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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on July 31, 2014