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

NCT02368717 | Completed Phase 3

• 1 other identifier: 000101
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical remission after 4 weeks treatment

  Defined as a total Mayo score ≤2 points, with no subscore \>1 point

  At week 4

Secondary Outcomes (2)

• Clinical response after 4 weeks treatment

  At week 4

• Change in Quality of Life

  From baseline to week 4

Study Arms (2)

Mesalazine

EXPERIMENTAL

Mesalazine Enema

Drug: Mesalazine Enema

Placebo

PLACEBO COMPARATOR

Placebo Enema

Drug: Placebo Enema

Interventions

Mesalazine Enema DRUG

Also known as: PENTASA® Enema

Mesalazine

Placebo Enema DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

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

Guangzhou, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: February 23, 2015
• Study Start: March 1, 2015
• Primary Completion: January 5, 2017
• Study Completion: July 25, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

CN (1)