DyspepsiaPhase 3NCT01355276
Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
A Phase 3 study testing Cinitapride and domperidone in people with Dyspepsia, run by Eisai China Inc. at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Cinitapride and domperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 13 sitesChina
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18~65 years, both males and females;
- Patients with symptoms of mild to moderate functional dyspepsia;
- Symptoms related to dyspepsia were developed 6 months ago and early satiety or/and discomfort after meal were developed in the past 3 months;
- 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);
- Patient has signed informed consent form.
Who cannot join
- Patients with gastroesophageal reflux and/or irritable bowel syndrome;
- Acid regurgitation more than once per week;
- Previously received abdominal surgery (except appendectomy and herniorrhaphy);
- A history of gastric or duodenal ulcer;
- Patients with depression and anxiety neurosis;
- Patients with arrhythmia;
Show all 14Show fewer
- QTc more than 0.5s;
- 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;
- Pathological lactorrhea;
- 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;
- Pregnant or lactating women;
- Patients who require other therapy to change gastrointestinal mobility;
- Patients who are participating or participated in other drug clinical trial within 3 months prior to entry;
- Known to be allergic to cinitapride; Patients who are considered by investigators to be inappropriate to participate.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Changzhou First People?s Hospital
Changzhou, Jiangsu
The First Affiliated Hospital of Anhui medical university
Hefei, Anhui
Nanjing First Hospital
Nanjing, Jiangsu
Changhai Hospital
Shanghai
Shanghai Changzheng Hospital
Shanghai
The Second Affiliated Hospital of Suzhou University
Suzhou
The Second Hospital of Tianjin Medical University
Tianjin
Tianjin Medical University General Hospital
Tianjin
Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School
Wuhan, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei
Wuxi No.2 People's Hospital
Wuxi, Jiangsu
Wuxi People's Hospital
Wuxi, Jiangsu
Yangzhou First People's Hospital
Yangzhou, Jiangsu
About this study
Official title: A Randomized, Double-blind, Double-dummy, Active Drug Parallel Controlled, Multi-center Clinical Trial on the Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
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.
- Conditions
- Dyspepsia
- Being tested
- Cinitapride, domperidone
- Keywords
- Cinitapride, efficacy, safety, mild to moderate functional dyspepsia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinitaprideDrug
cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
domperidoneDrug
10 mg for each dose ,30 mg/daily, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Cinitapride |
| 2 | Active comparator | Not described Receives: Drug: domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of overall symptom improvement after 4-weeks treatment
Measured: 4 weeks
Secondary outcomes (5)
Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment
Measured: 2 and 4 weeks
Response rate after 2 weeks treatment
Measured: 2 weeks
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
Measured: 2 and 4 weeks
Changes of gastric emptying in some patients after 4-week treatment
Measured: 4 weeks
Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment
Measured: 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai China Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355276
- Sponsor's protocol ID
- CYWC100602
- Status last verified
- Nov 2011
- First submitted
- 16 May 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Active Drug Parallel Controlled, Multi-center Clinical Trial on the Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01355276
- Acronym / sponsor ID
- CYWC100602
- Conditions
- Dyspepsia
- Keywords
- Cinitapride, efficacy, safety, mild to moderate functional dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Eisai China Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cinitapride |
| 2 | Active comparator | Drug: domperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18~65 years, both males and females;
- Patients with symptoms of mild to moderate functional dyspepsia;
- Symptoms related to dyspepsia were developed 6 months ago and early satiety or/and discomfort after meal were developed in the past 3 months;
- 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);
- Patient has signed informed consent form.
Key exclusion criteria (14 listed)
- Patients with gastroesophageal reflux and/or irritable bowel syndrome;
- Acid regurgitation more than once per week;
- Previously received abdominal surgery (except appendectomy and herniorrhaphy);
- A history of gastric or duodenal ulcer;
- Patients with depression and anxiety neurosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinitapridecinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks | Drug | 1 |
| domperidone10 mg for each dose ,30 mg/daily, for 4 weeks | Drug | 2 |
Primary outcome
Response rate of overall symptom improvement after 4-weeks treatment
Time frame: 4 weeks
5 secondary outcomes
Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment
Time frame: 2 and 4 weeks
Response rate after 2 weeks treatment
Time frame: 2 weeks
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
Changes of gastric emptying in some patients after 4-week treatment
Time frame: 4 weeks
Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment
Time frame: 2 and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
- Derived from this study: PubMed 24440931Du 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoshen Li principal investigator
Changhai Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinitapride and domperidone in people with Dyspepsia, run by Eisai China Inc. at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of overall symptom improvement after 4-weeks treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.