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)

NCT01532648 | Completed Phase 3 Results

• 1 other identifier: C2011-0401
• Study Type: interventional
• Target: 510
• Locations: 11 countries
• Sites: 114

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).

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to Day 56

Secondary Outcomes (6)

• Number of Participants of Who Achieved Clinical Response at Day 56

  Baseline up to Day 56

• Number of Participants Who Achieved UCDAI Remission at Day 56

  Baseline up to Day 56

• Number of Participants Who Achieved Endoscopic Remission at Day 56

  Screening and Day 56

• Number of Participants Who Achieved Histologic Healing at Day 56

  Baseline and Day 56

• Number of Participants With Treatment Failure at Day 56

  Baseline up to Day 56

Study Arms (2)

Budesonide MMX

EXPERIMENTAL

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.

Drug: Budesonide MMX®; Drug: 5-ASA

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: 5-ASA

Interventions

Budesonide MMX® DRUG

Oral tablet taken daily in the morning after breakfast.

Also known as: Budesonide Multi-Matrix System

Budesonide MMX

Placebo DRUG

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

Placebo

5-ASA DRUG

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

Budesonide MMX; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years, inclusive.
• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (114)

Santarus Clinical Investigational Site 1043

Anaheim, California, 92801, United States

Location

Santarus Clinical Investigational Site 1071

Lakewood, California, 90712, United States

Location

Santarus Clinical Investigational Site 1003

San Diego, California, 92114, United States

Location

Santarus Clinical Investigational Site 1063

Littleton, Colorado, 80120, United States

Location

Santarus Clinical Investigational Site 1028

Bristol, Connecticut, 06010, United States

Location

Santarus Clinical Investigational Site 1035

Boynton Beach, Florida, 33426, United States

Location

Santarus Clinical Investigational Site 1045

Jacksonville, Florida, 32256, United States

Location

Santarus Clinical Investigational Site 1001

Largo, Florida, 33777, United States

Location

Santarus Clinical Investigational Site 1024

Maitland, Florida, 32751, United States

Location

Santarus Clinical Investigational Site 1029

Port Orange, Florida, 32127, United States

Location

Santarus Clinical Investigational Site 1010

Winter Park, Florida, 32789, United States

Location

Santarus Clinical Investigational Site 1002

Zephyrhills, Florida, 33613, United States

Location

Santarus Clinical Investigational Site 1050

Decatur, Georgia, 30033, United States

Location

Santarus Clinical Investigational Site 1075

Chicago, Illinois, 60637, United States

Location

Santarus Clinical Investigational Site 1065

Oak Lawn, Illinois, 60453, United States

Location

Santarus Clinical Investigational Site 1058

Indianapolis, Indiana, 46202, United States

Location

Santarus Clinical Investigational Site 1032

Shreveport, Louisiana, 71103, United States

Location

Santarus Clinical Investigational Site 1044

Annapolis, Maryland, 21401, United States

Location

Santarus Clinical Investigational Site 1016

Chesterfield, Michigan, 48047, United States

Location

Santarus Clinical Investigational Site 1081

Novi, Michigan, 48377, United States

Location

Santarus Clinical Investigational Site 1015

Wyoming, Michigan, 49159, United States

Location

Santarus Clinical Investigational Site 1068

Ypsilanti, Michigan, 48197, United States

Location

Santarus Clinical Investigational Site 1074

Rochester, Minnesota, 55905, United States

Location

Santarus Clinical Investigational Site 1061

Lebanon, New Hampshire, 03756, United States

Location

Santarus Clinical Investigational Site 1021

Cheektowaga, New York, 14225, United States

Location

Santarus Clinical Investigational Site 1072

Great Neck, New York, 11023, United States

Location

Santarus Clinical Investigational Site 1031

New York, New York, 10028, United States

Location

Santarus Clinical Investigational Site 1073

Wilmington, North Carolina, 28403, United States

Location

Santarus Clinical Investigational Site 1080

Cincinnati, Ohio, 45267, United States

Location

Santarus Clinical Investigational Site 1078

Cleveland, Ohio, 44195, United States

Location

Santarus Clinical Investigational Site 1082

Dayton, Ohio, 45415, United States

Location

Santarus Clinical Investigational Site 1064

Lancaster, Pennsylvania, 17604, United States

Location

Santarus Clinical Investigational Site 1006

Sayre, Pennsylvania, 18840, United States

Location

Santarus Clinical Investigational Site 1059

Austin, Texas, 78705, United States

Location

Santarus Clinical Investigational Site 1039

Houston, Texas, 77030, United States

Location

Santarus Clinical Investigational Site 1005

Pasadena, Texas, 77505, United States

Location

Santarus Clinical Investigational Site 1014

Lancaster, Utah, 84341, United States

Location

Santarus Clinical Investigational Site 1038

Chesapeake, Virginia, 23320, United States

Location

Santarus Clinical Investigational Site 1025

Christiansburg, Virginia, 24073, United States

Location

Santarus Clinical Investigational Site 4003

Pleven, Bulgaria

Location

Santarus Clinical Investigational Site 4004

Plovdiv, Bulgaria

Location

Santarus Clinical Investigational Site 4009

Plovdiv, Bulgaria

Location

Santarus Clinical Investigational Site 4008

Rousse, Bulgaria

Location

Santarus Clinical Investigational Site 4001

Sofia, Bulgaria

Location

Santarus Clinical Investigational Site 4002

Sofia, Bulgaria

Location

Santarus Clinical Investigational Site 4005

Sofia, Bulgaria

Location

Santarus Clinical Investigational Site 4007

Sofia, Bulgaria

Location

Santarus Clinical Investigational Site 4010

Sofia, Bulgaria

Location

Santarus Clinical Investigational Site 4011

Sofia, Bulgaria

Location

Santarus Clinical Investigational Site 2003

Winnipeg, Manitoba, R3A1R9, Canada

Location

Santarus Clinical Investigational Site 2008

Halifax, Nova Scotia, Canada

Location

Santarus Clinical Investigational Site 2004

London, Ontario, Canada

Location

Santarus Clinical Investigational Site 2010

Ottawa, Ontario, Canada

Location

Santarus Clinical Investigational Site 2002

Vaughan, Ontario, L4L4Y7, Canada

Location

Santarus Clinical Investigational Site 2009

Montreal, Quebec, Canada

Location

Santarus Clinical Investigational Site 2001

Sherbrooke, Quebec, J1G2E8, Canada

Location

Santarus Clinical Investigational Site 2007

Calgary, Canada

Location

Santarus Clinical Investigational Site 2005

London, Canada

Location

Santarus Clinical Investigational Site 2006

Québec, Canada

Location

Santarus Clinical Investigational Site 3001

Hradec Králové, Czechia

Location

Santarus Clinical Investigational Site 3006

Hradec Králové, Czechia

Location

Santarus Clinical Investigational Site 3005

Labem, Czechia

Location

Santarus Clinical Investigational Site 3003

Olomouc, Czechia

Location

Santarus Clinical Investigational Site 3004

Prague, Czechia

Location

Santarus Clinical Investigational Site 3007

Prague, Czechia

Location

Santarus Clinical Investigational Site 3009

Prague, Czechia

Location

Santarus Clinical Investigational Site 3002

Tábor, Czechia

Location

Santarus Clinical Investigational Site 3010

Ústí nad Orlicí, Czechia

Location

Santarus Clinical Investigational Site 3011

Valašské Meziříčí, Czechia

Location

Santarus Clinical Investigational Site 8001

Tallinn, Estonia

Location

Santarus Clinical Investigational Site 5010

Békéscsaba, Hungary

Location

Santarus Clinical Investigational Site 5008

Budapest, Hungary

Location

Santarus Clinical Investigational Site 5009

Budapest, Hungary

Location

Santarus Clinical Investigational Site 5001

Debrecen, Hungary

Location

Santarus Clinical Investigational Site 5003

Gyula, Hungary

Location

Santarus Clinical Investigational Site 5004

Kaposvár, Hungary

Location

Santarus Clinical Investigational Site 5002

Miskolc, Hungary

Location

Santarus Clinical Investigational Site 5006

Mosonmagyaróvár, Hungary

Location

Santarus Clinical Investigational Site 5011

Pécs, Hungary

Location

Santarus Clinical Investigational Site 5005

Szeged, Hungary

Location

Santarus Clinical Investigational Site 5007

Vác, Hungary

Location

Santarus Clinical Investigational Site 8101

Riga, Latvia

Location

Santarus Clinical Investigational Site 8102

Riga, Latvia

Location

Santarus Clinical Investigational Site 8103

Riga, Latvia

Location

Santarus Clinical Investigational Site 8202

Kaunas, Lithuania

Location

Santarus Clinical Investigational Site 8201

Vilnius, Lithuania

Location

Santarus Clinical Investigational Site 8203

Vilnius, Lithuania

Location

Santarus Clinical Investigational Site 6003

Elblag, Poland

Location

Santarus Clinical Investigational Site 6001

Krakow, Poland

Location

Santarus Clinical Investigational Site 6002

Sopot, Poland

Location

Santarus Clinical Investigational Site 6006

Szczecin, Poland

Location

Santarus Clinical Investigational Site 6004

Warsaw, Poland

Location

Santarus Clinical Investigational Site 6008

Warsaw, Poland

Location

Santarus Clinical Investigational Site 6005

Warszawy, Poland

Location

Santarus Clinical Investigational Site 9016

Lipetsk, Russia

Location

Santarus Clinical Investigational Site 9005

Moscow, Russia

Location

Santarus Clinical Investigational Site 9010

Moscow, Russia

Location

Santarus Clinical Investigational Site 9004

Nizhny Novgorod, Russia

Location

Santarus Clinical Investigational Site 9003

Ryazan, Russia

Location

Santarus Clinical Investigational Site 9001

Saint Petersburg, Russia

Location

Santarus Clinical Investigational Site 9008

Saint Petersburg, Russia

Location

Santarus Clinical Investigational Site 9013

Saint Petersburg, Russia

Location

Santarus Clinical Investigational Site 9014

Saint Petersburg, Russia

Location

Santarus Clinical Investigational Site 9009

Saratov, Russia

Location

Santarus Clinical Investigational Site 9007

Stavropol, Russia

Location

Santarus Clinical Investigational Site 9006

Ufa, Russia

Location

Santarus Clinical Investigational Site 9017

Volgograd, Russia

Location

Santarus Clinical Investigational Site 7010

Crimea, Ukraine

Location

Santarus Clinical Investigational Site 7002

Donetsk, Ukraine

Location

Santarus Clinical Investigational Site 7001

Kharkiv, Ukraine

Location

Santarus Clinical Investigational Site 7004

Kharkiv, Ukraine

Location

Santarus Clinical Investigational Site 7006

Kyiv, Ukraine

Location

Santarus Clinical Investigational Site 7008

Kyiv, Ukraine

Location

Santarus Clinical Investigational Site 7005

Vinnytsia, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 28333362 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

Lindsey.Mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Companies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: February 14, 2012
• Study Start: January 27, 2012
• Primary Completion: October 2, 2013
• Study Completion: October 2, 2013
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

ES (1); LI (3); LA (3); CZ (10); HU (11); US (39); PL (7); RU (13); CA (10); UA (7); BU (10)