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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Colitis, Ulcerative Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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3.0g OD

Group Type EXPERIMENTAL

mesalamine granules

Intervention Type DRUG

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

1.5g OD

Group Type EXPERIMENTAL

mesalamine granules

Intervention Type DRUG

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

0.5g TID

Group Type ACTIVE_COMPARATOR

mesalamine granules

Intervention Type DRUG

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

Interventions

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mesalamine granules

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

Intervention Type DRUG

mesalamine granules

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

Intervention Type DRUG

mesalamine granules

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

Intervention Type DRUG

Other Intervention Names

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Salofalk granules Mesalazine Salofalk granules Mesalazine Salofalk granules Mesalazine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No