Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00746447
First received: September 3, 2008
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Colitis, Ulcerative
Recurrence
 Drug: mesalamine granules
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dr. Falk Pharma GmbH:

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. [ Time Frame: week 52 or premature withdrawal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to relapse [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 648
Study Start Date: May 2005
Study Completion Date: March 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Salofalk granules
  • Mesalazine
Experimental: 1.5g OD 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:
  • Salofalk granules
  • Mesalazine
Active Comparator: 0.5g TID 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:
  • Salofalk granules
  • Mesalazine

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746447

Locations
Germany
Evangelisches Krankenhaus Kalk, Medical Dept.
Cologne, Germany, 51103
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Study Director: Ralph Mueller, Dr. Dr. Falk Pharma GmbH
  More Information

Publications:

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT00746447     History of Changes
Other Study ID Numbers: SAG-27/UCR, EudraCT No.: 2004-001218-15
Study First Received: September 3, 2008
Last Updated: June 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:
maintenance
5-ASA
mesalamine
mesalazine
ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Recurrence
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Disease Attributes
Pathologic Processes
 Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013