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

Food Intake Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01021176
• Other study ID #: PBRC 27016
• Status: Terminated
• Phase: Phase 1
• First received: November 24, 2009
• Last updated: December 17, 2015
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Food Intake

Intervention

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

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Compellis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray.		3 weeks	No