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

December 17, 2015 updated by: Frank Greenway, Pennington Biomedical Research Center

A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 0mg 0 spray
No Diltiazem
Other: Placebo spray
0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered
Other Names:
  • Placebo
Active Comparator: 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
Drug: 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.
Other Names:
  • 5.5, 6.0, 6.3 and/or one more randomly
Active Comparator: 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
Drug: 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.
Other Names:
  • 5.5, 6.0, 6.3 and/or one more randomly
Active Comparator: 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
Drug: 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.
Other Names:
  • 5.5, 6.0, 6.3 and/or one more randomly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray.
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Compellis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 26, 2009

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 27016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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