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Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

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Ferring

Status and phase

Completed
Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Mesalamine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02522767
000174
2015-002557-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.

Enrollment

228 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female subjects aged 18 to 75 years
  • Mild to moderate UC

Exclusion criteria

  • Disease limited to proctitis <15 cm
  • Short bowel syndrome
  • Prior colon resection surgery
  • History of severe/fulminant UC
  • Evidence of other forms of inflammatory bowel disease
  • Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
  • Intolerant or allergic to aspirin or salicylate derivatives
  • Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
  • Women who are pregnant or nursing
  • History or known malignancy
  • History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

228 participants in 2 patient groups, including a placebo group

Mesalamine
Experimental group
Description:
4 g extended release granules (sachet)
Treatment:
Drug: Mesalamine
Placebo
Placebo Comparator group
Description:
Matching placebo
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

93

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Data sourced from clinicaltrials.gov

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