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

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01021176
Collaborator
Compellis Pharmaceuticals (Other)
12
Enrollment
1
Location
4
Arms
1
Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray. [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center
    • Compellis Pharmaceuticals

    Investigators

    • Principal Investigator: Frank L. Greenway, MD, Pennington Biomedical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT01021176
    Other Study ID Numbers:
    • PBRC 27016
    First Posted:
    Nov 26, 2009
    Last Update Posted:
    Dec 18, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
    Food Intake
    Hunger
    Lidocaine
    Nose
    smell
    Additional relevant MeSH terms:
    Diltiazem

    Study Results

    No Results Posted as of Dec 18, 2015