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Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell

NCT ID: NCT01021176

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to determine whether the blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray which will then reduce food intake.

Detailed Description

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You will fast on your first visit. Complete questionnaire about taste and smell to insure you don't have a cold or anything that would interfere with sense of smell. Your nose will be checked. Blood pressure taken, and administer to you a spray with diltiazem 2, 4, 8 mg or a placebo. Your sense of smell will be tested at different time points.

Conditions

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Food Intake

Keywords

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Food Intake Hunger Lidocaine Nose smell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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0mg 0 spray

No Diltiazem

Group Type PLACEBO_COMPARATOR

Placebo spray

Intervention Type OTHER

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered

2mg 2 Spray

Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 2mg/2 spray Diltiazem

Group Type ACTIVE_COMPARATOR

Diltiazem

Intervention Type DRUG

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.

4mg 4 Spray

Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 4mg/4 spray Diltiazem

Group Type ACTIVE_COMPARATOR

Diltiazem

Intervention Type DRUG

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.

8mg 8 spray

Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 8mg/8 spray Diltiazem

Group Type ACTIVE_COMPARATOR

Diltiazem

Intervention Type DRUG

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.

Interventions

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Placebo spray

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered

Intervention Type OTHER

Diltiazem

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.

Intervention Type DRUG

Other Intervention Names

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Placebo 5.5, 6.0, 6.3 and/or one more randomly

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 25 and 40 kg
* Blood pressure in within normal range

Exclusion Criteria

* Used tobacco products in the past month
* Used a calcium channel blocker medication in the last month
* used nasal sprays in the last month
* have an abnormal sense of smell or abnormalities of the lining in your nose
* female and have irregular menstrual periods
* female and are nursing a baby or pregnant
* female and have had a partial hysterectomy (still have ovaries)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Compellis Pharmaceuticals

UNKNOWN

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank L. Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 27016

Identifier Type: -

Identifier Source: org_study_id