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Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

Primary Purpose

Ulcerative Colitis in Remission

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Asacol®
Mesalazine
Sponsored by
Tillotts Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis in Remission

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Shanghai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asacol®

Mesalazine

Arm Description

Import Mesalazine

Marketed Mesalazine

Outcomes

Primary Outcome Measures

Rate of non-emergence of bloody stool

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2010
Last Updated
April 3, 2013
Sponsor
Tillotts Pharma AG
Collaborators
Zeria Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01257399
Brief Title
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
Official Title
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tillotts Pharma AG
Collaborators
Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis in Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asacol®
Arm Type
Experimental
Arm Description
Import Mesalazine
Arm Title
Mesalazine
Arm Type
Active Comparator
Arm Description
Marketed Mesalazine
Intervention Type
Drug
Intervention Name(s)
Asacol®
Other Intervention Name(s)
Import Mesalazine
Intervention Description
400 mg tablets
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Other Intervention Name(s)
Marketed Mesalazine
Intervention Description
400mg tablets
Primary Outcome Measure Information:
Title
Rate of non-emergence of bloody stool
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Shanghai Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26905266
Citation
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.
Results Reference
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Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

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