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An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Mesalazine Enema
Placebo Enema
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed or recurrent mild to moderate left-sided active ulcerative colitis
  • Mayo score of at least 4 but not greater than 10 points and a score of ≥ 2 for colonoscopy
  • Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy
  • The patient is compliant with Patient Daily Diary by having adequately responded to the questions on ≥5 of the most recent full 7 days before the Randomization Visit
  • Negative stool test at screening to rule out parasites and bacterial pathogens

Exclusion Criteria:

  • Patients receiving > 2g/day of oral 5-aminosalicylic acid (5-ASA) products, or receiving topical rectal 5-ASA > 3g/week, within 7 days prior to screening
  • Severe/fulminant ulcerative colitis or toxic dilatation of the colon
  • Prior bowel resection surgery
  • Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
  • Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
  • Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures

Sites / Locations

  • The 6th hospital affiliated to Zhongshan University (there may be other sites in this country)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesalazine

Placebo

Arm Description

Mesalazine Enema

Placebo Enema

Outcomes

Primary Outcome Measures

Clinical remission after 4 weeks treatment
Defined as a total Mayo score ≤2 points, with no subscore >1 point

Secondary Outcome Measures

Clinical response after 4 weeks treatment
Defined as a decrease from baseline in total Mayo score ≥3 points and ≥ 30 percent, with an accompanying decrease in the subscore for rectal bleeding ≥ 1 point or an absolute subscore for rectal bleeding of 0 or 1 point
Change in Quality of Life
Based on the Inflammatory Bowel Disease Questionnaire (IBDQ)

Full Information

First Posted
February 16, 2015
Last Updated
October 10, 2017
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02368717
Brief Title
An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 5, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesalazine
Arm Type
Experimental
Arm Description
Mesalazine Enema
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Enema
Intervention Type
Drug
Intervention Name(s)
Mesalazine Enema
Other Intervention Name(s)
PENTASA® Enema
Intervention Type
Drug
Intervention Name(s)
Placebo Enema
Primary Outcome Measure Information:
Title
Clinical remission after 4 weeks treatment
Description
Defined as a total Mayo score ≤2 points, with no subscore >1 point
Time Frame
At week 4
Secondary Outcome Measure Information:
Title
Clinical response after 4 weeks treatment
Description
Defined as a decrease from baseline in total Mayo score ≥3 points and ≥ 30 percent, with an accompanying decrease in the subscore for rectal bleeding ≥ 1 point or an absolute subscore for rectal bleeding of 0 or 1 point
Time Frame
At week 4
Title
Change in Quality of Life
Description
Based on the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
From baseline to week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed or recurrent mild to moderate left-sided active ulcerative colitis Mayo score of at least 4 but not greater than 10 points and a score of ≥ 2 for colonoscopy Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy The patient is compliant with Patient Daily Diary by having adequately responded to the questions on ≥5 of the most recent full 7 days before the Randomization Visit Negative stool test at screening to rule out parasites and bacterial pathogens Exclusion Criteria: Patients receiving > 2g/day of oral 5-aminosalicylic acid (5-ASA) products, or receiving topical rectal 5-ASA > 3g/week, within 7 days prior to screening Severe/fulminant ulcerative colitis or toxic dilatation of the colon Prior bowel resection surgery Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
The 6th hospital affiliated to Zhongshan University (there may be other sites in this country)
City
Guangzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

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