Trial record 43 of 2056 for:    digestive | Open Studies | Exclude Unknown | United States

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02522767
First received: August 12, 2015
Last updated: May 11, 2016
Last verified: May 2016
  Purpose
The purpose of this trial is to investigate the safety and 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.

Condition Intervention Phase
Ulcerative Colitis
Drug: Mesalamine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of subjects with remission [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
    Defined by the Clinical and Endoscopic Response Score based on a modified 9 point Mayo score


Secondary Outcome Measures:
  • Proportion of subjects with remission in the primary endpoint and the Physician's Global Assessment (PGA) [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
  • Time to cessation of rectal bleeding [ Time Frame: Up to Week 8 ] [ Designated as safety issue: No ]
  • Severity of adverse events [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: October 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesalamine
4 g extended release granules (sachet)
Drug: Mesalamine
Other Names:
  • Mesalazine
  • Pentasa
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02522767

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

  Show 73 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02522767     History of Changes
Other Study ID Numbers: 000174  2015-002557-35 
Study First Received: August 12, 2015
Last Updated: May 11, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Canada: Health Canada
Israel: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Switzerland: Federal Office of Public Health
Ukraine: Ministry of Health
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 30, 2016