NCT00194818

Brief Summary

We, the investigators at University of Washington, plan on evaluating the effect of open label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per day) on its ability to induce remission in patients with mild to moderately active ulcerative colitis. We hypothesize that both regimens will have the same efficacy and no difference in side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_4

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

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

Enrollment Period

4.2 years

First QC Date

September 15, 2005

Last Update Submit

February 13, 2008

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in each arm that have presence of clinical remission by week 12, as defined by UCAI score of less than or equal to 4.

    12 weeks

Secondary Outcomes (6)

  • Proportion of patients in each arm who respond to therapy as measured by a reduction in UCAI score of greater than or equal to 4.

    12 weeks

  • Proportion of patients in each arm who have improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) scores

    12 weeks

  • Time to clinical response

    12 weeks

  • Self reported patient satisfaction

    12 weeks

  • Patient compliance based on pill count

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Asacol 6 tablets BID (4.8 grams/day)

Drug: Asacol (mesalamine)

2

ACTIVE COMPARATOR

Asacol 4 tablets TID (4.8 grams/day)

Drug: Asacol (mesalamine)

Interventions

Asacol (mesalamine)DRUG

Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks.

Also known as: Mesalamine
12

Eligibility Criteria

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

You may qualify if:

  • Ability to provide consent
  • Age older than 18 years and younger than 80 years
  • Confirmed diagnosis of ulcerative colitis by endoscopic or radiologic evaluation at least 4 weeks prior to randomization
  • Active ulcerative colitis at time of screening (UCAI \> 4 \<12)
  • Receiving stable doses of medications at least 4 weeks prior to receiving the first dose of study drug
  • Agree to use of an adequate form of contraception throughout the study period for sexually active males and females of child-bearing potential
  • Able to comply with protocol requirements
  • Subjects may not be on any form of corticosteroids, immunosuppressives or anti-tumor necrosis factor (TNF) therapy

You may not qualify if:

  • Critically ill
  • Risk factors for toxicity to Asacol, including pre-existing hepatic disease (biopsy-proven cirrhosis, chronic active hepatitis, or serum aspartate aminotransferase, bilirubin, or alkaline phosphatase concentrations at least twice the upper limit of normal except for patients with the diagnosis of primary sclerosing cholangitis, a liver disease which occurs in patients with ulcerative colitis), renal dysfunction (serum creatinine concentration greater than 1.7 mg per deciliter \[150mmol per liter\]). Patients with primary sclerosing cholangitis (PSC), a liver disease that is often associated with ulcerative colitis, will be allowed to participate in the study if their liver function tests have been stable for at least 4 weeks. Previous studies have not shown any detrimental effects of Asacol on PSC.
  • Systemic infections
  • Pregnancy or a desire to become pregnant
  • High alcohol consumption (more than seven drinks per week)
  • Known hypersensitivity to Asacol
  • Estimated survival of less than one year
  • Unwilling to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Scott D Lee, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 19, 2005

Study Start

June 1, 2003

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

US(1)