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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mesalazine Enema; Drug: Placebo Enema

• Registration Number: NCT02368717
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-02-16
• Study First Posted: 2015-02-23
• Study Start: 2015-03
• Primary Completion: 2017-01-05
• Study Completion: 2017-07-25
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesalazine	Mesalazine Enema	Mesalazine Enema
Placebo	Placebo Enema	Placebo Enema

Primary Outcome Measures

Name	Time	Method
Clinical remission after 4 weeks treatment	At week 4	Defined as a total Mayo score ≤2 points, with no subscore \>1 point

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	From baseline to week 4	Based on the Inflammatory Bowel Disease Questionnaire (IBDQ)
Clinical response after 4 weeks treatment	At week 4	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

Trial Locations

Locations (1)

The 6th hospital affiliated to Zhongshan University (there may be other sites in this country); 🇨🇳 Guangzhou, China