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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02368717
• Date of registration: 16/02/2015
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public 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
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 281
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02368717
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo Enema

Drug: Mesalazine Enema

Primary Outcome(s)

Clinical remission after 4 weeks treatment [Time Frame: At week 4]

Secondary Outcome(s)

Change in Quality of Life [Time Frame: From baseline to week 4]

Clinical response after 4 weeks treatment [Time Frame: At week 4]

Secondary ID(s)

000101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors