UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000326
Receipt number R000000388
Scientific Title Effect of tadospirone citrate on symptom resolution of patients with functional dyspepsia - A double-blind placebo-controlled trial
Date of disclosure of the study information 2006/02/07
Last modified on 2009/10/26 18:54:11

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Basic information

Public title

Effect of tadospirone citrate on symptom resolution of patients with functional dyspepsia - A double-blind placebo-controlled trial

Acronym

Effect of Tandospirone Citrate for FD patients

Scientific Title

Effect of tadospirone citrate on symptom resolution of patients with functional dyspepsia - A double-blind placebo-controlled trial

Scientific Title:Acronym

Effect of Tandospirone Citrate for FD patients

Region

Japan


Condition

Condition

Functional dyspepsia

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of novel treatment for FD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

symptom resolution (improvement)

Key secondary outcomes

imprvement of quality of eibe


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of anti-anxiety drug )Tandospirone Citrate) 30mg/day for one month

Interventions/Control_2

placebo

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

FD patients who meet Rome II criteria
1. patients who had at least one symptom described below in one week preceding the study pain, discomfort of epigastrium, bloating, abdominal fullness, early satiety, nausea or vomiting, appetite loss, belching.
2. patients who had no organic lesions that were confirmed by upper GI endoscopy within 6 months.
3. patients who are older than 20 years at entry.
4. out patients.
5. patients who understand the study contents and give informed consents by themselves

Key exclusion criteria

1. patients who have obvious organic lesions such as malignancy, or peptic ulcers.
2. patients who have obvious causes for the symptoms such as overeating.
3. patients whose main symptom is heartburn.
4. patients who are or ore suspected IBS.
5. patients who have past history of surgery for upper GI diseases.
6. patients who have pathological anxiety, depression or obvious mental diseases.
7. patients with severe liver and renal diseases.
8. patients who took medicines described below within one week before the first day of the study; prokinetics, acid -inhibitory drugs (H2RA, PPI), PG drugs NSAIDs.
9. patients who took anti-anxiety drug or tranquilizer within 4 weeks before beginning of the study.
10. patients who are pregnancy, in breast-feeding or who wish pregnancy during the study period.
11. patients who are regarded in-eligible by the doctor who participates in this study.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroto Miwa

Organization

Hyogo college of Medicine

Division name

Upper gastroenterology Department of internal medicine

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6665

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Japanese Sciety for treatment of Functional dyspepsia

Division name

secretariat

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6665

Homepage URL

http://www.hyo-med.ac.jp/department/gstr/fd_top.htm

Email

j-fd@hyo-med.ac.jp


Sponsor or person

Institute

Japanese Sciety for treatment of Functional dyspepsia

Institute

Department

Personal name



Funding Source

Organization

The waksman foundation of japan inc.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2006 Year 02 Month 07 Day


Related information

URL releasing protocol

http://www.hyo-med.ac.jp/department/gstr/fd_top.htm

Publication of results

Published


Result

URL related to results and publications

http://www.nature.com/ajg/journal/vaop/ncurrent/abs/ajg2009427a.html

Number of participants that the trial has enrolled


Results

Objective: Functional dyspepsia is a common condition in the general population, however its treatment remains a challenge. The aim of this study was to examine the efficacy of tandospirone citrate, a new partial agonist of the 5-HT1A receptor, in improving the symptoms of patients with functional dyspepsia (FD).
Methods: In this double-blind, placebo-controlled, multicenter study, FD patients were randomized treatment with 10 mg tid tandospirone citrate or placebo for 4 weeks. The primary endpoint was change in abdominal symptom scores. The difference in proportion of responders (a total abdominal symptom score of 0 or 1) was also assessed. The quality of life questionnaire, the SF-8 and a psychological test questionnaire, the State-Trait Anxiety Inventory (STAI) were completed at baseline and weekly intervals.
Results: Data were available on 144 patients: 73 for tandospirone and 71 for placebo. Improvements in total abdominal scores were significantly larger with tandospirone than placebo at week 1, 2 and 4. Significantly greater improvements in the tandospirone group were observed in upper abdominal pain (p = 0.02) and discomfort (p =0.002) at week 4. The proportion of responders was significantly greater in the active treatment arm at week 3 (p=0.017) and 4 (p = 0.0016). Significant improvements in STAI (p < 0.0001) were reported in both arms as well as in the majority of questions in the SF-8 (p = 0.04). No serious adverse events were reported, with similar rates in both study arms.
Conclusions: Despite a considerable placebo effect, the benefits of tandospirone were demonstrated in terms of improvement in abdominal symptom scores.

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

Completed

Date of protocol fixation

2005 Year 10 Month 29 Day

Date of IRB


Anticipated trial start date

2005 Year 12 Month 01 Day

Last follow-up date

2006 Year 08 Month 01 Day

Date of closure to data entry

2006 Year 10 Month 01 Day

Date trial data considered complete

2007 Year 04 Month 01 Day

Date analysis concluded

2007 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 02 Month 07 Day

Last modified on

2009 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000388


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name