any rectal 5-ASA or corticosteroid formulations within the last 2 weeks prior to randomization. Use of immunosuppressive agents within the last 8 weeks prior to randomization. Use of anti-tumor necrosis factor-alpha (TNFα) agents or other biologic therapies within the last 3 months prior to randomization. Participation in experimental therapeutic studies within 30 days of randomization (or within the last 3 months if in an anti-TNFα or biologic agent study). Note: participants who participated in observational-only studies (and who did not receive study therapy) are not excluded. Any other medical condition that, in the Principal Investigator's opinion, would make the administration of the study drug or study procedures hazardous to the participant or obscure the interpretation of adverse events (AEs) by the appropriate independent ethics committee/institutional review board.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lindsey Mathew

Organizational Affiliation

Bausch Health Companies

Official's Role

Study Director

Facility Information:

Facility Name

Santarus Clinical Investigational Site 1043

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Santarus Clinical Investigational Site 1071

City

Lakewood

State/Province

California

ZIP/Postal Code

90712

Country

United States

Facility Name

Santarus Clinical Investigational Site 1003

City

San Diego

State/Province

California

ZIP/Postal Code

92114

Country

United States

Facility Name

Santarus Clinical Investigational Site 1063

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

Santarus Clinical Investigational Site 1028

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Santarus Clinical Investigational Site 1035

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33426

Country

United States

Facility Name

Santarus Clinical Investigational Site 1045

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Santarus Clinical Investigational Site 1001

City

Largo

State/Province

Florida

ZIP/Postal Code

33777

Country

United States

Facility Name

Santarus Clinical Investigational Site 1024

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Santarus Clinical Investigational Site 1029

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Santarus Clinical Investigational Site 1010

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Santarus Clinical Investigational Site 1002

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Santarus Clinical Investigational Site 1050

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Santarus Clinical Investigational Site 1075

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Santarus Clinical Investigational Site 1065

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

Santarus Clinical Investigational Site 1058

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Santarus Clinical Investigational Site 1032

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Santarus Clinical Investigational Site 1044

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

Santarus Clinical Investigational Site 1016

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Santarus Clinical Investigational Site 1081

City

Novi

State/Province

Michigan

ZIP/Postal Code

48377

Country

United States

Facility Name

Santarus Clinical Investigational Site 1015

City

Wyoming

State/Province

Michigan

ZIP/Postal Code

49159

Country

United States

Facility Name

Santarus Clinical Investigational Site 1068

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Santarus Clinical Investigational Site 1074

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Santarus Clinical Investigational Site 1061

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Santarus Clinical Investigational Site 1021

City

Cheektowaga

State/Province

New York

ZIP/Postal Code

14225

Country

United States

Facility Name

Santarus Clinical Investigational Site 1072

City

Great Neck

State/Province

New York

ZIP/Postal Code

11023

Country

United States

Facility Name

Santarus Clinical Investigational Site 1031

City

New York

State/Province

New York

ZIP/Postal Code

10028

Country

United States

Facility Name

Santarus Clinical Investigational Site 1073

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28403

Country

United States

Facility Name

Santarus Clinical Investigational Site 1080

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Santarus Clinical Investigational Site 1078

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Santarus Clinical Investigational Site 1082

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45415

Country

United States

Facility Name

Santarus Clinical Investigational Site 1064

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17604

Country

United States

Facility Name

Santarus Clinical Investigational Site 1006

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Santarus Clinical Investigational Site 1059

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Santarus Clinical Investigational Site 1039

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Santarus Clinical Investigational Site 1005

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77505

Country

United States

Facility Name

Santarus Clinical Investigational Site 1014

City

Lancaster

State/Province

Utah

ZIP/Postal Code

84341

Country

United States

Facility Name

Santarus Clinical Investigational Site 1038

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Santarus Clinical Investigational Site 1025

City

Christiansburg

State/Province

Virginia

ZIP/Postal Code

24073

Country

United States

Facility Name

Santarus Clinical Investigational Site 4003

City

Pleven

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4004

City

Plovdiv

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4009

City

Plovdiv

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4008

City

Ruse

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4001

City

Sofia

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4002

City

Sofia

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4005

City

Sofia

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4007

City

Sofia

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4010

City

Sofia

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 4011

City

Sofia

Country

Bulgaria

Facility Name

Santarus Clinical Investigational Site 2003

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A1R9

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2008

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2004

City

London

State/Province

Ontario

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2010

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2002

City

Vaughan

State/Province

Ontario

ZIP/Postal Code

L4L4Y7

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2009

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2001

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1G2E8

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2007

City

Calgary

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2005

City

London

Country

Canada

Facility Name

Santarus Clinical Investigational Site 2006

City

Quebec

Country

Canada

Facility Name

Santarus Clinical Investigational Site 3001

City

Hradec Kralove

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3006

City

Hradec Kralove

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3005

City

Labem

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3003

City

Olomouc

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3009

City

Prague

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3004

City

Praha

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3007

City

Praha

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3002

City

Tabor

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3010

City

Usti nad Orlici

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 3011

City

Valasske Mezirici

Country

Czechia

Facility Name

Santarus Clinical Investigational Site 8001

City

Tallinn

Country

Estonia

Facility Name

Santarus Clinical Investigational Site 5010

City

Bekescsaba

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5008

City

Budapest

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5009

City

Budapest

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5001

City

Debrecen

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5003

City

Gyula

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5004

City

Kaposvar

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5002

City

Miskolc

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5006

City

Mosonmagyarovar

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5011

City

Pecs

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5005

City

Szeged

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 5007

City

Vac

Country

Hungary

Facility Name

Santarus Clinical Investigational Site 8101

City

Riga

Country

Latvia

Facility Name

Santarus Clinical Investigational Site 8102

City

Riga

Country

Latvia

Facility Name

Santarus Clinical Investigational Site 8103

City

Riga

Country

Latvia

Facility Name

Santarus Clinical Investigational Site 8202

City

Kaunas

Country

Lithuania

Facility Name

Santarus Clinical Investigational Site 8201

City

Vilnius

Country

Lithuania

Facility Name

Santarus Clinical Investigational Site 8203

City

Vilnius

Country

Lithuania

Facility Name

Santarus Clinical Investigational Site 6003

City

Elblag

Country

Poland

Facility Name

Santarus Clinical Investigational Site 6001

City

Krakow

Country

Poland

Facility Name

Santarus Clinical Investigational Site 6002

City

Sopot

Country

Poland

Facility Name

Santarus Clinical Investigational Site 6006

City

Szczecin

Country

Poland

Facility Name

Santarus Clinical Investigational Site 6004

City

Warszawa

Country

Poland

Facility Name

Santarus Clinical Investigational Site 6008

City

Warszawa

Country

Poland

Facility Name

Santarus Clinical Investigational Site 6005

City

Warszawy

Country

Poland

Facility Name

Santarus Clinical Investigational Site 9016

City

Lipetsk

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9005

City

Moscow

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9010

City

Moscow

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9004

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9003

City

Ryazan

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9008

City

Saint Petersburg

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9013

City

Saint Petersburg

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9014

City

Saint Petersburg

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9009

City

Saratov

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9001

City

St Petersburg

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9007

City

Stavropol

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9006

City

Ufa

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 9017

City

Volgograd

Country

Russian Federation

Facility Name

Santarus Clinical Investigational Site 7010

City

Crimea

Country

Ukraine

Facility Name

Santarus Clinical Investigational Site 7002

City

Donetsk

Country

Ukraine

Facility Name

Santarus Clinical Investigational Site 7001

City

Kharkiv

Country

Ukraine

Facility Name

Santarus Clinical Investigational Site 7004

City

Kharkiv

Country

Ukraine

Facility Name

Santarus Clinical Investigational Site 7006

City

Kyiv

Country

Ukraine

Facility Name

Santarus Clinical Investigational Site 7008

City

Kyiv

Country

Ukraine

Facility Name

Santarus Clinical Investigational Site 7005

City

Vinnytsia

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

28333362

Citation

Rubin DT, Cohen RD, Sandborn WJ, Lichtenstein GR, Axler J, Riddell RH, Zhu C, Barrett AC, Bortey E, Forbes WP. Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial. J Crohns Colitis. 2017 Jul 1;11(7):785-791. doi: 10.1093/ecco-jcc/jjx032. Erratum In: J Crohns Colitis. 2017 Dec 4;11(12):1510.

Results Reference

derived

Learn more about this trial

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

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Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Ulcerative Colitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial