Unique ID issued by UMIN | C000000326 |
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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 |
Effect of tadospirone citrate on symptom resolution of patients with functional dyspepsia - A double-blind placebo-controlled trial
Effect of Tandospirone Citrate for FD patients
Effect of tadospirone citrate on symptom resolution of patients with functional dyspepsia - A double-blind placebo-controlled trial
Effect of Tandospirone Citrate for FD patients
Japan |
Functional dyspepsia
Gastroenterology |
Others
NO
Development of novel treatment for FD
Efficacy
Confirmatory
Explanatory
Phase IV
symptom resolution (improvement)
imprvement of quality of eibe
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is considered as a block.
YES
No need to know
2
Treatment
Medicine |
Administration of anti-anxiety drug )Tandospirone Citrate) 30mg/day for one month
placebo
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
150
1st name | |
Middle name | |
Last name | Hiroto Miwa |
Hyogo college of Medicine
Upper gastroenterology Department of internal medicine
1-1 Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6665
1st name | |
Middle name | |
Last name |
Japanese Sciety for treatment of Functional dyspepsia
secretariat
1-1 Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6665
http://www.hyo-med.ac.jp/department/gstr/fd_top.htm
j-fd@hyo-med.ac.jp
Japanese Sciety for treatment of Functional dyspepsia
The waksman foundation of japan inc.
Non profit foundation
Japan
NO
2006 | Year | 02 | Month | 07 | Day |
http://www.hyo-med.ac.jp/department/gstr/fd_top.htm
Published
http://www.nature.com/ajg/journal/vaop/ncurrent/abs/ajg2009427a.html
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.
Completed
2005 | Year | 10 | Month | 29 | Day |
2005 | Year | 12 | Month | 01 | Day |
2006 | Year | 08 | Month | 01 | Day |
2006 | Year | 10 | Month | 01 | Day |
2007 | Year | 04 | Month | 01 | Day |
2007 | Year | 10 | Month | 01 | Day |
2006 | Year | 02 | Month | 07 | Day |
2009 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000388
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