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Ulcerative ColitisPhase 3NCT00679432

(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

A Phase 3 study testing Blood sampling, endoscopy, budesonide-MMX® 6 mg and budesonide-MMX® 9 mg in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 105 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Blood sampling, endoscopy, budesonide-MMX® 6 mg and budesonide-MMX® 9 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
510 participants
Where
105 sitesin 4 countries
Study dates
Jun 2008to Jun 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients fulfilling the following criteria at the screening visit are eligible for participation in the study:
  • Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months.
  • Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to Sutherland.
  • All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate <1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study period.
  • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects.
  • Ability to co-operate with the investigator and to comply with the requirements of the entire study.
  • Must be able to understand and voluntarily sign written informed consent prior to inclusion in the study.

Who cannot join

  • Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
  • Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line).
  • Patients with severe ulcerative colitis (UCDAI >10).
  • Patients with infectious colitis.
  • Evidence or history of toxic megacolon.
  • Severe anemia, leucopenia or granulocytopenia.
Show all 22Show fewer
  • Use of oral or rectal steroids in the last 4 weeks.
  • Use of immuno-suppressive agents in the last 8 weeks before the study.
  • Use of anti tumor necrosis factor alpha (anti-TNFα) agents in the last 3 months.
  • Concomitant use of any rectal preparation.
  • Concomitant use of antibiotics.
  • Concurrent use of cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors.
  • Patients with intolerance to salicylates.
  • Patients with verified, presumed or expected pregnancy or ongoing lactation.
  • Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters (i.e. 2 x upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma glutamyl transpeptidase [GGT] or creatinine).
  • Patient with severe diseases in other organs and systems.
  • Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents.
  • Patients diagnosed with type 1 diabetes.
  • Patients diagnosed with, or with a family history of, glaucoma.
  • All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy.
  • Participation in experimental therapeutic studies in the last 3 months. (Note: patients who participated in observational only studies 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 subject or obscure the interpretation of adverse events (AEs).

Trial locations and contacts

105 sites in 4 countries.

105 sites in 4 countries

United States76 sites

  • Santarus Clinical Investigational Site 5085

    Addison, Illinois, 60101

  • Santarus Clinical Investigational Site 5044

    Anaheim, California, 92801

  • Santarus Clinical Investigational Site 5090

    Annapolis, Maryland, 21401

  • Santarus Clinical Investigational Site 5016

    Atlanta, Georgia, 30312

  • Santarus Clinical Investigational Site 5021

    Austin, Texas, 78745

  • Santarus Clinical Investigational Site 5025

    Baltimore, Maryland, 21229

  • Santarus Clinical Investigational Site 5086

    Bloomington, Indiana, 47403

  • Santarus Clinical Investigational Site 5046

    Boston, Massachusetts, 02114

  • Santarus Clinical Investigational Site 5089

    Boynton Beach, Florida, 33426

  • Santarus Clinical Investigational Site 5115

    Brockton, Massachusetts, 02301

  • Santarus Clinical Investigational Site 5118

    Canton, Ohio, 44701

  • Santarus Clinical Investigational Site 5010

    Chesterfield, Michigan, 48047

  • Santarus Clinical Investigational Site 5097

    Christiansburg, Virginia, 24073

  • Santarus Clinical Investigational Site 5045

    Cincinnati, Ohio, 45218

  • Santarus Clinical Investigational Site 5053

    Clive, Iowa, 50325

  • Santarus Clinical Investigational Site 5056

    Columbus, Georgia, 31904

  • Santarus Clinical Investigational Site 5078

    Dayton, Ohio, 45440

  • Santarus Clinical Investigational Site 5066

    Duncansville, Pennsylvania, 16635

  • Santarus Clinical Investigational Site 5094

    Egg Harbor, New Jersey, 08234

  • Santarus Clinical Investigational Site 5099

    Encinitas, California, 92024

  • Santarus Clinical Investigational Site 5068

    Evanston, Illinois, 60201

  • Santarus Clinical Investigational Site 5096

    Fayetteville, North Carolina, 28304

  • Santarus Clinical Investigational Site 5075

    Fremont, California, 94536

  • Santarus Clinical Investigational Site 5011

    Great Neck, New York, 11021

  • Santarus Clinical Investigational Site 5041

    Hollywood, Florida, 33021

  • Santarus Clinical Investigational Site 5092

    Hollywood, Maryland, 20636

  • Santarus Clinical Investigational Site 5076

    Houston, Texas, 77034

  • Santarus Clinical Investigational Site 5108

    Houston, Texas, 77079

  • Santarus Clinical Investigational Site 5019

    Houston, Texas, 77090

  • Santarus Clinical Investigational Site 5036

    Houston, Texas, 77090

  • Santarus Clinical Investigational Site 5058

    Huntersville, North Carolina, 28078

  • Santarus Clinical Investigational Site 5051

    Huntsville, Alabama, 35801

  • Santarus Clinical Investigational Site 5063

    Irving, Texas, 75061

  • Santarus Clinical Investigational Site 5130

    Jackson, Tennessee, 38305

  • Santarus Clinical Investigational Site 5095

    Kingsport, Tennessee, 37660

  • Santarus Clinical Investigational Site 5072

    Kingwood, Texas, 77339

  • Santarus Clinical Investigational Site 5054

    La Porte, Texas, 77571

  • Santarus Clinical Investigational Site 5087

    Lakewood, California, 90712

  • Santarus Clinical Investigational Site 5030

    Lewisville, Texas, 75057

  • Santarus Clinical Investigational Site 5033

    Los Angeles, California, 90045

  • Santarus Clinical Investigational Site 5005

    Marlton, New Jersey, 08053

  • Santarus Clinical Investigational Site 5120

    Mentor, Ohio, 44060

  • Santarus Clinical Investigational Site 5008

    Metairie, Louisiana, 70006

  • Santarus Clinical Investigational Site 5102

    Mobile, Alabama, 36606

  • Santarus Clinical Investigational Site 5091

    New Bern, North Carolina, 28562

  • Santarus Clinical Investigational Site 5055

    New Smyrna Beach, Florida, 32168

  • Santarus Clinical Investigational Site 5101

    New York, New York, 10016

  • Santarus Clinical Investigational Site 5119

    Norfolk, Virginia, 23502

  • Santarus Clinical Investigational Site 5070

    Palm Springs, California, 92262

  • Santarus Clinical Investigational Site 5020

    Pittsford, New York, 14534

  • Santarus Clinical Investigational Site 5093

    Plano, Texas, 75075

  • Santarus Clinical Investigational Site 5074

    Port Orange, Florida, 32127

  • Santarus Clinical Investigational Site 5065

    Pottstown, Pennsylvania, 19464

  • Santarus Clinical Investigational Site 5077

    Prince Frederick, Maryland, 20678

  • Santarus Clinical Investigational Site 5015

    Salt Lake City, Utah, 84107

  • Santarus Clinical Investigational Site 5049

    San Antonio, Texas, 78229

  • Santarus Clinical Investigational Site 5100

    San Antonio, Texas, 78229

  • Santarus Clinical Investigational Site 5079

    San Antonio, Texas, 78258

  • Santarus Clinical Investigational Site 5067

    San Diego, California, 92101

  • Santarus Clinical Investigational Site 5028

    San Francisco, California, 94117

  • Santarus Clinical Investigational Site 5103

    Savannah, Georgia, 31406

  • Santarus Clinical Investigational Site 5035

    Sayre, Pennsylvania, 18840

  • Santarus Clinical Investigational Site 5107

    Sioux Falls, South Dakota, 57105

  • Santarus Clinical Investigational Site 5105

    St Louis, Missouri, 63128

  • Santarus Clinical Investigational Site 5014

    Sylacauga, Alabama, 35150

  • Santarus Clinical Investigational Site 5032

    Tampa, Florida, 33607

  • Santarus Clinical Investigational Site 5009

    Tampa, Florida, 33613

  • Santarus Clinical Investigational Site 5098

    Tomball, Texas, 77375

  • Santarus Clinical Investigational Site 5006

    Troy, Michigan, 48098

  • Santarus Clinical Investigational Site 5088

    Tucson, Arizona, 85712

  • Santarus Clinical Investigational Site 5024

    Vineland, New Jersey, 08360

  • Santarus Clinical Investigational Site 5110

    West Palm Beach, Florida, 33409

  • Santarus Clinical Investigational Site 5124

    Wilmington, North Carolina, 28403

  • Santarus Clinical Investigational Site 5047

    Winter Park, Florida, 32789

  • Santarus Clinical Investigational Site 5004

    Wyoming, Michigan, 49519

  • Santarus Clinical Investigational Site 5003

    Zephyrhills, Florida, 33542

Other trials in United States

India18 sites

  • Santarus Clinical Investigational Site 9001

    Andhra Pradesh

  • Santarus Clinical Investigational Site 9009

    Andhra Pradesh

  • Santarus Clinical Investigational Site 9012

    Andhra Pradesh

  • Santarus Clinical Investigational Site 9016

    Andhra Pradesh

  • Santarus Clinical Investigational Site 9006

    Assam

  • Santarus Clinical Investigational Site 9007

    Gujarat

  • Santarus Clinical Investigational Site 9004

    Karnataka

  • Santarus Clinical Investigational Site 9015

    Karnataka

  • Santarus Clinical Investigational Site 9003

    Kerala

  • Santarus Clinical Investigational Site 9002

    Maharashtra

  • Santarus Clinical Investigational Site 9008

    Maharashtra

  • Santarus Clinical Investigational Site 9010

    Maharashtra

  • Santarus Clinical Investigational Site 9011

    Maharashtra

  • Santarus Clinical Investigational Site 9013

    Maharashtra

  • Santarus Clinical Investigational Site 9017

    Maharashtra

  • Santarus Clinical Investigational Site 9018

    Rajasthan

  • Santarus Clinical Investigational Site 9005

    Tamil Nadu

  • Santarus Clinical Investigational Site 9014

    Uttar Pradesh

Other trials in India

Canada10 sites

  • Santarus Clinical Investigational Site 6005

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • Santarus Clinical Investigational Site 6001

    Montreal, Quebec, H1T 2M4

  • Santarus Clinical Investigational Site 6002

    Québec, Quebec, G1R 2J6

  • Santarus Clinical Investigational Site 6004

    Richmond Hill, Ontario, L4B 3P8

  • Santarus Clinical Investigational Site 6016

    Saskatoon, Saskatchewan, S7N 0W8

  • Santarus Clinical Investigational Site 6017

    Toronto, Ontario, M4N 3N5

  • Santarus Clinical Investigational Site 6006

    Toronto, M3N 2V7

  • Santarus Clinical Investigational Site 6000

    Vancouver, British Columbia, V5Z 1H2

  • Santarus Clinical Investigational Site 6014

    Vancouver, British Columbia, V6Z 2K5

  • Santarus Clinical Investigational Site 6008

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

Mexico1 site

  • Santarus Clinical Investigational Site 7000

    Central, La Paz Baja California Sur, 23000

Other trials in Mexico

About this study

Official title: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.

The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.

Read the detailed description

Each patient will receive one of the following regimens in the morning after breakfast:

  1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or
  2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or
  3. two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or
  4. two Asacol® 400 mg over encapsulated tablets plus one placebo budesonide tablet, daily for 8 weeks.

Each patient will also receive on each day after the midday meal and after the evening meal either:

  • two Asacol® 400 mg over-encapsulated tablets (Group 4), or
  • the equivalent placebo Asacol® over-encapsulated tablets, (Groups 1, 2 and 3)

Hence, each patient is to take seven tablets per day of active or placebo study medication as per the randomization schedule. Placebo tablets of budesonide-MMX™ and placebo over-encapsulated tablets of Asacol® will be used to maintain the study blind using a double-dummy technique.

During the study, five visits to the clinical center are scheduled: one at Screening and three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety follow up visit will take place about 2 weeks after the final study visit. If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be conducted.

Being tested
Blood sampling, endoscopy, budesonide-MMX® 6 mg, budesonide-MMX® 9 mg, Placebo, Asacol® 400 mg
Keywords
Ulcerative colitis
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampling, endoscopyProcedure or surgery

    Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores

  • budesonide-MMX® 6 mgDrug

    6 mg/day, 6 mg tablets

  • budesonide-MMX® 9 mgDrug

    9 mg/day, 9 mg tablets

  • PlaceboDrug

    Placebo

  • Asacol® 400 mgDrug

    2400 mg/day, 400 mg tablets

Study groups in NCT00679432
Study groupRoleWhat they receive
1: budesonide-MMX® 6 mgExperimentalOne budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Receives: Procedure: Blood sampling, endoscopy; Drug: budesonide-MMX® 6 mg
2: budesonide-MMX® 9 mgExperimentalOne budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Receives: Procedure: Blood sampling, endoscopy; Drug: budesonide-MMX® 9 mg
3: PlaceboPlacebo comparatorTwo placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Receives: Procedure: Blood sampling, endoscopy; Drug: Placebo
4: Asacol® 400 mgActive comparatorTwo Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Receives: Procedure: Blood sampling, endoscopy; Drug: Asacol® 400 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical and Endoscopic Remission.

    Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.

    Measured: 8 weeks

Secondary outcomes (2)

  1. Clinical Improvement.

    Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.

    Measured: 8 weeks

  2. Endoscopic Improvement

    Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.

    As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionMay 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00679432
Sponsor's protocol ID
CB-01-02/01
Status last verified
Nov 2019
First submitted
14 May 2008
Last updated
10 Dec 2019
Data monitoring committee
No

Publications

  • Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, Huang M, Yeung P, Ballard ED 2nd. Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012 Nov;143(5):1218-1226.e2. doi: 10.1053/j.gastro.2012.08.003. Epub 2012 Aug 11.

    PubMed 22892337

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Blood sampling, endoscopy, budesonide-MMX® 6 mg and budesonide-MMX® 9 mg in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 105 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, India, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical and Endoscopic Remission. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00679432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.

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