NCT01257399

Brief Summary

To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 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
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 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

2.2 years

First QC Date

December 8, 2010

Last Update Submit

April 3, 2013

Conditions

Ulcerative Colitis in Remission

Outcome Measures

Primary Outcomes (1)

  • Rate of non-emergence of bloody stool

    Week 48

Secondary Outcomes (1)

  • 1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score

    Week 48

Study Arms (2)

Asacol®

EXPERIMENTAL

Import Mesalazine

Drug: Asacol®

Mesalazine

ACTIVE COMPARATOR

Marketed Mesalazine

Drug: Mesalazine

Interventions

Asacol®DRUG

400 mg 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 in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0.

You may not qualify if:

  • Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.

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 Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther. 2016 Mar;33(3):410-22. doi: 10.1007/s12325-016-0304-y. Epub 2016 Feb 23.

    PMID: 26905266DERIVED

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

January 1, 2013

Study Completion

March 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

CN(1)