NCT00952952

Brief Summary

Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects that show improvement will be followed for 4 weeks post medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

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

February 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
Last Updated

May 24, 2011

Status Verified

May 1, 2011

Enrollment Period

9 months

First QC Date

August 4, 2009

Last Update Submit

May 20, 2011

Conditions

Microscopic ColitisDiarrhea

Outcome Measures

Primary Outcomes (1)

  • To determine the efficacy of mesalamine at 1.2g and 4.8g doses in microscopic colitis for providing relief of diarrhea

Secondary Outcomes (1)

  • To compare the safety and tolerability of mesalamine at 1.2g and 4.8g doses in patients with microscopic colitis.

Interventions

MesalamineDRUG

Eligibility Criteria

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

You may qualify if:

  • Subjects must be 18 years old and older.
  • Have diarrhea and microscopic colitis.
  • They need to have a colon biopsy done at the Mayo Clinic in Rochester, MN within a year of enrollment.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Colitis, MicroscopicDiarrhea

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

February 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 24, 2011

Record last verified: 2011-05

Locations

US(1)