NauseaEarly Phase 1NCT01684969
Evidence of Haloperidol Absorption After Topical Administration
A Early Phase 1 study testing Haloperidol in people with Nausea and Vomiting, run by Eric E. Prommer.
Trial summary
This will be a blinded study to compare the absorption of topical haloperidol with placebo Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Haloperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- Phase
- Early 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: patient must be 18 years or older and less than 70 years of age.
- Provision of informed consent
- No previous adverse reaction to haloperidol
- No current use of haloperidol
- Good health
- No alcohol within 24 hours of the study
Show all 16Show fewer
- No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
- Normal neurologic exam
- Exclusionary Criteria
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- Recent cerebral trauma
- Study will exclude women who are pregnant and/or nursing
- Women who are of child bearing potential must have a negative urine pregnancy test.
- History of seizures
- Taking medications that can interact with haloperidol
- Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
Who cannot join
None listed.
About this study
Official title: Topical Haloperidol: Evidence of Absorption After Topical Administration
This will be a blinded study to compare the absorption of topical haloperidol with placebo
- Being tested
- Haloperidol, Placebo
- Keywords
- Nausea, vomiting, gastrointestinal symptoms, palliative care
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
0.5 mg iv x one dose
PlaceboDrug
0.5 mg iv , one dose
| Study group | Role | What they receive |
|---|---|---|
| intravenous haloperidol | Active comparator | intravenous haloperidol pharmacokinetics Receives: Drug: Haloperidol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.
Measuring either the presence of absence of haloperidol
Measured: baseline to 240 minutes after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: lack of accrual and funding is about to expire.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric E. Prommer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric E. Prommer, Mayo Clinic
- Investigators
- Eric Prommer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684969
- Sponsor's protocol ID
- 11-005661
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2012
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Haloperidol: Evidence of Absorption After Topical Administration
- ClinicalTrials.gov ID
- NCT01684969
- Acronym / sponsor ID
- 11-005661
- Keywords
- Nausea, vomiting, gastrointestinal symptoms, palliative care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of accrual and funding is about to expire.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eric E. PrommerUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Sep 2012 (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.
This will be a blinded study to compare the absorption of topical haloperidol with placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous haloperidol | Active comparator | Drug: Haloperidolintravenous haloperidol pharmacokinetics |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age: patient must be 18 years or older and less than 70 years of age.
- Provision of informed consent
- No previous adverse reaction to haloperidol
- No current use of haloperidol
- Good health
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Haloperidol0.5 mg iv x one dose | Drug | intravenous haloperidol |
| Placebo0.5 mg iv , one dose | Drug | Placebo |
Primary outcome
To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.
Time frame: baseline to 240 minutes after administration.
Measuring either the presence of absence of haloperidol
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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.
Eric Prommer, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Haloperidol in people with Nausea and Vomiting, run by Eric E. Prommer.
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 16 inclusion and 0 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: withdrawn, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration. (time frame: baseline to 240 minutes after administration.). 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 17 Mar 2016.