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Wilmington, North Carolina

  • Ulcerative Colitis

Purpose:

The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.


Criteria:

Inclusion Criteria: - Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission Exclusion Criteria: - Evidence of other forms of inflammatory bowel disease - Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]) - Disease limited to proctitis <15 cm - Short bowel syndrome - Prior colon resection surgery - History of severe/fulminant UC - 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 of 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


Study is Available At:


Original ID:

000175


NCT ID:

NCT02522780


Secondary ID:

2015-002558-11


Study Acronym:


Brief Title:

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)


Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ferring Pharmaceuticals


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

276


Enrollment Type:

Actual


Overall Contact Information

Official Name:Global Clinical Compliance
Study Director
Ferring Pharmaceuticals

Study Dates

Start Date:February 1, 2016
Completion Date:September 19, 2018
Completion Type:Actual
Primary Completion Date:September 19, 2018
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 4, 2019
First Received Date:August 12, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Proportion of subjects in remission
Time Frame:At Month 6
Safety Issues:False
Description:Defined by the Clinical and Endoscopic Response Score based on a modified 9 point Mayo score
Outcome Type:Secondary Outcome
Measure:Proportion of subjects in clinical remission
Time Frame:Up to Month 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to relapse
Time Frame:Up to Month 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Severity of adverse events
Time Frame:Up to Month 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of adverse events
Time Frame:Up to Month 6
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Mesalamine
Description:Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Arm Name:Mesalamine
Other Name:Mesalazine
Intervention Type:Drug
Name:Placebo
Description:Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Mesalamine
Description:Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ferring Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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