Motion SicknessPhase 2NCT02241629
Levo Phencynonate Hydrochloride for the Prevention of Seasickness
A Phase 2 study testing levo phencynonate hydrochloride in people with Motion Sickness, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- levo phencynonate hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Feb 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects fulfilling the diagnostic criteria for motion sickness
- Have medical history for motion sickness
- During screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale.
- Adults for 18-55 years, male or female.
- Agree to participate the study and can sign the ICF independently.
Who cannot join
- Be allergic to the study drug or be allergic constitution
- ALT, AST≥ 1.5 times of ULN, Scr>ULN, or other clinical significant lab values.
- Abnormal ECG which is clinical significant judged by investigators, including: QTc>normal range
- Have medical history for urination disorder
- Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness.
- Have active gastrointestinal diseases or overweight (BMI≥24kg/m2 )
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- Have internal ear disease which may disturb the evaluation of motion sickness.
- Have glaucoma or posterior circulation ischemia
- Have anxiety, depression or other mental disease that investigator considering inadaptable to participate the study.
- Participated in other studies within the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study
A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.
Read the detailed description
The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the impact of voyage experience. 3) On-boat drug testing period. The subjects will be administered the drug before voyage. The seasickness symptoms will be evaluated during voyage. The safety test will be conducted before and after one day of on-boat testing.
- Conditions
- Motion Sickness
- Being tested
- placebo, levo phencynonate hydrochloride
- Keywords
- motion sickness
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo of levo phencynonate hydrochloride
levo phencynonate hydrochlorideDrug
levo phencynonate hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| levo phencynonate hydrochloride 1mg | Experimental | levo phencynonate hydrochloride tablet 1mg Receives: Drug: placebo; Drug: levo phencynonate hydrochloride |
| placebo | Placebo comparator | Placebo Receives: Drug: placebo |
| levo phencynonate hydrochloride 2mg | Experimental | levo phencynonate hydrochloride 2mg Receives: Drug: levo phencynonate hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
the symptoms of seasickness
Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.
Measured: Two hours of voyage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiguo Xue, Principal investigator, Qingdao Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241629
- Sponsor's protocol ID
- BOJI-1423Q
- Status last verified
- Sep 2014
- First submitted
- 12 Sep 2014
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study
- ClinicalTrials.gov ID
- NCT02241629
- Acronym / sponsor ID
- BOJI-1423Q
- Conditions
- Motion Sickness
- Keywords
- motion sickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Sep 2014 (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.
A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.
Detailed description
The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the impact of voyage experience. 3) On-boat drug testing period. The subjects will be administered the drug before voyage. The seasickness symptoms will be evaluated during voyage. The safety test will be conducted before and after one day of on-boat testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| levo phencynonate hydrochloride 1mg | Experimental | Drug: placebo, Drug: levo phencynonate hydrochloridelevo phencynonate hydrochloride tablet 1mg |
| placebo | Placebo comparator | Drug: placeboPlacebo |
| levo phencynonate hydrochloride 2mg | Experimental | Drug: levo phencynonate hydrochloridelevo phencynonate hydrochloride 2mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects fulfilling the diagnostic criteria for motion sickness
- Have medical history for motion sickness
- During screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale.
- Adults for 18-55 years, male or female.
- Agree to participate the study and can sign the ICF independently.
Key exclusion criteria (10 listed)
- Be allergic to the study drug or be allergic constitution
- ALT, AST≥ 1.5 times of ULN, Scr>ULN, or other clinical significant lab values.
- Abnormal ECG which is clinical significant judged by investigators, including: QTc>normal range
- Have medical history for urination disorder
- Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness.
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 |
|---|---|---|
| placeboplacebo of levo phencynonate hydrochloride | Drug | levo phencynonate hydrochloride 1mg, placebo |
| levo phencynonate hydrochloridelevo phencynonate hydrochloride | Drug | levo phencynonate hydrochloride 1mg, levo phencynonate hydrochloride 2mg |
Primary outcome
the symptoms of seasickness
Time frame: Two hours of voyage
Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.
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 7 May 2015.
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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.
Weiguo Xue principal investigator
Qingdao Municipal Hospital
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 levo phencynonate hydrochloride in people with Motion Sickness, run by Sihuan Pharmaceutical Holdings Group 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 5 inclusion and 10 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 7 May 2015. 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?
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?
the symptoms of seasickness (time frame: Two hours of voyage). 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 7 May 2015.