Evidence of Haloperidol Absorption After Topical Administ... | NCT01684969

Studies
Evidence of Haloperidol Absorption After Topical Administration

NCT01684969

Sponsor

Eric E. Prommer

Status

Withdrawn

Last Update Posted

Mar 17, 2016Estimated

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Nausea
Vomiting

Interventions

Haloperidol
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of accrual and funding is about to expire.

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Mar 19, 2012

First Submission Date that Met QC Criteria

Sep 10, 2012

First Posted Date

Sep 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2016

Last Update Posted Date

Mar 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intravenous haloperidol	Active Comparator	intravenous haloperidol pharmacokinetics	Drug: Haloperidol
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haloperidol	Drug	0.5 mg iv x one dose	intravenous haloperidol
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.	Measuring either the presence of absence of haloperidol	baseline to 240 minutes after administration.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Eric Prommer, MD	Mayo Clinic	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006220	Haloperidol

Ancestor Terms

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided