NCT01257386

Brief Summary

To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients with active ulcerative colitis (UC) treated for 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2010

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

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

December 8, 2010

Last Update Submit

April 3, 2013

Conditions

Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Reduction degree of UC-DAI

    Week 8

Secondary Outcomes (1)

  • 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate

    Week 8

Study Arms (2)

Asacol®

EXPERIMENTAL

Import Mesalazine

Drug: Asacol®

Mesalazine

ACTIVE COMPARATOR

Marketed Mesalazine

Drug: Mesalazine

Interventions

Asacol®DRUG

400mg tablets

Also known as: Import Mesalazine
Asacol®
MesalazineDRUG

400mg tablets

Also known as: Marketed Mesalazine
Mesalazine

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with Ulcerative Colitis (UC) at active phase who are defined to show Ulcerative Colitis-Disease Activitiy Index (UC-DAI) score of 3 or higher but 8 or less, and bloody stool score of 1 or higher

You may not qualify if:

  • Patients with serious or higher according to diagnostic critera of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Hospital

Shanghai, China

Location

Related Publications (1)

  • Sun J, Yuan Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Active Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther. 2016 Mar;33(3):400-9. doi: 10.1007/s12325-016-0303-z. Epub 2016 Feb 22.

    PMID: 26898569DERIVED

MeSH Terms

Interventions

Mesalamine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 9, 2010

Study Start

November 1, 2010

Primary Completion

August 1, 2012

Study Completion

March 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

CN(1)