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Completed

NCT Number: NCT02368717

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalazine Enema

Drug

Other names: PENTASA® Enema

Placebo Enema

Drug

Primary outcomes

  1. Clinical remission after 4 weeks treatment

    Time frame: At week 4

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

Secondary outcomes

  1. Clinical response after 4 weeks treatment

    Time frame: 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

  2. Change in Quality of Life

    Time frame: From baseline to week 4

    Based on the Inflammatory Bowel Disease Questionnaire (IBDQ)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2015
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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