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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368717
• Other study ID #: 000101
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2015
• Last updated: October 10, 2017
• Start date: March 2015
• Est. completion date: July 25, 2017

Study information

• Verified date: October 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: July 25, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mesalazine Enema

• Placebo Enema

Locations

Country	Name	City	State
China	The 6th hospital affiliated to Zhongshan University (there may be other sites in this country)	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission after 4 weeks treatment	Defined as a total Mayo score =2 points, with no subscore >1 point	At week 4
Secondary	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	At week 4
Secondary	Change in Quality of Life	Based on the Inflammatory Bowel Disease Questionnaire (IBDQ)	From baseline to week 4