Ulcerative Colitis, UnspecifiedPhase 4NCT03110198
Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis
A Phase 4 study testing Mesalazine, hydrocortisone sodium succinate and Mesalazine with hydrocortisone sodium succinate in people with Ulcerative Colitis, Unspecified, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis, Unspecified
- What is being tested?
- Mesalazine, hydrocortisone sodium succinate and Mesalazine with hydrocortisone sodium succinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteChina
- Study dates
- May 2017to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Chinese patients aged ≥18 to ≤ 70 years
- 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.)
- Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy (it should be done within 15 days prior to randomization)
- Total Mayo score of at least 4 and a score of ≥ 2 for colonoscopy
- Oralthe stability dose of 5-ASA medicine 14days.
- Negative stool test at screening to rule out parasites and bacterial pathogens
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- The patient is compliant with Patient Daily Diary
- Women with childbearing potential must have an efficacious contraception as judged by the investigators and must have a negative pregnancy test result at screening
- Signed Informed Consent obtained before any trial-related procedures.
Who cannot join
- Severe/fulminant ulcerative colitis or toxic dilatation of the colon
- Prior bowel resection surgery
- 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)
- Take the following treatment:
- Any 5-ASA enema or suppository therapy during the 14 days prior to screening
- Corticosteroids (oral, intravenous, intramuscular, or rectal ) within 7 days prior to screening
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- Any immunomodulating/suppressive agents during the 60 days prior to screening
- Any Anti-TNF therapy during the 6 months prior to screening
- Antibiotics (metronidazole and ciprofloxacin) within 7 days prior to screening
- Loperamide, nicotine patch and mucilages within 7 days prior to screening
- Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form) within 7 days prior to screening
- Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
- 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
- Women who are planning or actual pregnancy or lactation during study period
- 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)
- Drug addiction confirmed by patients' medical history
- 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
- Patient participating or having participated in another clinical study 30 days prior to screening
- Patient who are unlikely to comply with the protocol as judged by the investigator
- Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures
- Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
- Patients with any other disease or condition which might interfere with study assessment as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Digestive Disease
Xi'an, Shaanxi, 710032
Jie liang, professor, 86-029-84771535, liangjie@fmmu.edu.cn
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis, Unspecified
- Being tested
- Mesalazine, hydrocortisone sodium succinate, Mesalazine with hydrocortisone sodium succinate
- Keywords
- Mesalazine, Ulcerative Colitis(UC), Enema
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalazineDrug
Mesalazine enema rectal administration at bedtime 4g/100 ml, once daily
hydrocortisone sodium succinateDrug
hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily
Mesalazine with hydrocortisone sodium succinateDrug
Mesalazine with hydrocortisone sodium succinate rectal administration at bedtime 4g，100mg/100 ml, once daily for induction of remission
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine with hydrocortisone sodium succinate | Experimental | Mesalazine（4g） with hydrocortisone sodium succinate (100mg ) enema Receives: Drug: Mesalazine with hydrocortisone sodium succinate |
| Mesalazine | Active comparator | Mesalazine （4g）enema Receives: Drug: Mesalazine |
| Hydrocortisone sodium succinate | Active comparator | Hydrocortisone sodium succinate (100mg ) enema Receives: Drug: hydrocortisone sodium succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of clinical remission
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
Measured: 2 weeks, 4 weeks
Secondary outcomes (3)
Change of endoscopic mucosal healing
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
Measured: 2 weeks, 4 weeks
Change of quality of life based on the IBDQ
The change from baseline in Quality of Life at week 2 and 4 of double-blind period based on the IBDQ
Measured: 2 weeks, 4 weeks
Change of mental health by Anxiety and Depression Assessment Scale
Assess mental health by Anxiety and Depression Assessment Scale
Measured: 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, First Affiliated Hospital of Zhongshan Medical University
- Responsible party
- Principal investigator, Jie Liang, Xijing Hospital of Digestive Diseases
- Investigators
- jie Liang, professor, Principal investigator, China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110198
- Sponsor's protocol ID
- KY20162063-1
- Status last verified
- Apr 2017
- First submitted
- 19 Feb 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03110198
- Acronym / sponsor ID
- KY20162063-1
- Conditions
- Ulcerative Colitis, Unspecified
- Keywords
- Mesalazine, Ulcerative Colitis(UC), Enema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, First Affiliated Hospital of Zhongshan Medical University
- Study start
- May 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesalazine with hydrocortisone sodium succinate | Experimental | Drug: Mesalazine with hydrocortisone sodium succinateMesalazine（4g） with hydrocortisone sodium succinate (100mg ) enema |
| Mesalazine | Active comparator | Drug: MesalazineMesalazine （4g）enema |
| Hydrocortisone sodium succinate | Active comparator | Drug: hydrocortisone sodium succinateHydrocortisone sodium succinate (100mg ) enema |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female Chinese patients aged ≥18 to ≤ 70 years
- 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.)
- Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy (it should be done within 15 days prior to randomization)
- Total Mayo score of at least 4 and a score of ≥ 2 for colonoscopy
- Oralthe stability dose of 5-ASA medicine 14days.
Key exclusion criteria (22 listed)
- Severe/fulminant ulcerative colitis or toxic dilatation of the colon
- Prior bowel resection surgery
- 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)
- Take the following treatment:
- Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesalazineMesalazine enema rectal administration at bedtime 4g/100 ml, once daily | Drug | Mesalazine |
| hydrocortisone sodium succinatehydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily | Drug | Hydrocortisone sodium succinate |
| Mesalazine with hydrocortisone sodium succinateMesalazine with hydrocortisone sodium succinate rectal administration at bedtime 4g，100mg/100 ml, once daily for induction of remission | Drug | Mesalazine with hydrocortisone sodium succinate |
Primary outcome
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
3 secondary outcomes
Change of endoscopic mucosal healing
Time frame: 2 weeks, 4 weeks
Change of quality of life based on the IBDQ
Time frame: 2 weeks, 4 weeks
Change of mental health by Anxiety and Depression Assessment Scale
Time frame: 2 weeks, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jie Liang, professor principal investigator
China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mesalazine, hydrocortisone sodium succinate and Mesalazine with hydrocortisone sodium succinate in people with Ulcerative Colitis, Unspecified, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jie Liang, professor (86-029-85771535, liangjie@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of clinical remission (time frame: 2 weeks, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.