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CompletedNCT01355276Updated Nov 30, 2011

Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

A Phase 3 interventional study of Cinitapride and domperidone in Dyspepsia, sponsored by Eisai China Inc.. Completed at 13 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-11-30.

Sponsored by Eisai China Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to compare Cinitapride tablets with domperidone tablets (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment of mild to moderate functional dyspepsia.

02

Conditions studied

  • Dyspepsia

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Keywords

  • Cinitapride
  • efficacy
  • safety
  • mild to moderate functional dyspepsia
03

In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's enrollment of 400 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Eisai China Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged between 18\~65 years, both males and females;
  2. Patients with symptoms of mild to moderate functional dyspepsia;
  3. Symptoms related to dyspepsia were developed 6 months ago and early satiety or/and discomfort after meal were developed in the past 3 months;
  4. Gastrointestinal malignancy, peptic ulcer, liver, gallbladder and pancreas diseases were excluded through gastroscopy, B-ultrasonography and laboratory examination within 4 weeks prior to administration (endoscopy results considered to be clinically unrelated will not be excluded, such as small hiatal hernia and chronic nonatrophic pangastritis);
  5. Patient has signed informed consent form.

Exclusion criteria

Exclusion criteria

  1. Patients with gastroesophageal reflux and/or irritable bowel syndrome;
  2. Acid regurgitation more than once per week;
  3. Previously received abdominal surgery (except appendectomy and herniorrhaphy);
  4. A history of gastric or duodenal ulcer;
  5. Patients with depression and anxiety neurosis;
  6. Patients with arrhythmia;
  7. QTc more than 0.5s;
  8. Hepatic and renal insufficiency: AST or/and ALT equal to or above 1.5 times of the upper normal limit; Cr above the upper normal limit;
  9. Pathological lactorrhea;
  10. Patients with alcohol abuse (daily alcohol intake more than 40g), drug dependence or neuropsychiatric disorders that are difficult to control, as well as others who are not appropriate to participate in a drug trial;
  11. Pregnant or lactating women;
  12. Patients who require other therapy to change gastrointestinal mobility;
  13. Patients who are participating or participated in other drug clinical trial within 3 months prior to entry;
  14. Known to be allergic to cinitapride; Patients who are considered by investigators to be inappropriate to participate.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    1

    Drug: Cinitapride

  • Active comparator
    2

    Drug: domperidone

Interventions

  • DrugCinitapride

    cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks

  • Drugdomperidone

    10 mg for each dose ,30 mg/daily, for 4 weeks

06

What researchers measure

Primary outcomes

  1. Response rate of overall symptom improvement after 4-weeks treatment

    Time frame: 4 weeks

Secondary outcomes

  1. Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment

    Time frame: 2 and 4 weeks

  2. Response rate after 2 weeks treatment

    Time frame: 2 weeks

  3. Percentage change of individual symptom score (early satiety, discomfort with fullness after meal, flatulence, epigastric pain, epigastric burning, nausea, vomiting and belching) after 2 and 4 weeks treatment compared with the baseline

    Time frame: 2 and 4 weeks

  4. Changes of gastric emptying in some patients after 4-week treatment

    Time frame: 4 weeks

  5. Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment

    Time frame: 2 and 4 weeks

07

Study locations

13 sites
  • The First Affiliated Hospital of Anhui medical university
    Hefei, Anhui, China
  • Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School
    Wuhan, Hubei, China
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei, China
  • Changzhou First People?s Hospital
    Changzhou, Jiangsu, China
  • Nanjing First Hospital
    Nanjing, Jiangsu, China
  • Wuxi No.2 People's Hospital
    Wuxi, Jiangsu, China
  • Wuxi People's Hospital
    Wuxi, Jiangsu, China
  • Yangzhou First People's Hospital
    Yangzhou, Jiangsu, China
  • Changhai Hospital
    Shanghai, China
  • Shanghai Changzheng Hospital
    Shanghai, China
  • The Second Affiliated Hospital of Suzhou University
    Suzhou, China
  • The Second Hospital of Tianjin Medical University
    Tianjin, China
  • Tianjin Medical University General Hospital
    Tianjin, China
08

References and documents

Publications

  • Du Y, Su T, Song X, Gao J, Zou D, Zuo C, Xie W, Wang B, Zhang Z, Xu J, Tian D, Luo H, Zhang Z, Wang S, Chen J, Guo J, Gong L, Ding Y, Li Z. Efficacy and safety of cinitapride in the treatment of mild to moderate postprandial distress syndrome-predominant functional dyspepsia. J Clin Gastroenterol. 2014 Apr;48(4):328-35. doi: 10.1097/MCG.0000000000000033. PubMed 24440931 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01355276
Lead sponsor
Eisai China Inc.
Responsible party
Sponsor
First posted
May 18, 2011
Start date
Oct 2010
Primary completion
Jun 2011
Completion
Oct 2011
Last update
Nov 30, 2011

Study contacts

Zhaoshen Li
principal investigator · Changhai Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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