Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
NCT ID: NCT03689673
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
607 participants
OBSERVATIONAL
2013-04-24
2020-11-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
NCT02537210
Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA
NCT01654783
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
NCT00209300
A Single-Center Observational Study on the Impact of Symptom Assessment Timing on the Short-Term Efficacy of 5-ASA Therapy in Patients With Initial-Onset or Relapsed Mild-to-Moderate Active Ulcerative Colitis
NCT06998693
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Data collection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has provided written informed consent to participate in the study after the purpose and nature have been clearly explained to him/her;
* Patient with documented diagnosis of mild-moderate Ulcerative Colitis (UC). The "documented diagnosis" should include a typical histology observed at least once in the course of the disease;
* Have a documented history of UC that has been successfully maintained in complete steroid-free remission for at least 1 month prior to study entry;
* The modified mayo score ≤ 2, without subscore \>1, which is supported by a rectum-sigmoidoscopy or a colonoscopy;
* Regimen of maintenance of remission contains Etiasa®
* Patient mentally and physically able to answer the questionnaire.
Exclusion Criteria
* Pregnant and breastfeeding women, approaching childbirth female or unwilling to take birth control measures during the study;
* A topical 5-aminosalicylate agent is included in the regimen;
* Patients with infectious colitis (positive for germs, ovum or parasites causing bowel disease);
* Treated with the other study drug at enrollment, or within past 3 months of enrollment;
* Serious underlying disease other than UC which in the opinion of the investigator may interfere with the patient's ability to participate fully in the study;
* Crohn's disease;
* Pancreatitis;
* Known bleeding disorders;
* Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ipsen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Affiliated Beijing Chao-yang Hospital of Capital Medical University
Beijing, , China
Peking University First Hospital
Beijing, , China
China-Japan Union Hospital of Jilin University
Changchun, , China
The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA
Chongqing, , China
The First Affiliated Hospital of Dalian Medical University
Dalian, , China
The First Affiliated Hospital of Sun Yatsen University
Guangzhou, , China
Nanfang Hospital of Southern Medical University
Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yatsen University
Guangzhou, , China
Hebi People Hospital
Hebi, , China
Anhui Provincial Hospital
Hefei, , China
Henan Province People Hospital
Henan, , China
The PLA 150 Central Hospital
Luoyang, , China
The First Affiliated hospital of Nan Chang University
Nanchang, , China
Nanjing General Hospital of Nanjing Military Command
Nanjing, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Jiangsu Province Hospital of TCM
Nanjing, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Qingdao Municipal Hospital
Qingdao, , China
Suzhou Third People Hospital
Suzhou, , China
The second affiliated hospital of Suzhou University
Suzhou, , China
Tianjin People's Hospital
Tianjin, , China
The Second Hospital Affiliated to Wenzhou Medical College
Wenzhou, , China
Union Hospital Affiliated to Tongji Medical College
Wuhan, , China
The People's Hospital of Wuhan University
Wuhan, , China
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A-38-58216-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.