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Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

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Shire

Status and phase

Completed
Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Asacol
Drug: SPD476

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151892
SPD476-304
2004-004184-29 (EudraCT Number)

Details and patient eligibility

About

Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

Enrollment

829 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
  • female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion criteria

  • proctitis
  • previous resective colonic surgery
  • Crohn's disease
  • hypersensitivity to salicylates
  • moderate/severe renal impairment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

829 participants in 2 patient groups

SPD476
Experimental group
Description:
Mesalazine
Treatment:
Drug: SPD476
Asacol
Active Comparator group
Treatment:
Drug: Asacol

Trial contacts and locations

142

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Data sourced from clinicaltrials.gov

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