Functional DyspepsiaPhase 1NCT03358485
Study of Aolanti Weikang Tablets in Healthy Volunteers
A Phase 1 study testing Aolanti Weikang 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 tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Aolanti Weikang tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2017to 30 Jun 2018
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) :≥19 and ≤26 kg/m2
- Signed written informed consent
Who cannot join
- With in 7 days of Screening, the average number of stool > 2 times/day
- With in 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale
- At least one clinically significant abnormality based the comprehensive examination (including vital signs, physical examination, laboratory examination and others)
- Digestive diseases, or other diseases within 3 months that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator
- Smoking, alcohol abuse or drug abuse with in 3 months or drinking within 48 hours before the first administration
- History of drug or aurantium allergy
Show all 12Show fewer
- Concomitant medication within 2 weeks prior to drug administration or any drug being used
- Participated in other clinical trials within 3 months before Screening
- Major surgery/surgical therapy for any cause within 4 weeks of Screening, or scheduled surgeries within 2 weeks after the last dose of study drug
- Subjects not agree to use adequate contraception from study entry through at least 28 days after the last dose of study drug
- Pregnancy or nursing
- Other conditions that unsuitable for enrollment considered by Investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
About this study
Official title: A Single-center, Randomized, Doule Blind, Placebo-controlled, Multiple Dose Escalation Phase 1b Study to Evaluate the Safety and Tolerability of Aolanti Weikang Tablets in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers
Read the detailed description
This is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level, subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up for 14 days. No intrapatient dose-escalation is permitted.
- Conditions
- Functional Dyspepsia
- Being tested
- Aolanti Weikang tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aolanti Weikang tabletsDrug
Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Aolanti Weikang tablets | Experimental | 3，6 or 8 Aolanti Weikang tablets each time,tid Receives: Drug: Aolanti Weikang tablets |
| Placebo | Placebo comparator | 3,6 or 8 tablets each time,tid Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets
Definition of MTD: the dose level at which 3 or more subjects experienced one or more dose limited toxicities
Measured: 3 weeks
Secondary outcomes (1)
Number and grade of treatment-related adverse events (AEs)
All of the AE are assessed by NCI-CTCAE v4.03
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start14 Dec 2017
- Primary completion21 Apr 2018
- Study completion30 Jun 2018
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xudong Tang, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358485
- Sponsor's protocol ID
- QF-WKP-101
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2017
- Last updated
- 15 Aug 2018
- 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 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Doule Blind, Placebo-controlled, Multiple Dose Escalation Phase 1b Study to Evaluate the Safety and Tolerability of Aolanti Weikang Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03358485
- Acronym / sponsor ID
- QF-WKP-101
- Conditions
- Functional Dyspepsia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 21 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 30 Nov 2017 (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 tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers
Detailed description
This is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level, subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up for 14 days. No intrapatient dose-escalation is permitted.
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 Weikang tablets | Experimental | Drug: Aolanti Weikang tablets3，6 or 8 Aolanti Weikang tablets each time,tid |
| Placebo | Placebo comparator | Other: Placebo3,6 or 8 tablets each time,tid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) :≥19 and ≤26 kg/m2
- Signed written informed consent
Key exclusion criteria (12 listed)
- With in 7 days of Screening, the average number of stool > 2 times/day
- With in 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale
- At least one clinically significant abnormality based the comprehensive examination (including vital signs, physical examination, laboratory examination and others)
- Digestive diseases, or other diseases within 3 months that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator
- Smoking, alcohol abuse or drug abuse with in 3 months or drinking within 48 hours before the first administration
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 Weikang tabletsAolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). | Drug | Aolanti Weikang tablets |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets
Time frame: 3 weeks
Definition of MTD: the dose level at which 3 or more subjects experienced one or more dose limited toxicities
1 secondary outcome
Number and grade of treatment-related adverse events (AEs)
Time frame: 3 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 15 Aug 2018.
- 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.
Xudong Tang principal investigator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aolanti Weikang 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 2 inclusion and 12 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 15 Aug 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets (time frame: 3 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 15 Aug 2018.