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

Dr. Falk Pharma

Status and phase

Completed

Phase 3

Conditions

Colitis, Ulcerative

Recurrence

Treatments

Drug: mesalamine granules

Study type

Interventional

Funder types

Industry

Identifiers

NCT00746447

EudraCT No.: 2004-001218-15

SAG-27/UCR

Details and patient eligibility

About

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

Enrollment

648 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.