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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02368717

Enrollment

281

Registered

2015-02-23

Start date

2015-03-31

Completion date

2017-07-25

Last updated

2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

DRUGMesalazine Enema

DRUGPlacebo Enema

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Change in Quality of Life	From baseline to week 4	Based on the Inflammatory Bowel Disease Questionnaire (IBDQ)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026