Motion SicknessPhase 3NCT05548270
Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion
A Phase 3 study testing DPI-386 Nasal Gel in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating DPI-386 Nasal Gel versus placebo. Approximately 500 subjects will be randomized 1:1 (250 DPI 386 Nasal Gel/250 matching Placebo Nasal Gel) are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- DPI-386 Nasal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 503 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 29 Nov 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability in the opinion of the Investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications.
- Male and female subjects ≥18 years of age.
- Susceptible to provocative motion as evidenced by at least three responses of "Frequently" from the Motion Sickness Susceptibility Questionnaire Short-Form (MSSQ-Short).
- Acceptable overall medical condition to be safely enrolled in and complete the study in the opinion of the Investigator.
- Ability to take intranasal medication.
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is 2 years postmenopausal), or females of child-bearing potential using an acceptable method of birth control (i.e., oral contraception, systemic [injectable or patch] contraception, double barrier methods, strict abstinence, condoms, diaphragm, spermicidal agents, cervical cap, copper intrauterine device, etc.) for a period of up to 30 days before dosing and for one month after dosing and must have a negative pregnancy test at screening.
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- Agree to adhere to the following lifestyle compliance considerations:
- Refrain from consumption of grapefruit and any substance containing grapefruit for 7 days prior to, during, and 7 days after study drug administration;
- Abstain from alcohol for 24 hours prior to the administration of study drug and throughout the ocean travel;
- Abstain from marijuana within the 7-day period prior to the Treatment Day and throughout Day 2.
- Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-COV-2) negative test, confirmed by Food and Drug Administration (FDA) authorized COVID-19 test ≤ 7 days prior to study drug administration or no COVID 19 symptoms 10 days prior to study drug administration.
Who cannot join
- Nauseated prior to boarding.
- Mini-Mental State Examination score of <24.
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who:
- Are or intend to become pregnant (including use of fertility drugs) during the study;
- Are nursing (female subjects only);
- Are not using an acceptable, highly effective method of contraception until all follow up procedures are complete.
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- Known allergic reactions to scopolamine or other anticholinergics.
- Hospitalization or significant surgery requiring hospital admittance within the past 6 months.
- Treatment with another investigational product within the past 30 days.
- Donated blood or plasma or suffered significant blood loss within the past 30 days.
- Chronic nausea caused by conditions such as irritable bowel syndrome, gastroparesis, cyclic vomiting syndrome or any other cause.
- Having any of the following medical conditions within the last 2 years or if any of the following medical conditions were experienced more than 2 years ago and are deemed as clinically significant by the Investigator:
- Significant gastrointestinal disorder, asthma, or seizure disorders;
- History of or current cardiovascular disease;
- History of or current vestibular disorders;
- History of or current narrow-angle glaucoma;
- History of or current urinary retention problems; or
- History of or current alcohol or drug abuse.
- Has had any prior nasal, nasal sinus, or nasal mucosa surgery.
- Currently taking any of the following medication types within the specified washout period:
- Any form of scopolamine (including Transderm Scop®/washout 5 days;
- Belladonna alkaloids/washout 14 days;
- Antihistamines (including meclizine/washout 14 days;
- Tricyclic antidepressants/washout 14 days;
- Muscle relaxants/washout 4 days; or
- Nasal decongestants/washout 4 days.
- Has used marijuana within the 7-day period prior to the Treatment Day. (Note: this criterion will only be confirmed at Eligibility Confirmation, not at Recruitment and Screening, although heavy users of marijuana can be determined ineligible at Screening. All potential study subjects deemed eligible at Screening must be informed at that time that this requirement must be met at Eligibility Confirmation.).
- Unwilling or unable to follow the medication restrictions or unwilling to wash-out the use of restricted medications as noted in Exclusion Criterion #11.
- Subject participated in a previous study of DPI-386 Nasal Gel.
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Monica Clinical Trials
Santa Monica, California, 90404
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion
This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating DPI-386 Nasal Gel versus placebo. Approximately 500 subjects will be randomized 1:1 (250 DPI 386 Nasal Gel/250 matching Placebo Nasal Gel) are planned to be enrolled.
Read the detailed description
The purpose of this study (DPI-386-MS-33) is to prospectively evaluate the difference in the rate of complete response, defined as no vomiting and no rescue treatment (e.g., antihistamine) within the 4-hour period after study drug administration, or to the end of the voyage, whichever comes later, between 0.2 mg scopolamine administered as the DPI-386 Nasal Gel and Placebo Nasal Gel to subjects ≥18 years of age (inclusive) with a history of symptoms consistent with motion sickness (MS). The sample size of 250 subjects per treatment arm is considered sufficient to demonstrate a statistically significant difference between treatments.
- Conditions
- Motion Sickness
- Being tested
- DPI-386 Nasal Gel, Placebo
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPI-386 Nasal GelDrug
Also called scopolamine
Subjects will self-administer DPI-386 Nasal Gel or Placebo
PlaceboDrug
Subjects will self-administer DPI-386 Nasal Gel or Placebo
| Study group | Role | What they receive |
|---|---|---|
| DPI-386 | Experimental | Each 0.12 gram of the gel contains0.2 mg of scopolamine HBr Receives: Drug: DPI-386 Nasal Gel |
| Placebo | Placebo comparator | Placebo Nasal Gel (0.12 g) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Report no Vomiting Within 4 Hours or to end of voyage, whichever comes later after Receiving Study Drug and no Use of Rescue Treatment
Proportion of subjects who report no vomiting within 4 hours or to end of voyage, whichever comes later, after receiving study drug and no use of rescue treatment (e.g., antihistamine) within 4 hours or to end of voyage, whichever comes later, after receiving study drug (Complete Responders).
Measured: 4 hours
Secondary outcomes (3)
Time to vomiting or use of rescue medication
Measured: 4 hours
Proportion of subjects who did not have moderate or severe nausea, which is defined as those subjects who report no moderate and severe nausea within 4 hours after receiving study drug and who did not use rescue treatment
Proportion of subjects who did not have moderate or severe nausea, which is defined as those subjects who report no moderate and severe nausea within 4 hours after receiving study drug and who did not use rescue treatment (e.g., antihistamine) within 4 hours after receiving study drug.
Measured: 4 hours
Proportion of subjects who did not have nausea, which is defined as those subjects who report no nausea within 4 hours after receiving study drug and who did not use rescue treatment
Proportion of subjects who did not have nausea, which is defined as those subjects who report no nausea within 4 hours after receiving study drug and who did not use rescue treatment (e.g., antihistamine) within 4 hours after receiving study drug.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start23 Aug 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repurposed Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Helton, Study director, Defender Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548270
- Sponsor's protocol ID
- DPI-386-MS-33
- Status last verified
- Mar 2023
- First submitted
- 16 Sep 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion
- ClinicalTrials.gov ID
- NCT05548270
- Acronym / sponsor ID
- DPI-386-MS-33
- Conditions
- Motion Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Repurposed Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 21 Sep 2022 (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.
This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating DPI-386 Nasal Gel versus placebo. Approximately 500 subjects will be randomized 1:1 (250 DPI 386 Nasal Gel/250 matching Placebo Nasal Gel) are planned to be enrolled.
Detailed description
The purpose of this study (DPI-386-MS-33) is to prospectively evaluate the difference in the rate of complete response, defined as no vomiting and no rescue treatment (e.g., antihistamine) within the 4-hour period after study drug administration, or to the end of the voyage, whichever comes later, between 0.2 mg scopolamine administered as the DPI-386 Nasal Gel and Placebo Nasal Gel to subjects ≥18 years of age (inclusive) with a history of symptoms consistent with motion sickness (MS). The sample size of 250 subjects per treatment arm is considered sufficient to demonstrate a statistically significant difference between treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPI-386 | Experimental | Drug: DPI-386 Nasal GelEach 0.12 gram of the gel contains0.2 mg of scopolamine HBr |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Nasal Gel (0.12 g) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability in the opinion of the Investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications.
- Male and female subjects ≥18 years of age.
- Susceptible to provocative motion as evidenced by at least three responses of "Frequently" from the Motion Sickness Susceptibility Questionnaire Short-Form (MSSQ-Short).
- Acceptable overall medical condition to be safely enrolled in and complete the study in the opinion of the Investigator.
- Ability to take intranasal medication.
Key exclusion criteria (29 listed)
- Nauseated prior to boarding.
- Mini-Mental State Examination score of <24.
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who:
- Known allergic reactions to scopolamine or other anticholinergics.
- Hospitalization or significant surgery requiring hospital admittance within the past 6 months.
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 |
|---|---|---|
| DPI-386 Nasal GelAlso: scopolamineSubjects will self-administer DPI-386 Nasal Gel or Placebo | Drug | DPI-386 |
| PlaceboSubjects will self-administer DPI-386 Nasal Gel or Placebo | Drug | Placebo |
Primary outcome
Proportion of Participants Who Report no Vomiting Within 4 Hours or to end of voyage, whichever comes later after Receiving Study Drug and no Use of Rescue Treatment
Time frame: 4 hours
Proportion of subjects who report no vomiting within 4 hours or to end of voyage, whichever comes later, after receiving study drug and no use of rescue treatment (e.g., antihistamine) within 4 hours or to end of voyage, whichever comes later, after receiving study drug (Complete Responders).
3 secondary outcomes
Time to vomiting or use of rescue medication
Time frame: 4 hours
Proportion of subjects who did not have moderate or severe nausea, which is defined as those subjects who report no moderate and severe nausea within 4 hours after receiving study drug and who did not use rescue treatment
Time frame: 4 hours
Proportion of subjects who did not have nausea, which is defined as those subjects who report no nausea within 4 hours after receiving study drug and who did not use rescue treatment
Time frame: 4 hours
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 21 Mar 2023.
- 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.
David Helton study director
Defender Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DPI-386 Nasal Gel in people with Motion Sickness, run by Repurposed Therapeutics, Inc. at 1 site in United States.
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 11 inclusion and 29 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 21 Mar 2023. 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 United States. 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 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?
Proportion of Participants Who Report no Vomiting Within 4 Hours or to end of voyage, whichever comes later after Receiving Study Drug and no Use of Rescue Treatment (time frame: 4 hours). 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 21 Mar 2023.