Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis

April 6, 2017 updated by: Jie Liang, Xijing Hospital of Digestive Diseases

A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)

The research aims to evaluate the efficacy and safety of that mesalazine with hydrocortisone sodium succinate for the induction of clinical remission during a 4-week double-blind treatment period in active UC (define as total Mayo score of greater than or equal to 4 and less than or equal to 10). A total of 528 patients will be randomly divided into three group, one will receive mesalazine 4g with hydrocortisone sodium succinate 100mg enema, and the other two group will respectively to receive mesalazine 4g and hydrocortisone sodium 100mg one times daily for 4 weeks. The end of the study for every patient is the improvement of main symptoms.The primary endpoint is the clinical remission after 2 and 4 weeks double-blind treatment, defined on the basis of a total Mayo score ≤ 2 points, with no subscore > 1 point. The secondary endpoint are endoscopic mucosal healing at week 2 and 4 of double-blind period, defined as an absolute subscore for endoscopy portion of the Mayo score of 0 point and the change from baseline in Quality of Life at week 4 of double-blind period based on the IBDQ.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
528

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Digestive Disease
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female Chinese patients aged ≥18 to ≤ 70 years
  2. Newly diagnosed or recurrent active ulcerative colitis (A gold standard for the diagnosis of ulcerative colitis is not available. The diagnosis should be established by a combination of medical history, clinical evaluation, and typical endoscopic and histological findings. An infective cause should be excluded. Where there is doubt about the diagnosis, endoscopic and histological confirmation is necessary after an interval.)
  3. Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy (it should be done within 15 days prior to randomization)
  4. Total Mayo score of at least 4 and a score of ≥ 2 for colonoscopy
  5. Oralthe stability dose of 5-ASA medicine 14days.
  6. Negative stool test at screening to rule out parasites and bacterial pathogens
  7. The patient is compliant with Patient Daily Diary
  8. Women with childbearing potential must have an efficacious contraception as judged by the investigators and must have a negative pregnancy test result at screening
  9. Signed Informed Consent obtained before any trial-related procedures.

Exclusion Criteria:

  1. Severe/fulminant ulcerative colitis or toxic dilatation of the colon
  2. Prior bowel resection surgery
  3. Known infection of human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV) (Note active Hepatitis B patients should be excluded from the study e.g. HBeAg positive or HBV DNA positive, with the exception for inactive HBsAg carrier)

  4. Take the following treatment:

    1. Any 5-ASA enema or suppository therapy during the 14 days prior to screening
    2. Corticosteroids (oral, intravenous, intramuscular, or rectal ) within 7 days prior to screening
    3. Any immunomodulating/suppressive agents during the 60 days prior to screening
    4. Any Anti-TNF therapy during the 6 months prior to screening
    5. Antibiotics (metronidazole and ciprofloxacin) within 7 days prior to screening
    6. Loperamide, nicotine patch and mucilages within 7 days prior to screening
    7. Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form) within 7 days prior to screening
  5. Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
  6. Known significant hepatic function abnormalities, defined as the values of serum ALT or AST are equal to or more than twice of the upper limit of normal value
  7. Women who are planning or actual pregnancy or lactation during study period
  8. Alcohol addiction (>40 g of alcohol/day equivalent to >1 L of beer/day, 0.5 L of wine/day, or 6 glasses (2 centiliter, cl) of liquor/day)
  9. Drug addiction confirmed by patients' medical history
  10. History of disease that would interfere with their participation in the trial, including malignant diseases, bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, and mental or emotional disorder
  11. Patient participating or having participated in another clinical study 30 days prior to screening
  12. Patient who are unlikely to comply with the protocol as judged by the investigator
  13. Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures
  14. Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
  15. Patients with any other disease or condition which might interfere with study assessment as judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mesalazine with hydrocortisone sodium succinate
Mesalazine（4g） with hydrocortisone sodium succinate (100mg ) enema
Drug: Mesalazine with hydrocortisone sodium succinate
Mesalazine with hydrocortisone sodium succinate rectal administration at bedtime 4g，100mg/100 ml, once daily for induction of remission
Active Comparator: Mesalazine
Mesalazine （4g）enema
Drug: Mesalazine
Mesalazine enema rectal administration at bedtime 4g/100 ml, once daily
Active Comparator: Hydrocortisone sodium succinate
Hydrocortisone sodium succinate (100mg ) enema
Drug: hydrocortisone sodium succinate
hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of clinical remission
Time Frame: 2 weeks, 4 weeks
Clinical remission after 2 and 4 weeks double-blind treatment, defined on the basis of a total Mayo score ≤ 2 points, with no subscore > 1 point
2 weeks, 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of endoscopic mucosal healing
Time Frame: 2 weeks, 4 weeks
endoscopic mucosal healing at week 2 and 4 of double-blind period, defined as an absolute subscore for endoscopy portion of the Mayo score of 0 point
2 weeks, 4 weeks
Change of quality of life based on the IBDQ
Time Frame: 2 weeks, 4 weeks
The change from baseline in Quality of Life at week 2 and 4 of double-blind period based on the IBDQ
2 weeks, 4 weeks
Change of mental health by Anxiety and Depression Assessment Scale
Time Frame: 2 weeks, 4 weeks
Assess mental health by Anxiety and Depression Assessment Scale
2 weeks, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital of Digestive Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Tongji Hospital, Tongji University School of Medicine
First Affiliated Hospital of Zhongshan Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: jie Liang, professor, China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20162063-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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