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CompletedNCT00679380Updated Dec 10, 2019Results posted

(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 interventional study of Blood sampling, endoscopy and Budesonide MMX® 6 mg in Ulcerative Colitis, sponsored by Bausch Health Americas, Inc.. Completed at 71 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-10.

Sponsored by Bausch Health Americas, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
514
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ulcerative Colitis

Keywords

  • Ulcerative colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 514 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
    • 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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
514 participants (actual)

Study arms

  • Experimental
    1: budesonide-MMX® 6 mg

    One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.

    Procedure: Blood sampling, endoscopy · Drug: Budesonide MMX® 6 mg

  • Experimental
    2: budesonide-MMX® 9 mg

    One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.

    Procedure: Blood sampling, endoscopy · Drug: Budesonide MMX® 9 mg

  • Active comparator
    3: Entocort EC® 3 mg

    Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.

    Procedure: Blood sampling, endoscopy · Drug: Entocort EC® 3 mg

  • Placebo comparator
    4: Placebo

    Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.

    Procedure: Blood sampling, endoscopy · Drug: Placebo

Interventions

  • ProcedureBlood sampling, endoscopy

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

  • DrugBudesonide MMX® 6 mg

    6 mg/day, 6 mg tablets

  • DrugBudesonide MMX® 9 mg

    9 mg/day, 9 mg tablets

  • DrugEntocort EC® 3 mg

    9 mg/day, 3 mg tablets

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  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.

    Time frame: 8 weeks

Secondary outcomes

  1. Clinical Improvement.

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

    Time frame: 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.

    Time frame: 8 weeks

07

Results

Posted Aug 1, 2014

Participant flow

Recruited from July 2008 to February 2010.

Participant flow — Overall Study
Milestone1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: Placebo
Started10910910389
Completed67766861
Not completed42333528

Outcome measures

PrimaryClinical 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.

Time frame:
8 weeks
Reported as:
Number · percentage of patients
Clinical and Endoscopic Remission.
percentage of patients1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: Placebo
Clinical and Endoscopic Remission.8.3 (3.1 to 13.4)17.4 (10.3 to 24.6)12.6 (6.2 to 19.0)4.5 (0.2 to 8.8)
Statistical analysis
  • 1: Budesonide-MMX® 6 mg vs 4: Placebo · Chi-squared · p = 0.2876 · Difference in proportions: 3.8 · 95% CI -3.0 to 10.5The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).
  • 2: Budesonide-MMX® 9 mg vs 4: Placebo · Chi-squared · p = 0.0047 · Difference in proportions: 12.9 · 95% CI 4.6 to 21.3See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
  • 3: Entocort EC® 3 mg vs 4: Placebo · Chi-squared · p = 0.0481 · Difference in proportions: 8.1 · 95% CI 0.4 to 15.9See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
SecondaryClinical Improvement.

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

Time frame:
8 weeks
Reported as:
Number · percentage of patients
Clinical Improvement.
percentage of patients1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: Placebo
Clinical Improvement.25.7 (17.5 to 33.9)42.2 (32.9 to 51.5)33.0 (23.9 to 42.1)33.7 (23.9 to 43.5)
Statistical analysis
  • 1: Budesonide-MMX® 6 mg vs 4: Placebo · Chi-squared · p = 0.2174 · Difference in proportions: -8.0 · 95% CI -20.8 to 4.The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).
  • 2: Budesonide-MMX® 9 mg vs 4: Placebo · Chi-squared · p = 0.2215 · Difference in proportions: 8.5 · 95% CI -5.0 to 22.0See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
  • 3: Entocort EC® 3 mg vs 4: Placebo · Chi-squared · p = 0.9185 · Difference in proportions: -0.7 · 95% CI -14.1 to 12.7See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
SecondaryEndoscopic 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.

Time frame:
8 weeks
Reported as:
Number · percentage of patients
Endoscopic Improvement.
percentage of patients1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: Placebo
Endoscopic Improvement.25.7 (17.5 to 33.9)42.2 (32.9 to 51.5)36.9 (27.6 to 46.2)31.5 (21.8 to 41.1)
Statistical analysis
  • 3: Entocort EC® 3 mg vs 4: Placebo · Chi-squared · p = 0.4293 · Difference in proportions: 5.4 · 95% CI -8.0 to 18.8The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).

Adverse events

Collected over 56 day ± 2 day (study duration) + 30 day safety followup period.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1: Budesonide-MMX® 6 mg—3/128 (2.3%)77/128 (60.2%)
2: Budesonide-MMX® 9 mg—4/128 (3.1%)67/128 (52.3%)
3: Entocort EC® 3 mg—1/126 (0.8%)68/126 (54%)
4: Placebo—5/129 (3.9%)52/129 (40.3%)
Most frequent serious events
Most frequent serious events
Event1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: Placebo
Colitis ulcerativeGastrointestinal disorders1/1281/1281/1263/129
Treatment failureGeneral disorders2/1280/1280/1260/129
Gastric ulcerGastrointestinal disorders0/1280/1281/1260/129
EnterocolitisGastrointestinal disorders0/1281/1280/1260/129
NauseaGastrointestinal disorders0/1281/1280/1260/129
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1280/1280/1260/129
Urge incontinenceRenal and urinary disorders0/1281/1280/1260/129
Signet-ring cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1280/1280/1261/129
Personality disorderPsychiatric disorders0/1280/1280/1261/129
Most frequent other events
Showing 10 of 22
Most frequent other events
Event1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: Placebo
Colitis ulcerativeGastrointestinal disorders20/12826/12815/12614/129
HeadacheNervous system disorders21/12820/1289/1268/129
NauseaGastrointestinal disorders8/1286/1283/1263/129
NasopharyngitisInfections and infestations1/1288/1286/1262/129
Abdominal painGastrointestinal disorders3/1285/1287/1267/129
FlatulenceGastrointestinal disorders5/1287/1287/1263/129
Blood cortisol decreasedInvestigations7/1283/1284/1261/129
AnaemiaBlood and lymphatic system disorders5/1283/1280/1261/129
Abdominal pain upperGastrointestinal disorders5/1283/1282/1263/129
CushingoidEndocrine disorders2/1281/1282/1265/129

Baseline characteristics

Baseline characteristics were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.

Age, Categorical
Age, Categorical(Participants)1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: PlaceboTotal
<=18 years00000
Between 18 and 65 years1021079782388
>=65 years726722
Age, Continuous
Age, Continuous(years)1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: PlaceboTotal
Mean43.6 ± 13.642.8 ± 13.943.4 ± 14.044.8 ± 13.043.6 ± 13.6
Sex: Female, Male
Sex: Female, Male(Participants)1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: PlaceboTotal
Female52454832177
Male57645557233
Region of Enrollment
Region of Enrollment(participants)1: Budesonide-MMX® 6 mg2: Budesonide-MMX® 9 mg3: Entocort EC® 3 mg4: PlaceboTotal
Estonia1166528
Slovakia1055727
Ukraine767525
Lithuania1917111259
Russian Federation24353428121
United Kingdom24309
Italy1812181361
France01113
Poland71413943
Belgium20002
Romania251311
Australia11327
Latvia22026
Sweden31026
Israel10102
08

Study locations

71 sites
  • Centre for Digestive Diseases
    Sydney, New South Wales 2046, Australia
  • Royal Adelaide Hospital
    Adelaide, 5000, Australia
  • Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,
    Box Hill, VIC 3128, Australia
  • The Alfred Hospital
    Melbourne, 3004, Australia
  • Monash Medical Centre
    Melbourne, 3168, Australia
  • Imelda Hospital
    Bonheiden, Belgium
  • East Viru Central Hospital
    Kohtla-Jarve, 30322, Estonia
  • East Tallinn Central Hospital
    Tallinn, 10138, Estonia
  • West Tallinn Central Hospital
    Tallinn, 10617, Estonia
  • Tartu University Hospital
    Tartu, 51014, Estonia
  • Hôpital Beaujon
    Clichy Cedex, France
  • Hospital Saint-Louis
    Paris, France
  • Yaron Niv
    Petach Tikva, Israel
  • CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica
    Aviano, 33081, Italy
  • Dipartimento di Medicina Interna e Specialità Mediche (DIMI)
    Genova, 16132, Italy
  • Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia
    Milan, 20098, Italy
  • Daugavpils Regional Hospital
    Daugavpils, 5417, Latvia
  • Paula Stradina Clinical University Hospital
    Riga, 1002, Latvia
  • Digestive Disease Centre Gastro
    Riga, 1006, Latvia
  • Clinical University Hospital Gailezers
    Riga, 1038, Latvia
  • Kaunas Medical University Hospital
    Kaunas, 50009, Lithuania
  • Siauliai District Hospital
    Siauliai, 76231, Lithuania
  • M.Marcinkeviciaus Hospital
    Vilnius, 03215, Lithuania
  • Vilnius University Hospital Santariskiu Klinikos
    Vilnius, 08661, Lithuania
  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
    Warszawa, Mazowieckie 03-580, Poland
  • Centrum Leczenia Chorób Cywilizacyjnych
    Warszawa, Mazowieckie, Poland
  • Gastromed S.C.
    Białystok, Podlaskie 15-842, Poland
  • Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa
    Bialystok, 15-842, Poland
  • NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw
    Gdynia, 81-572, Poland
  • NZOZ Centrum Leczenia Chorob Cywilizacyjnych
    Gdynia, 81-572, Poland
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,
    Krakow, 31-531, Poland
  • Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych
    Kraków, 31-531, Poland
  • Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
    Lodz, 90-302, Poland
  • Endoskopia Sp. z o.o.
    Sopot, 81-756, Poland
  • Endoskopia Sp.z o.o.
    Sopot, 81-756, Poland
  • Indywidualna Specjalistyczna Praktyka Lekarska
    Wejherowo, 84-200, Poland
  • NZOZ Polimedica
    Łódź, 90-302, Poland
  • Spitalul Clinic Colentina Sectia Gastroenterologie
    Bucuresti, 020125, Romania
  • Cabinet Medical
    Oradea, Romania
  • Spitalul Judetean Sibiu
    Sibiu, Romania
  • Centrul de Gastroenterologie Dr. Goldis Adrian
    Timisoara, Romania
  • Federal State Institution ?National Medical Surgical Center
    Moscow, 105203, Russian Federation
  • 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, Russian Federation
  • State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care
    Moscow, 123423, Russian Federation
  • GUZ of Moscow "City Clinical Hospital #24"
    Moscow, 127006, Russian Federation
  • Rostov State Medical University
    Rostov-on-Don, 344022, Russian Federation
  • Saint-Petersburg GUZ City polyclinic #38 28
    St Petersburg, 193015, Russian Federation
  • St. Petersburg State Medical Academy n.a. I.I. Mechnikov
    St Petersburg, Russian Federation
  • Krestovsky Ireland Medical Institute
    St-Petersburg, 197110, Russian Federation
  • FGU North-West DIstrict Medical Center of Roszdrav
    St-Petersburg, 199004, Russian Federation
  • ZAO Clinic Dvizhenie
    Volgograd, 400107, Russian Federation
  • Yaroslavl Region Clinical Hospital
    Yaroslavl, Russian Federation
  • FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova
    Bratislava, 813 69, Slovakia
  • FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska
    Bratislava, 826 06, Slovakia
  • Gastroenterologické a Hepatologické centrum
    Nitra, 94901, Slovakia
  • NsP Nove Mesto nad Vahom n.o.
    Nové Mesto nad Váhom, Slovakia
  • Sahlgrenska Univerity Hospital
    Göteborg, 416 85, Sweden
  • Lund University Hospital
    Lund, 221 85, Sweden
  • IBD-Unit, Sophiahemmet
    Stockholm, 11486, Sweden
  • Div. of Gastroenterology and Hepatology
    Stockholm, 118 83, Sweden
  • Dept. of Gastroenerology and Hepatology
    Stockholm, 171 76, Sweden
  • Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology
    Dnepropetrovsk, 49074, Ukraine
  • City Clinical Emergency Hospital named after O.I.Meschaninov,
    Kharkov, 61018, Ukraine
  • Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease
    Lviv, 79013, Ukraine
  • Odessa city Polyclinic #20, Therapeutic Dept. 6
    Odessa, 65114, Ukraine
  • Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital
    Uzhorod, Ukraine
  • Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod"
    Uzhorod, Ukraine
  • John Radcliffe Hospital
    Headington, Oxford OX3 9DU, United Kingdom
  • University Hospital of Coventry and Warwickshire
    Coventry, CV2 2DX, United Kingdom
  • Gastrointestinal Unit
    Edinburgh, EH4 2XU, United Kingdom
  • St Marks Hospital
    Harrow, HA1 3UJ, United Kingdom
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00679380
Lead sponsor
Bausch Health Americas, Inc.
Collaborators
Cosmo Technologies Ltd
Responsible party
Sponsor
First posted
May 16, 2008
Start date
Jun 2008
Primary completion
Feb 2010
Completion
Apr 2010
Results posted
Aug 1, 2014
Last update
Dec 10, 2019

Study contacts

Simon Travis
principal investigator · Oxford University Hospitals NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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