Full Text View
Tabular View
No Study Results Posted
Related Studies
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.
Study NCT00746447   Information provided by Dr. Falk Pharma GmbH
First Received: September 3, 2008   No Changes Posted

September 3, 2008
September 3, 2008
May 2005
April 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
 
Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)
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

 
Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Colitis, Ulcerative
  • Recurrence
Drug: mesalamine granules
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
648
March 2008
April 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00746447
Dr. Ralph Mueller - Project Manager Clinical Research & Development, Dr. Falk Pharma GmbH
SAG-27/UCR, EudraCT No.: 2004-001218-15
Dr. Falk Pharma GmbH
 
Study Director: Ralph Mueller, Dr. Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP