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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000326
Receipt No. 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

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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
Institute Japanese Sciety for treatment of Functional dyspepsia
Institute
Department

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
URL(English) https://upload.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


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