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Ulcerative ColitisPhase 3NCT00679380

(CB-01-02/02) 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 71 sites in 15 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

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of… 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
514 participants
Where
71 sitesin 15 countries
Study dates
Jun 2008to Apr 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 anaemia, leucopaenia or granulocytopaenia.
Show all 21Show 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 tumour 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 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-humoural 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

71 sites in 15 countries.

71 sites in 15 countries

Poland13 sites

  • Gastromed S.C.

    Bialystok, Podlaskie Voivodeship, 15-842

  • Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa

    Bialystok, 15-842

  • NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw

    Gdynia, 81-572

  • NZOZ Centrum Leczenia Chorob Cywilizacyjnych

    Gdynia, 81-572

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,

    Krakow, 31-531

  • Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych

    Krakow, 31-531

  • Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

    Lodz, 90-302

  • NZOZ Polimedica

    Lodz, 90-302

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • Endoskopia Sp.z o.o.

    Sopot, 81-756

  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

    Warsaw, Masovian Voivodeship, 03-580

  • Centrum Leczenia Chorób Cywilizacyjnych

    Warsaw, Masovian Voivodeship

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Wejherowo, 84-200

Other trials in Poland

Russia11 sites

  • Federal State Institution ?National Medical Surgical Center

    Moscow, 105203

  • GU research educational medical centre of the administration of the affairs of the president of Russian Federation on the basis of State Healthcare Institution "State Clinical Hospital # 51"

    Moscow, 121309

  • State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care

    Moscow, 123423

  • GUZ of Moscow "City Clinical Hospital #24"

    Moscow, 127006

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Saint-Petersburg GUZ City polyclinic #38 28

    Saint Petersburg, 193015

  • Krestovsky Ireland Medical Institute

    Saint Petersburg, 197110

  • FGU North-West DIstrict Medical Center of Roszdrav

    Saint Petersburg, 199004

  • St. Petersburg State Medical Academy n.a. I.I. Mechnikov

    Saint Petersburg

  • ZAO Clinic Dvizhenie

    Volgograd, 400107

  • Yaroslavl Region Clinical Hospital

    Yaroslavl

Other trials in Russia

Ukraine6 sites

  • Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology

    Dnipro, 49074

  • City Clinical Emergency Hospital named after O.I.Meschaninov,

    Kharkiv, 61018

  • Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease

    Lviv, 79013

  • Odessa city Polyclinic #20, Therapeutic Dept. 6

    Odesa, 65114

  • Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital

    Uzhhorod

  • Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod"

    Uzhhorod

Other trials in Ukraine

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,

    Box Hill, VIC 3128

  • The Alfred Hospital

    Melbourne, 3004

  • Monash Medical Centre

    Melbourne, 3168

  • Centre for Digestive Diseases

    Sydney, New South Wales, 2046

Other trials in Australia

Sweden5 sites

  • Sahlgrenska Univerity Hospital

    Gothenburg, 416 85

  • Lund University Hospital

    Lund, 221 85

  • IBD-Unit, Sophiahemmet

    Stockholm, 11486

  • Div. of Gastroenterology and Hepatology

    Stockholm, 118 83

  • Dept. of Gastroenerology and Hepatology

    Stockholm, 171 76

Other trials in Sweden

Estonia4 sites

  • East Viru Central Hospital

    Kohtla-Järve, 30322

  • East Tallinn Central Hospital

    Tallinn, 10138

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Latvia4 sites

  • Daugavpils Regional Hospital

    Daugavpils, 5417

  • Paula Stradina Clinical University Hospital

    Riga, 1002

  • Digestive Disease Centre Gastro

    Riga, 1006

  • Clinical University Hospital Gailezers

    Riga, 1038

Other trials in Latvia

Lithuania4 sites

  • Kaunas Medical University Hospital

    Kaunas, 50009

  • Siauliai District Hospital

    Šiauliai, 76231

  • M.Marcinkeviciaus Hospital

    Vilnius, 03215

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 08661

Other trials in Lithuania

Romania4 sites

  • Spitalul Clinic Colentina Sectia Gastroenterologie

    Bucharest, 020125

  • Cabinet Medical

    Oradea

  • Spitalul Judetean Sibiu

    Sibiu

  • Centrul de Gastroenterologie Dr. Goldis Adrian

    Timișoara

Other trials in Romania

Slovakia4 sites

  • FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova

    Bratislava, 813 69

  • FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska

    Bratislava, 826 06

  • Gastroenterologické a Hepatologické centrum

    Nitra, 94901

  • NsP Nove Mesto nad Vahom n.o.

    Nové Mesto nad Váhom

Other trials in Slovakia

United Kingdom4 sites

  • University Hospital of Coventry and Warwickshire

    Coventry, CV2 2DX

  • Gastrointestinal Unit

    Edinburgh, EH4 2XU

  • St Marks Hospital

    Harrow, HA1 3UJ

  • John Radcliffe Hospital

    Headington, Oxford, OX3 9DU

Other trials in United Kingdom

Italy3 sites

  • CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica

    Aviano, 33081

  • Dipartimento di Medicina Interna e Specialità Mediche (DIMI)

    Genova, 16132

  • Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia

    Milan, 20098

Other trials in Italy

France2 sites

  • Hôpital Beaujon

    Clichy

  • Hospital Saint-Louis

    Paris

Other trials in France

Belgium1 site

  • Imelda Hospital

    Bonheiden

Other trials in Belgium

Israel1 site

  • Yaron Niv

    Petah Tikva

Other trials in Israel

About this study

Official title: Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

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 three placebo Entocort enteric-coated (EC®) overencapsulated capsules, or
  2. One budesonide MMX® 9 mg tablet plus three placebo Entocort EC® overencapsulated capsules, or
  3. Three placebo Entocort EC® overencapsulated capsules plus one placebo budesonide MMX® tablet, or
  4. Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet, daily for eight weeks.

Hence, each patient is to take four tablets/capsules per day of active or placebo study medication as per the randomization schedule. Placebo tablets of Budesonide MMX® and placebo overencapsulated capsules of Entocort EC® 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, Entocort EC® 3 mg, Placebo
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

  • Entocort EC® 3 mgDrug

    9 mg/day, 3 mg tablets

  • PlaceboDrug

    Placebo

Study groups in NCT00679380
Study groupRoleWhat they receive
1: budesonide-MMX® 6 mgExperimentalOne budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
Receives: Procedure: Blood sampling, endoscopy; Drug: Budesonide MMX® 6 mg
2: budesonide-MMX® 9 mgExperimentalOne budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
Receives: Procedure: Blood sampling, endoscopy; Drug: Budesonide MMX® 9 mg
3: Entocort EC® 3 mgActive comparatorThree Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
Receives: Procedure: Blood sampling, endoscopy; Drug: Entocort EC® 3 mg
4: PlaceboPlacebo comparatorThree placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
Receives: Procedure: Blood sampling, endoscopy; Drug: Placebo

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 an 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 completionFeb 2010
  4. Study completionApr 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
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00679380
Sponsor's protocol ID
CB-01-02/02
Status last verified
Nov 2019
First submitted
14 May 2008
Last updated
10 Dec 2019
Data monitoring committee
No

Publications

  • Travis SP, Danese S, Kupcinskas L, Alexeeva O, D'Haens G, Gibson PR, Moro L, Jones R, Ballard ED, Masure J, Rossini M, Sandborn WJ. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut. 2014 Mar;63(3):433-41. doi: 10.1136/gutjnl-2012-304258. Epub 2013 Feb 22.

    PubMed 23436336

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 71 sites in 15 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 21 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 71 sites in Poland, Russia, Ukraine, Australia, Sweden and 10 more countries. 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 NCT00679380, 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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