Text Size

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

This study has been terminated.
Sponsor:
Collaborator:
Compellis Pharmaceuticals
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01021176
First received: November 24, 2009
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Food Intake
 Other: Placebo spray
Drug: Diltiazem
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 5.5, 6.0, 6.3 and/or one more randomly

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021176

Locations
United States, Louisiana
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
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01021176     History of Changes
Other Study ID Numbers: PBRC27016
Study First Received: November 24, 2009
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pennington Biomedical Research Center:
Food Intake
Hunger
Lidocaine
Nose
smell

Additional relevant MeSH terms:
Diltiazem
Verapamil
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on May 16, 2013