Functional DyspepsiaPhase 2NCT03971383
Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients
A Phase 2 study testing Aolanti Weipang Tablets in people with Functional Dyspepsia, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and validity of Aolanti Weipang Tablets in Patients with Postprandial Discomfort Syndrome of Functional Dyspepsia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Aolanti Weipang Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2019to 3 May 2021
- Phase
- Phase 2
- 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
- Patients diagnosed with FD according to the ROME Ⅳ criteria，and must with symptom of bothersome postprandial fullness;
- Patients diagnosed with Stagnation of Qi according to traditional Chinese medicine;
- At least the symptom of bothersome postprandial fullness ≥4 on the Visual Analogue Scale(VAS), and the number of recurrence day must ≥3 in one week;
- Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.
Who cannot join
- The patients with high placebo effect, the scores in placebo run-in stage declined much than 30 percent of the mean VAS per week compare to blank run-in stage;
- Unable to take drugs orally;
- Within 7 days of Screening, the average number of stool > 2 times/day;
- Within 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale;
- History of drug or aurantium allergy;
- Patients with positive in fecal occult blood test;
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- Abnormal liver and/or kidney function: creatinine >1.5*ULN (upper limits of normal), and/or AST and/or ALT > 2.0*ULN, and/or TBil > 1.5*ULN;
- Patients with family history of prolonged QT syndrome or have history of torsional apical ventricular tachycardia; or QTc > 480 ms;
- Digestive diseases, or other diseases within 6 months before Screening that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator;
- Patients who positive in H. Pylori test plan to accept the H. pylori eradication therapy within the trial;
- Serious complications (heart, brain, lung, liver, kidney, or blood disease);
- Neuropsychiatric disorders;
- Use of prohibited medications;
- Pregnant or lactating women or those who are planning to conceive during the study period;
- Drug abuse within 3 months, or alcohol abuse within 6 months;
- Patients participated in other clinical trials within 30 days before taking drugs;
- Other conditions deemed ineligible for enrollment by Investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second People's Hospital of Fujian Province
Fuzhou, Fujian
Xin Yao, +86-13600803702, yjyllbgs@163.com
About this study
Official title: A Multi-Center, Randomized, Double Blind, Placebo-controlled Phase Ⅱc Study of Aolanti Weipang Tablets in Patients With Postprandial Discomfort Syndrome of Functional Dyspepsia to Evaluate the Safety and Validity
The purpose of this study is to evaluate the safety and validity of Aolanti Weipang Tablets in Patients with Postprandial Discomfort Syndrome of Functional Dyspepsia
Read the detailed description
This is a multi-center, randomized, double blind, placebo-controlled phase Ⅱc study to evaluate the safety and validity of Aolanti Weipang Tablets in patients with postprandial discomfort syndrome of Functional Dyspepsia(FD). This study will consecutive about 12 weeks, including 2 weeks of screening, 1 week of blank run-in, 1 week of placebo run-in, 4 weeks of double blind treatment and 4 weeks of observation after treatment. The subjects will be randomly given orally Aolanti Weikang Tablets or placebo tablets at a 1:1 ratio three times a day(tid) with 3 tablets one time for the treatment.
- Conditions
- Functional Dyspepsia
- Being tested
- Aolanti Weipang Tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aolanti Weipang TabletsDrug
3 tablets one time, 3 times a day(tid)
PlaceboDrug
3 tablets one time, 3 times a day(tid)
| Study group | Role | What they receive |
|---|---|---|
| Aolanti Weipang Tablets | Experimental | 3 tablets one time, 3 times a day(tid) Receives: Drug: Aolanti Weipang Tablets |
| Placebo | Placebo comparator | 3 tablets one time, 3 times a day(tid) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate of patient's on the syndrome of postprandial discomfort
the response rate of patients on the syndrome of postprandial discomfort, patient's evaluation of symptomatic improvement by overall treatment efficacy is classified by 7 point Likert scale: Significantly improved Improved Slightly improved No change Slightly worse Worse Much worse And only the Improved and Significantly improved classified as responsed.
Measured: 4 weeks
Secondary outcomes (3)
The response rate of patient's on the syndrome of postprandial discomfort and early satiation
the response rate of patient's on the syndrome of postprandial discomfort and early satiation
Measured: 8 weeks
The response rate of patient's on the syndrome of early satiation
the response rate of patient's on the syndrome of early satiation
Measured: 8 weeks
The safety of Aolanti Weikang Tablets on patients
Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start10 Jun 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion3 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao Ke, Principal investigator, The Second People's Hospital of Fujian Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971383
- Sponsor's protocol ID
- QF-WKP-203
- Status last verified
- May 2019
- First submitted
- 30 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Blind, Placebo-controlled Phase Ⅱc Study of Aolanti Weipang Tablets in Patients With Postprandial Discomfort Syndrome of Functional Dyspepsia to Evaluate the Safety and Validity
- ClinicalTrials.gov ID
- NCT03971383
- Acronym / sponsor ID
- QF-WKP-203
- Conditions
- Functional Dyspepsia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 3 May 2021 (estimated)
- First posted
- 3 Jun 2019 (actual)
- 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 evaluate the safety and validity of Aolanti Weipang Tablets in Patients with Postprandial Discomfort Syndrome of Functional Dyspepsia
Detailed description
This is a multi-center, randomized, double blind, placebo-controlled phase Ⅱc study to evaluate the safety and validity of Aolanti Weipang Tablets in patients with postprandial discomfort syndrome of Functional Dyspepsia(FD). This study will consecutive about 12 weeks, including 2 weeks of screening, 1 week of blank run-in, 1 week of placebo run-in, 4 weeks of double blind treatment and 4 weeks of observation after treatment. The subjects will be randomly given orally Aolanti Weikang Tablets or placebo tablets at a 1:1 ratio three times a day(tid) with 3 tablets one time for the treatment.
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 |
|---|---|---|
| Aolanti Weipang Tablets | Experimental | Drug: Aolanti Weipang Tablets3 tablets one time, 3 times a day(tid) |
| Placebo | Placebo comparator | Drug: Placebo3 tablets one time, 3 times a day(tid) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with FD according to the ROME Ⅳ criteria，and must with symptom of bothersome postprandial fullness;
- Patients diagnosed with Stagnation of Qi according to traditional Chinese medicine;
- At least the symptom of bothersome postprandial fullness ≥4 on the Visual Analogue Scale(VAS), and the number of recurrence day must ≥3 in one week;
- Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.
Key exclusion criteria (17 listed)
- The patients with high placebo effect, the scores in placebo run-in stage declined much than 30 percent of the mean VAS per week compare to blank run-in stage;
- Unable to take drugs orally;
- Within 7 days of Screening, the average number of stool > 2 times/day;
- Within 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale;
- History of drug or aurantium allergy;
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 |
|---|---|---|
| Aolanti Weipang Tablets3 tablets one time, 3 times a day(tid) | Drug | Aolanti Weipang Tablets |
| Placebo3 tablets one time, 3 times a day(tid) | Drug | Placebo |
Primary outcome
The response rate of patient's on the syndrome of postprandial discomfort
Time frame: 4 weeks
the response rate of patients on the syndrome of postprandial discomfort, patient's evaluation of symptomatic improvement by overall treatment efficacy is classified by 7 point Likert scale: Significantly improved Improved Slightly improved No change Slightly worse Worse Much worse And only the Improved and Significantly improved classified as responsed.
3 secondary outcomes
The response rate of patient's on the syndrome of postprandial discomfort and early satiation
Time frame: 8 weeks
The response rate of patient's on the syndrome of early satiation
Time frame: 8 weeks
The safety of Aolanti Weikang Tablets on patients
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Xiao Ke principal investigator
The Second People's Hospital of Fujian Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aolanti Weipang Tablets in people with Functional Dyspepsia, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site 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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinsheng Zhang (+86-18036618691, zhangqinsheng@sh-qingfeng.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate of patient's on the syndrome of postprandial discomfort (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2019.