UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021439
Receipt number R000024720
Scientific Title Usefulness of Qing-Dai for active ulcerative colitis
Date of disclosure of the study information 2016/03/11
Last modified on 2017/11/27 21:42:46

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Basic information

Public title

Usefulness of Qing-Dai for active ulcerative colitis

Acronym

Usefulness of Qing-Dai

Scientific Title

Usefulness of Qing-Dai for active ulcerative colitis

Scientific Title:Acronym

Usefulness of Qing-Dai

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of clinical efficacy and safety of Qing-Dai for ulcerative colitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rates of clinical response at week 8
(defined as decrease in the Mayo score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscore or an absolute rectal bleeding subscore of 0 or 1.)

Key secondary outcomes

1) Rates of clinical remission at week 8
2) Changes of the Mayo score between baseline and week 8
3) Rates of endoscopic remission at week 8
4) Changes of the partial Mayo score between baseline and week 4 or week 8
5) Changes of Lichtiger score between baseline and week 4 or week 8
6) Changes of quantitative fecal blood test between baseline and week 8
7) significance of fecal calprotectin level between baseline and week 8

Before we finished to fix the data, some following items of secondary endpoints were added
1) Changes of the CRP, serum ALB between baseline and week2 or, week 4,or week 8
2) Changes of the partial Mayo score, Lichtiger score between baseline and week 2
3) The rate of patients whose quantitative fecal blood test was less than 100 was compared among each group.
4) The rate of patients whose fecal calprotectin test was less than 100 was compared among each group.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Qing-Dai (2g daily) for 8 weeks

Interventions/Control_2

Qing-Dai (1g daily) for 8 weeks

Interventions/Control_3

Qing-Dai (0.5g daily) for 8 weeks

Interventions/Control_4

Placebo for 8 weeks

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Patients who fullfil diagnostic criteria of ulcerative colitis
2 Patients with Mayo score of at least 6 and Mayo endoscopic score of at least 2
3 Patients are at least 16 years of age
4 Written consent is obtained from patients (from legal guardian if patient's age< 20 years old

Key exclusion criteria

1 Patients with severe or fulminate activity
2 Patients with proctitis
3 Patients who have signs of other types of colitis
4 Patients with symptomatic GI stenosis
5 The doctor have a plan to conduct colectomy
6 Patients with a history of side effect or allergy of Chinese herbal medicine, or with previous usage of medication including Qing Dai for ulcerative colitis
7 Patients who have severe infection
8 Patients who have severe heart disease
9 Patients with serum creatinine level of at least 2.0 mg/dL
10 Patients with total bilirubin level of at least 2.0 mg/dL or with ALT/AST levels of at least 50IU/l
11 Patients with a history of malignant diseases
12 Patients with apparent pshycological disorders
13 Pregnant patients, or patients who breast feed to baby or patients who conceive conception
14 Doctor judges inadequate patients to be enrolled into the clinical trial
15 Exclusion criteria of concomittent medication:
Changing the dose of mesalamine within 1 week before the commencement of the study was not allowed.
The patients were not treated with topical mesalamine/steroid within 1 week before the commencement of the study.
The patients were not treated with leukocytapheresis, prednisolone > 40 mg, tacrolimus, cyclosporine, or Chinese herbal medicine within 2 weeks before the commencement of the study.
Concomitant treatment with thiopurine, started more than 4 weeks before the commencement of the study, was allowed if that dosage had been stable for at least 4 weeks before the study was conducted.
The patients were not treated with adalimumab within 4 weeks or infliximab within 8 weeks before the commencement of the study.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanori Kanai

Organization

School of Medicine, Keio University

Division name

Department of Gastroenterology and Hematology

Zip code


Address

35 Shinanomachi, Shunjuku-ku, Tokyo

TEL

03-3353-1211

Email

takagast@z2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Naganuma

Organization

School of Medicine, Keio University

Division name

Department of Gastroenterology and Hematology

Zip code


Address

35 Shinanomachi, Shunjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

nagamakoto@z7.keio.jp


Sponsor or person

Institute

School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.gastrojournal.org/article/S0016-5085(17)36382-5/fulltext

Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 12 Day

Last follow-up date

2017 Year 02 Month 10 Day

Date of closure to data entry

2017 Year 02 Month 22 Day

Date trial data considered complete

2017 Year 03 Month 06 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 11 Day

Last modified on

2017 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024720


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name