NCT01745770

Brief Summary

The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2013

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

First Submitted

Initial submission to the registry

December 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2.2 years

First QC Date

December 5, 2012

Last Update Submit

May 30, 2016

Conditions

Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical remission

    Proportion of patients with clinical remission at week 8 compared to baseline. Clinical remission includes normalisation of stool frequency and absence of blood in stools

    8 weeks

Secondary Outcomes (3)

  • Number of stools per week

    8 weeks

  • Number of bloody stools per week

    8 weeks

  • Time to first resolution of clinical symptoms

    8 weeks

Study Arms (2)

A

EXPERIMENTAL
Drug: Mesalazine - TID 1000 mg

B

ACTIVE COMPARATOR
Drug: Mesalazine - TID 2x 500 mg

Interventions

Mesalazine - TID 1000 mgDRUG
A
Mesalazine - TID 2x 500 mgDRUG
B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Men or women aged 18 to 75 years
  • Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology

You may not qualify if:

  • Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis)
  • Toxic megacolon
  • Screening stool positive for germs causing bowel disease
  • Malabsorption syndromes
  • Celiac disease
  • Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med. Klinik 1 - Markus-Krankenhaus

Frankfurt am Main, Hesse, 60431, Germany

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 10, 2012

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

DE(1)