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

Primary Purpose

Colitis, Ulcerative, Recurrence

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

mesalamine granules

About this trial

This is an interventional prevention trial for Colitis, Ulcerative focused on measuring maintenance, 5-ASA, mesalamine, mesalazine, ulcerative colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Evangelisches Krankenhaus Kalk, Medical Dept.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

3.0g OD

1.5g OD

0.5g TID

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to relapse

Proportion of patients in endoscopical remission, defined as a mucosal appearance score of ≤ 1 at final/withdrawal examination.

Full Information

NCT ID

NCT00746447

First Posted

September 3, 2008

Last Updated

June 25, 2012

Sponsor

Dr. Falk Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00746447

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Colitis, Ulcerative, Recurrence

Keywords

maintenance, 5-ASA, mesalamine, mesalazine, ulcerative colitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

648 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3.0g OD

Arm Type

Experimental

Arm Title

1.5g OD

Arm Type

Experimental

Arm Title

0.5g TID

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

mesalamine granules

Other Intervention Name(s)

Salofalk granules, Mesalazine

Intervention Description

3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;

Intervention Type

Drug

Intervention Name(s)

mesalamine granules

Other Intervention Name(s)

Salofalk granules, Mesalazine

Intervention Description

1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;

Intervention Type

Drug

Intervention Name(s)

mesalamine granules

Other Intervention Name(s)

Salofalk granules, Mesalazine

Intervention Description

0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time to relapse

Time Frame

within 52 weeks

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Mueller, Dr.

Organizational Affiliation

Dr. Falk Pharma GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Evangelisches Krankenhaus Kalk, Medical Dept.

City

Cologne

ZIP/Postal Code

51103

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21138455

Citation

Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Batovsky M, Lozynsky YS, Zakharash Y, Racz I, Kull K, Vcev A, Faszczyk M, Dilger K, Greinwald R, Mueller R; International Salofalk OD Study Group. Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. Aliment Pharmacol Ther. 2011 Feb;33(3):313-22. doi: 10.1111/j.1365-2036.2010.04537.x. Epub 2010 Dec 8.

Results Reference

result

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

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