NCT00450086

Brief Summary

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

4.3 years

First QC Date

March 20, 2007

Last Update Submit

May 16, 2014

Conditions

Collagenous Colitis

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical remission (<= 3 stools per day) after 8 weeks

    8 weeks

Secondary Outcomes (9)

  • Rate of clinical remission (<= 3 stools per day) after 2 weeks

    2 weeks

  • Time to remission

  • Impact on stool consistency (watery/soft/solid)

    8 weeks

  • Impact on abdominal pain

    8 weeks

  • Impact on patient's general well-being

    8 weeks

  • +4 more secondary outcomes

Study Arms (3)

A

EXPERIMENTAL
Drug: Budesonide

B

EXPERIMENTAL
Drug: Mesalazine

C

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BudesonideDRUG

9 mg per day

A
MesalazineDRUG

3 g per day

B
PlaceboDRUG

0 g per day

C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 4 watery/soft stools on at least 4 days in the week prior to baseline
  • \> 3 stools per day on average within the last 7 days prior to baseline
  • Symptoms (chronic watery diarrhea) for at least 3 months before baseline
  • Complete colonoscopy within the last 12 weeks before baseline
  • Histologically confirmed diagnosis of collagenous colitis

You may not qualify if:

  • Evidence of infectious diarrhea
  • Celiac disease
  • Endoscopic-histologic findings, which may have caused diarrhea
  • History of partial colonic resection
  • Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
  • Active colorectal cancer or a history of colorectal cancer
  • Severe co-morbidity substantially reducing life expectancy
  • Abnormal hepatic function or liver cirrhosis (ALT, AST or AP \>= 2 x ULN)
  • Abnormal renal function (Cystatin C \> ULN)
  • Active peptic ulcer disease, local intestinal infection
  • Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
  • Hemorrhagic diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of digestive diseases

Hamburg, 20249, Germany

Location

Related Publications (1)

  • Miehlke S, Madisch A, Kupcinskas L, Petrauskas D, Bohm G, Marks HJ, Neumeyer M, Nathan T, Fernandez-Banares F, Greinwald R, Mohrbacher R, Vieth M, Bonderup OK; BUC-60/COC Study Group. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. Gastroenterology. 2014 May;146(5):1222-30.e1-2. doi: 10.1053/j.gastro.2014.01.019. Epub 2014 Jan 15.

    PMID: 24440672RESULT

MeSH Terms

Conditions

Colitis, Collagenous

Interventions

BudesonideMesalamine

Condition Hierarchy (Ancestors)

Colitis, MicroscopicColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compoundsmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Stephan Miehlke, Professor

    Center for digestive diseases

    PRINCIPAL INVESTIGATOR

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

March 20, 2007

First Posted

March 21, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

DE(1)