Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)

June 25, 2012 updated by: Dr. Falk Pharma GmbH

Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis

This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

648

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 51103
        • Evangelisches Krankenhaus Kalk, Medical Dept.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent,
  • Men or women aged 18 to 75 years,
  • Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology,
  • Patient being in remission, defined (according to Rachmilewitz) as:

Clinical Activity Index (CAI) <= 4, and Endoscopic Index (EI) < 4,

  • Extent of inflammation during last acute episode was >15 cm beyond the anal margin,
  • Last acute episode ended within 3 months prior to study entry.

Exclusion Criteria:

  • Crohn's disease,
  • Prior bowel resection leading to diarrhoea,
  • Toxic megacolon,
  • Gastric or duodenal ulcer,
  • Haemorrhagic diathesis,
  • Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of haemorrhoids or hiatal hernia),
  • Active colorectal cancer or a history of colorectal cancer,
  • Serious other secondary illnesses of an acute or chronic nature,
  • Asthma,
  • Severe impairment of renal (e.g., serum creatinine > 1.5 mg/dl) and/or liver functions (e.g., serum transaminase [ALT and/or AST] or alkaline phosphatase >=2x upper limit of normal [ULN]),
  • Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to baseline,
  • Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment (i.e. > 6 weeks), other than acetylsalicylic acid (<= 350 mg/day), or paracetamol,
  • Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs,
  • Well-founded doubt about the patient's cooperation,
  • Existing or intended pregnancy, breast-feeding,
  • Women of child-bearing potential without adequate contraceptive protection, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation,
  • Participation in another clinical trial within the last 30 days,simultaneous participation in another clinical trial, or previous participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3.0g OD
Drug: mesalamine granules
3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Mesalazine
  • Salofalk granules
Drug: mesalamine granules
1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Mesalazine
  • Salofalk granules
Drug: mesalamine granules
0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening
Other Names:
  • Mesalazine
  • Salofalk granules
Experimental: 1.5g OD
Drug: mesalamine granules
3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Mesalazine
  • Salofalk granules
Drug: mesalamine granules
1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Mesalazine
  • Salofalk granules
Drug: mesalamine granules
0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening
Other Names:
  • Mesalazine
  • Salofalk granules
Active Comparator: 0.5g TID
Drug: mesalamine granules
3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Mesalazine
  • Salofalk granules
Drug: mesalamine granules
1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Mesalazine
  • Salofalk granules
Drug: mesalamine granules
0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening
Other Names:
  • Mesalazine
  • Salofalk granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients still in clinical remission at the final/withdrawal examination, with clinical relapse defined as a CAI >4 with an increase of ≥3 points from baseline.
Time Frame: week 52 or premature withdrawal
week 52 or premature withdrawal

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to relapse
Time Frame: within 52 weeks
within 52 weeks
Proportion of patients in endoscopical remission, defined as a mucosal appearance score of ≤ 1 at final/withdrawal examination.
Time Frame: week 52 or premature withdrawal
week 52 or premature withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Study Director: Ralph Mueller, Dr., Dr. Falk Pharma GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAG-27/UCR
  • EudraCT No.: 2004-001218-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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